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Start Preamble Health Resources how much lasix cost and Services Administration (HRSA), Department of Health and Human Services (HHS). Notice. In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME how much lasix cost or Council) will hold public meetings for the 2021 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​index.html. COGME meetings will be held on April 14, 2021, 8:30 a.m.-5:00 p.m.

Eastern Time (ET) and April 15, 2021, how much lasix cost 8:30 a.m.-2:00 p.m. ET. August 19, 2021, 10:00 a.m.-5:00 p.m. ET. Meetings may be held in-person, by teleconference, and/or Adobe Connect webinar.

For updates on how the meeting will be held, visit the COGME website 30 business days before the date of the meeting where instructions for joining meetings either in-person or remotely will also be posted. In-person meetings will be held at 5600 Fishers Lane, Rockville, Maryland 20857. For meeting information updates, go to the COGME website meeting page at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​meetings/​index.html. Start Further Info Shane Rogers, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 15N142, Rockville, Maryland 20857. 301-443-5260.

Or SRogers@hrsa.gov. End Further Info End Preamble Start Supplemental Information COGME makes recommendations to the Secretary of HHS (Secretary) and Congress on policy, program development, and other matters of significance as specified by section 762 of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses. Foreign medical school graduates. The nature and financing of undergraduate and graduate medical education.

Appropriation levels for certain programs under Title VII of the PHS Act. And deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. COGME submits reports to the Secretary of HHS. The Senate Committee on Health, Education, Labor and Pensions. And the House of Representatives Committee on Energy and Commerce.

Additionally, COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of the Council. Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change. For CY 2021 meetings, agenda items may include, but are not limited to, discussion on topics surrounding rural health workforce and training. Refer to the COGME website listed above for all current and updated information concerning the CY 2021 COGME meetings, including draft agendas and meeting materials that will be posted 30 calendar days before the meeting. Members of the public will have the opportunity to provide comments.

Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to COGME should be sent to Shane Rogers using the contact information above at least 5 business days before the meeting date(s). Individuals who need special assistance or another reasonable accommodation should notify Shane Rogers using the contact information listed above at least 10 business days before the meeting(s) they wish to attend. If a meeting is held in-person, it will occur in a federal government building and attendees must go through a security check to enter.

Non-U.S. Citizen attendees must notify HRSA of their planned attendance at an in-person meeting at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Start Signature Maria G. Button, Director, Executive Secretariat.

End Signature End Supplemental Information [FR Doc. 2021-00058 Filed 1-7-21. 8:45 am]BILLING CODE 4165-15-P.

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Notes1 http://www.teawamaori.com/buy-propecia-5mg-online/ lasix renogram cpt code. R. C Keller (2006) lasix renogram cpt code. "Geographies of power, legacies of mistrust. Colonial medicine in the global present." Historical Geography no.

34:26-48.2. Bridget Pratt et al. (2018). "Exploring the ethics of global health research priority-setting." BMC Medical Ethics no. 19 (94).

Doi. 10.1186/s12910-018-0333-y3. Richard Horton (2013). "Offline. Is global health neocolonialist?.

" The Lancet no. 382 (9906):1690. Doi. 10.1016/S0140-6736(13)62379-X4. Anonymous (2019).

"Editorial. Break with tradition. The World Health Organization’s decision about traditional Chinese medicine could backfire." Nature no. 570:5.5. S.

S Amrith (2006). Decolonizing international health. India and Southeast Asia, 1930–65. London. Palgrave Macmillan.6.

Arturo Escobar and A Escobar (1984). "Discourse and power in development. Michel Foucault and the relevance of his work to the third world." Alternatives no. 10 (3):377-400. Doi.

10.1177/0304375484010003047. UNDG (2013). A million voices. The world we want. A sustainable future with dignity for all.

New York, NY. United Nations Development Group.8. WHO (2019). Speech by the Director-General. Transforming for impact 2019 (cited 10 March 2019).

Available from. Https://www.who.int/dg/speeches/detail/transforming-for-impact.9. R. C Keller (2006). Geographies of power, legacies of mistrust.

Colonial medicine in the global present.10. Mishal S Khan et al. (2019). Durrance-Bagale, H. Legido-Quigley "‘LMICs as reservoirs of AMR’.

A comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan." Health Policy and Planning no. 34 (3):178–187. Doi. 10.1093/heapol/czz02211. Clare I R Chandler (2019).

"Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure." Palgrave Communications no. 5 (1):53. Doi. 10.1057/s41599-019-0263-412.

In the area of antimicrobial use for human health, other problem areas include, for example, public hygiene and disease prevention, regulated access to medicines, disease diagnosis, or market conditions for the development of new antimicrobials. The Review on Antimicrobial Resistance (2016). Tackling drug-resistant s globally. Final report and recommendations. London.

The UK Prime Minister, WHO (2015b). Global action plan on antimicrobial resistance. Geneva. World Health Organization, Conan MacDougall and Ron E Polk (2005). "Antimicrobial stewardship programs in health care systems." Clinical Microbiology Reviews no.

18 (4):638-656. Doi. 10.1128/CMR.18.4.638-656.2005.13. The Review on Antimicrobial Resistance. Tackling drug-resistant s globally.

Final report and recommendations.14. WHO, Global action plan on antimicrobial resistance.15. Maria R Gualano et al. (2015). "General population's knowledge and attitudes about antibiotics.

A systematic review and meta-analysis." Pharmacoepidemiology and Drug Safety no. 24 (1):2-10. Doi. 10.1002/pds.371616. H Haak and A.

Radyowijati (2010). "Determinants of antimicrobial use. Poorly understood, poorly researched." In Antimicrobial resistance in developing countries, edited by Sosa, Byarugaba, Amábile-Cuevas, Hsueh, Kariuki and Okeke, 283-300. New York, NY. Springer.17.

These problems persist despite encouraging trends. For example, the field is becoming increasingly multidisciplinary through the involvement of several United Nations agencies alongside WHO in governing AMR, and AMR policy narratives are slowly broadening the hitherto hyper-individualised and behaviour change focus of global action plans. Connor Rochford et al. (2018). "Global governance of antimicrobial resistance." The Lancet no.

391 (10134):1976-1978. Doi. 10.1016/S0140-6736(18)31117-6, WHO, FAO, and OIE (2018). Monitoring global progress on addressing antimicrobial resistance. Analysis report of the second round of results of AMR country self-assessment survey 2018.

Geneva. World Health Organization, Food and Agriculture Organization of the United Nations and World Organisation for Animal Health (OIE), WHO (2017). Antimicrobial Resistance Behaviour Change first informal technical consultation, 6-7 November, 2017 Château de Penthes, Geneva. Meeting Report. Geneva.

World Health Organization, Elise Klein and China Mills (2017). "Psy-expertise, therapeutic culture and the politics of the personal in development." Third World Quarterly no. 38 (9):1990-2008. Doi. 10.1080/01436597.2017.131927718.

Emma R M Cohen et al. (2008). "Public engagement on global health challenges." BMC Public Health no. 8 (168). Doi.

10.1186/1471-2458-8-16819. B Hamlyn et al. (2015).Factors affecting public engagement by researchers. A study on behalf of a consortium of UK public research funders. London.

TNS20. Research Councils UK (2011) Concordat for engaging the public with research. Research Councils UK. Swindon.21. C Wilson, P.

Manners, and S. Duncan (2014). Building an engaged future for UK higher education. Full report from the Engaged Futures consultation. Bristol.

National Co-ordinating Centre for Public Engagement.22. Also referred to as ‘community engagement’, ‘patient and public involvement’ (PPI) in research, or in some instances also as participatory research. S. Staniszewska et al. (2017).

"GRIPP2 reporting checklists. Tools to improve reporting of patient and public involvement in research." Research Involvement and Engagement no. 3 (13). Doi. 10.1186/s40900-017-0062-2, Jo Brett et al.

(2014). "Mapping the impact of patient and public involvement on health and social care research. A systematic review." Health Expectations no. 17 (5):637-650. Doi.

10.1111/j.1369-7625.2012.00795.x, Paulina O Tindana et al. (2007). "Grand challenges in global health. Community engagement in research in developing countries." PLOS Medicine no. 4 (e273).

Doi. 10.1371/journal.pmed.0040273, F Darroch and A. Giles (2014). "Decolonizing health research. Community-based participatory research and postcolonial feminist theory." Canadian Journal of Action Research no.

15 (3):22-36.23. J Redfern et al. (2018). "Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event." FEMS Microbiology Letters no.

365 (16). Doi. 10.1093/femsle/fny17524. Victoria Jane Hume et al. (2018).

"Biomedicine and the humanities. Growing pains." Medical Humanities no. 44 (4):230-238. Doi. 10.1136/medhum-2018-01148125.

Astrid Treffry-Goatley et al. (2018). Ibid. "Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach." 239-246.

Doi. 10.1136/medhum-2018-01147426. L Jordanova (2014). "Medicine and the visual arts." In Medicine, health and the arts. Approaches to medical humanities, edited by Bates, Bleakley and Goodman, 41-63.

Abingdon. Routledge.27. Angela Ross Perfetti (2018). "Fate and the clinic. A multidisciplinary consideration of fatalism in health behaviour." Medical Humanities no.

44 (1):59-62. Doi. 10.1136/medhum-2017-01131928. Devan Stahl et al. (2016).

"Seeing illness in art and medicine. A patient and printmaker collaboration." Ibid. No. 42 (3):155-159. Doi.

10.1136/medhum-2015-01083829. Jonatan Wistrand and J Wistrand (2017). "When doctors are patients. A narrative study of help-seeking behaviour among addicted physicians." Ibid. No.

43 (1):19-23. Doi. 10.1136/medhum-2016-01100230. T. R Cole, N.

S. Carlin, and R. A. Carson (2015). Medical humanities.

An introduction. New York, NY. Cambridge University Press.31. Daniel Holman and Erica Borgstrom (2016). "Applying social theory to understand health-related behaviours." Medical Humanities no.

42 (2):143-145. Doi. 10.1136/medhum-2015-01068832. Hume, et al., Biomedicine and the humanities. Growing pains.33.

A Carusi (2016). "Modelling systems biomedicine. Intertwinement and the 'real'." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 50-65. Edinburgh. Edinburgh University Press.34.

Jordanova, Medicine and the visual arts.35. Stahl and Stahl, Seeing illness in art and medicine. A patient and printmaker collaboration.36. William Viney et al. (2015).

"Critical medical humanities. Embracing entanglement, taking risks." Ibid. No. 41 (1):2-7. Doi.

10.1136/medhum-2015-01069237. J Cole and S. Gallagher (2016). "Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?.

" In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 377-394. Edinburgh. Edinburgh University Press.38. J Macnaughton and H. Carel (2016).

Ibid."Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap." In, 294-309.39. P J Pelto and G H Pelto (1997). 1997. "Studying knowledge, culture, and behavior in applied medical anthropology." Medical Anthropology Quarterly no.

11 (2):147-163.40. Lindsay Prior (2003) "Belief, knowledge and expertise. The emergence of the lay expert in medical sociology." Sociology of Health &. Illness no. 25 (3):41-57.

Doi. 10.1111/1467-9566.0033941. E Oliveira and J. Vearey (2018). "Making research and building knowledge with communities.

Examining three participatory visual and narrative projects with migrants who sell sex in South Africa." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 265-287. Cham. Springer.42. Komatra Chuengsatiansup and Wirun Limsawart (2019).

"Tuberculosis in the borderlands. Migrants, microbes and more-than-human borders." Palgrave Communications no. 5 (1):31. Doi. 10.1057/s41599-019-0239-443.

R Garden (2014). "Social studies. The humanities, narrative, and the social context of the patient-professional relationship." In Health humanities reader, edited by Jones, Wear, Friedman and Pachucki, 127-137. New Brunswick, NJ. Rutgers University Press.44.

Holman and Borgstrom, Applying social theory to understand health-related behaviours.45. Claas Kirchhelle (2018). "Pharming animals. A global history of antibiotics in food production (1935–2017)." Palgrave Communications no. 4 (96).

Doi. 10.1057/s41599-018-0152-246. Hannah Landecker (2019). "Antimicrobials before antibiotics. War, peace, and disinfectants." Ibid.

No. 5 (1):45. Doi. 10.1057/s41599-019-0251-847. Sue Walker (2019).

Ibid."Effective antimicrobial resistance communication. The role of information design." 24. Doi. 10.1057/s41599-019-0231-z48. Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.49.

May Sudhinaraset et al. (2013). "What is the role of informal healthcare providers in developing countries?. A systematic review." PLoS ONE no. 8 (2):e54978.

Doi. 10.1371/journal.pone.005497850. Viroj Tangcharoensathien, Sunicha Chanvatik, and Angkana Sommanustweechai (2018). "Complex determinants of inappropriate use of antibiotics." Bulletin of the World Health Organization no. 96 (2):141-144.

Doi. 10.2471/BLT.17.19968751. WHO (2015a). Antibiotic resistance. Multi-country public awareness survey.

Geneva. World Health Organization.52. WHO, Antibiotic resistance. Multi-country public awareness survey, 42.53. Gualano, et al.

General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis.54. Edward A Belongia et al. (2002). "Antibiotic use and upper respiratory s.

A survey of knowledge, attitudes, and experience in Wisconsin and Minnesota." Preventive Medicine no. 34 (3):346-352. Doi. 10.1006/pmed.2001.099255. Miao Yu et al.

(2014). "Knowledge, attitudes, and practices of parents in rural China on the use of antibiotics in children. A cross-sectional study." BMC Infectious Diseases no. 14 (112). Doi.

10.1186/1471-2334-14-11256. Abdelmoneim Ismail Awad and Esraa Abdulwahid Aboud (2015). "Knowledge, attitude and practice towards antibiotic use among the public in Kuwait." PLoS ONE no. 10 (2):e0117910. Doi.

10.1371/journal.pone.011791057. Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure.58. Jie Chang et al. (2018).

"Non-prescription use of antibiotics among children in urban China. A cross-sectional survey of knowledge, attitudes, and practices." Expert Review of Anti-infective Therapy no. 16 (2):163-172. Doi. 10.1080/14787210.2018.142561659.

Gualano, et al. General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis.60. A R McCullough et al. (2016).

"A systematic review of the public's knowledge and beliefs about antibiotic resistance." Journal of Antimicrobial Chemotherapy no. 71 (1):27-33. Doi. 10.1093/jac/dkv31061. Abel Santiago Muri-Gama, Albert Figueras, and Silvia Regina Secoli (2018).

"Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin. We need to promote more rational use even in remote places." PLoS ONE no. 13 (e0201579). Doi. 10.1371/journal.pone.020157962.

A Launiala (2009). "How much can a KAP survey tell us about people's knowledge, attitudes and practices?. Some observations from medical anthropology research on malaria in pregnancy in Malawi." Anthropology Matters no. 11 (1).63. Pamela Das et al.

(2016). "Antibiotics. Achieving the balance between access and excess." The Lancet no. 387 (10014):102-104. Doi.

10.1016/S0140-6736(15)00729-164. C Olivier et al. (2010). "Containing global antibiotic resistance. Ethical drug promotion in the developing world." In Antimicrobial resistance in developing countries, edited by Sosa, Byarugaba, Amábile-Cuevas, Hsueh, Kariuki and Okeke, 505-524.

New York, NY. Springer.65. Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure.66. Chandler, Current accounts of antimicrobial resistance.

Stabilisation, individualisation and antibiotics as infrastructure.67. Steve Hinchliffe, Andrea Butcher, and Muhammad Meezanur Rahman (2018). "The AMR problem. Demanding economies, biological margins, and co-producing alternative strategies." Ibid. No.

4 (142). Doi. 10.1057/s41599-018-0195-468. Chuengsatiansup and Limsawart, Tuberculosis in the borderlands. Migrants, microbes and more-than-human borders.69.

Khan, et al, ‘LMICs as reservoirs of AMR’. A comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan.70. Didier Wernli et al. (2017). "Mapping global policy discourse on antimicrobial resistance." BMJ Global Health no.

2 (e000378). Doi. 10.1136/bmjgh-2017-00037871. Nancy J Hawkings, Fiona Wood, and Christopher C Butler (2007). "Public attitudes towards bacterial resistance.

A qualitative study." Journal of Antimicrobial Chemotherapy no. 59 (6):1155-1160. Doi. 10.1093/jac/dkm10372. McCullough, et al.

A systematic review of the public's knowledge and beliefs about antibiotic resistance.73. Muri-Gama, et al. Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin. We need to promote more rational use even in remote places.74. David G Allison et al.

(2017). "Antibiotic resistance awareness. A public engagement approach for all pharmacists." International Journal of Pharmacy Practice no. 25 (1):93-96. Doi.

10.1111/ijpp.1228775. Mark Davis et al. (2018). "Understanding media publics and the antimicrobial resistance crisis." Global Public Health no. 13 (9):1158-1168.

Doi. 10.1080/17441692.2017.133624876. Simon J Howard et al. (2013). "Antibiotic resistance.

Global response needed." The Lancet Infectious Diseases no. 13 (12):1001-1003. Doi. 10.1016/S1473-3099(13)70195-677. Renly Lim et al.

(2016). "Village drama against malaria." The Lancet no. 388 (10063):2990. Doi. 10.1016/S0140-6736(16)32519-378.

Deborah Nyirenda et al. (2018). "Public engagement in Malawi through a health-talk radio programme ‘Umoyo nkukambirana’. A mixed-methods evaluation." Public Understanding of Science no. 27 (2):229-242.

Doi. 10.1177/096366251665611079. Redfern, et al. Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event.80.

Sungjong Roh et al. (2018). "Public understanding of One Health messages. The role of temporal framing." Public Understanding of Science no. 27 (2):185-196.

Doi. 10.1177/096366251667080581. Tindana, et al., Grand challenges in global health. Community engagement in research in developing countries.82. Mpoe Johannah Keikelame and Leslie Swartz (2019).

"Decolonising research methodologies. Lessons from a qualitative research project, Cape Town, South Africa." Global Health Action no. 12 (1):1561175. Doi. 10.1080/16549716.2018.156117583.

Keymanthri Moodley and Shenuka Singh (2016). "“It’s all about trust”. Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa." BMC Medical Ethics no. 17 (57). Doi.

10.1186/s12910-016-0140-284. Seye Abimbola (2020). "Beyond positive a priori bias. Reframing community engagement in LMICs (epub ahead of print)." Health Promotion International. Doi.

10.1093/heapro/daz02385. Keikelame and Swartz, Decolonising research methodologies. Lessons from a qualitative research project, Cape Town, South Africa.86. Kenneth M Boyd (2000). "Disease, illness, sickness, health, healing and wholeness.

Exploring some elusive concepts." Medical Humanities no. 26 (1):9-17. Doi. 10.1136/mh.26.1.987. Hume, et al., Biomedicine and the humanities.

Growing pains.88. I Bamforth (2000). "Kafka's uncle. Scenes from a world of trust infected by suspicion." Ibid. No.

26 (2):85-91. Doi. 10.1136/mh.26.2.8589. Wistrand, When doctors are patients. A narrative study of help-seeking behaviour among addicted physicians.90.

Garden, Social studies. The humanities, narrative, and the social context of the patient-professional relationship.91. A Harpin (2016). "Broadmoor performed. A theatrical hospital." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 577-595.

Edinburgh. Edinburgh University Press.92. Jordanova, Medicine and the visual arts.93. Stahl and Stahl, Seeing illness in art and medicine. A patient and printmaker collaboration.94.

K G Sweeney et al. (2001). "A comparison of professionals' and patients' understanding of asthma. Evidence of emerging dualities?. " Ibid.

No. 27 (1):20-25. Doi. 10.1136/mh.27.1.2095. Treffry-Goatley, et al., Community engagement with HIV drug adherence in rural South Africa.

A transdisciplinary approach.96. R. J Hester (2016). "Culture in medicine. An argument against competence." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 541-558.

Edinburgh. Edinburgh University Press.97. L Jerke, M. Prendergast, and W. Dobson (2018).

"Smoking cessation in mental health communities. A living newspaper applied theatre project." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 171-186. Cham. Springer.98.

Sweeney, et al. A comparison of professionals' and patients' understanding of asthma. Evidence of emerging dualities?. 99. S Switzer (2018).

"What’s in an image?. Towards a critical and interdisciplinary reading of participatory visual methods." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 189-207. Cham. Springer.100.

Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. , 378.101. Cole, et al. Medical humanities.

An introduction.102. J Herman (2001). "Medicine. The science and the art." Medical Humanities no. 27 (1):42-46.

Doi. 10.1136/mh.27.1.42103. [Viney, et al. Critical medical humanities. Embracing entanglement, taking risks.104.

R. K Yin (2003). Case study research. Design and methods. Thousand Oaks, CA.

Sage.105. Marco J Haenssgen et al. (2018)106. S. L Gilman (2015).

Illness and image. Case studies in the medical humanities. New York, NY. Taylor &. Francis.107.

HarbarthM Haughton (2018). Staging trauma. Bodies in shadow. London. Palgrave Macmillan.108.

S Hodge, J Robinson, and P Davis (2007). "Reading between the lines. The experiences of taking part in a community reading project." Medical Humanities no. 33 (2):100-104. Doi.

10.1136/jmh.2006.000256109. Hume, et al. Biomedicine and the humanities. Growing pains.110. Saam Idelji-Tehrani and Muna Al-Jawad (2019).

"Exploring gendered leadership stereotypes in a shared leadership model in healthcare. A case study." Ibid. No. 45:388-398. Doi.

10.1136/medhum-2018-011517111. Suze M P J Jans et al. (2012). "A case study of haemoglobinopathy screening in the Netherlands. Witnessing the past, lessons for the future." Ethnicity &.

Health no. 17 (3):217-239. Doi. 10.1080/13557858.2011.604126112. Hume, et al., Biomedicine and the humanities.

Growing pains.113. Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. 114. Macnaughton and Carel, Breathing and breathlessness in clinic and culture.

Using critical medical humanities to bridge an epistemic gap.115. Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.116. Prior, Belief, knowledge and expertise. The emergence of the lay expert in medical sociology.117. Gilman, Illness and image.

Case studies in the medical humanities.118. Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. 119. Macnaughton and Carel, Breathing and breathlessness in clinic and culture.

Using critical medical humanities to bridge an epistemic gap.120. C Teddlie and A. Tashakkori (2009). Foundations of mixed methods research. Integrating quantitative and qualitative approaches in the social and behavioral sciences.

Thousand Oaks, CA. Sage.121. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.122. Gian Luca Barbieri et al.

(2016). "Imagination in narrative medicine." Journal of Child Health Care no. 20 (4):419-427. Doi. 10.1177/1367493515625134123.

Treffry-Goatley, et al. Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.124. WHO (2016). World Antibiotic Awareness Week.

2016 campaign toolkit. Geneva. World Health Organization.125. Across the three villages, 67% of the workshop attendees were female and the average age of the attendees was 44 years (range. 18 to 81 years.

Based on subsequently collected survey data).126. Nutcha Charoenboon et al. (2019)127. We thank an anonymous reviewer for highlighting the potential hazards of reproducing hierarchies through methods intended to challenge them in the first place.128. The research was reviewed and approved by the University of Oxford Tropical Research Ethics Committee (Ref.

OxTREC 528-17), and it received local ethical approval in Thailand from the Mae Fah Luang University Research Ethics Committee on Human Research (Ref. REH 60099). The service evaluation of the photo exhibition involved anonymised data collection and received a waiver for ethical approval from the University of Warwick Humanities &. Social Sciences Research Ethics Committee (HSSREC). However, all evaluation form respondents explicitly consented to the data being reported in research publications.129.

Marco J Haenssgen et al. (2018)130. National Statistical Office (2012). The 2010 population and housing census. Changwat Chiang Rai.

Bangkok. National Statistical Office.131. Data on the individual level would entail duplication of observations should both census survey rounds be included. Step-level data were aggregated on the illness level for analysis.132. Claire Charlotte McKechnie (2014).

"Anxieties of communication. The limits of narrative in the medical humanities." Medical Humanities no. 40 (2):119-124. Doi. 10.1136/medhum-2013-010466133.

Carusi, Modelling systems biomedicine. Intertwinement and the 'real'.134. Garden, Social studies. The humanities, narrative, and the social context of the patient-professional relationship.135. Emma Sacks et al.

(2018). "Beyond the building blocks. Integrating community roles into health systems frameworks to achieve health for all." BMJ Global Health no. 3 (Suppl. 3):e001384.

Doi. 10.1136/bmjgh-2018-001384136. Sudhinaraset, et al. What is the role of informal healthcare providers in developing countries?. A systematic review.137.

G Bloom et al. (2015). Addressing resistance to antibiotics in pluralistic health systems. Brighton. University of Sussex138.

WHO (2007). Strengthening health systems to improve health outcomes. WHO’s framework for action. Geneva. World Health Organization.139.

Jordanova, Medicine and the visual arts.140. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.141. A Bleakley (2014). Ibid.

"Towards a 'critical medical humanities'." In, 17-26.142. Hume, et al., Biomedicine and the humanities. Growing pains.143. Nutcha Charoenboon et al. (2019)144.

Marco Haenssgen et al. (2018)145. WHO, World Antibiotic Awareness Week. 2016 campaign toolkit.146. The questionnaire did so by showing all survey respondents three images of common antibiotic capsules being used in Chiang Rai (green-blue.

Amoxicillin. Red-black. Cloxacillin. White-blue. Azithromycin—see questionnaire page 10 in the online supplementary material).

Respondents were asked to name what they saw, and all their answers were recorded (field-coded and as free text).147. The ‘desirability’ of the responses was field coded by the survey team. Sample responses (as instructed through the survey manual) for ‘desirable’ answers included, for example, “Only if the doctor says that I should”. Sample responses for ‘undesirable’ answers included “Yes, you can buy it in the shop over there!. € The variable should be interpreted as ‘the fraction of respondents who uttered a ‘desirable’ response’—the inverse is the fraction of responses that could not be deemed ‘desirable’ (eg, ‘do not know’ or ‘no opinion’).148.

Because recalled descriptions of medicine tend to be ambiguous, we limited our analysis to medicines where we had a high degree of certainty that they were an antibiotic. This was specifically the case if survey respondents mentioned common antibiotic descriptions such as ‘anti-inflammatory’, ‘amoxi’ or ‘colem’, if they indicated explicitly that they know what ‘anti-inflammatory medicine’ is (noting that the term describes antibiotics unambiguously in Thai), and if they subsequently mentioned any of the previously mentioned antibiotics during their description of an illness episode (conversely, we excluded cases were the medicine could not be confirmed as either antibiotic or non-antibiotic, including descriptions like ‘white powder’ or ‘green capsule’).149. Aristotle (1954). Rhetoric. Translated by Roberts.

New York, NY. Modern Library. Original edition, 350 BC.150. Arya Nielsen et al. (2007).

"The effect of gua sha treatment on the microcirculation of surface tissue. A pilot study in healthy subjects." EXPLORE no. 3 (5):456-466. Doi. 10.1016/j.explore.2007.06.001151.

Nithima Sumpradit et al. (2012). "Antibiotics Smart Use. A workable model for promoting the rational use of medicines in Thailand." Bulletin of the World Health Organization no. 90 (12):905-913.

Doi. 10.2471/BLT.12.105445152. C Muksong and K. Chuengsatiansup (2020). Forthcoming.

"Medicine and public health in Thai historiography. From an elitist view to counter-hegemonic discourse." In Health, pluralism and globalisation. A modern history of medicine in South-East Asia, edited by Monnais and Cook. London. The Wellcome Trust Centre for the History.153.

L Sringernyuang (2000). Availability and use of medicines in rural Thailand. Amsterdam. Amsterdam Institute for Social Science Research.154. Although this was not the focus of the current paper, we note for full disclosure that the workshops, too, had mixed behavioural impacts.

The poster making sessions in Chiang Rai demonstrated for instance how our conversations about drug resistance and the introduction of messages from the World Health Organization entailed at times problematic interpretations like, “You shouldn’t take medicines that you have never seen before”—the research team responded to such interpretations directly in order to avoid misunderstandings. In addition, previous behavioural analyses documented that, while workshop participants demonstrated higher levels of awareness of drug resistance, alignment of antibiotic use with global health recommendations was mixed, and in one case, a villager started selling antibiotics after the workshop. For more details on the behavioural analysis, see Nutcha Charoenboon et al. (2019) and Marco Haenssgen et al. (2018).155.

For example, Redfern, et al., Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event.156. Antoine Boivin et al. (2018). 2018.

"Patient and public engagement in research and health system decision making. A systematic review of evaluation tools (epub ahead of print)." Health Expectations. Doi. 10.1111/hex.12804157. Staniszewska, et al.

GRIPP2 reporting checklists. Tools to improve reporting of patient and public involvement in research.158. Jerke, et al. Smoking cessation in mental health communities. A living newspaper applied theatre project.159.

Switzer, What’s in an image?. Towards a critical and interdisciplinary reading of participatory visual methods.160. R. C Barfield and L. Selman (2014).

"Health and humanities. Spirituality and religion." In Health humanities reader, edited by Jones, Wear, Friedman and Pachucki, 376-386. New Brunswick, NJ. Rutgers University Press.161. Abimbola, Beyond positive a priori bias.

Reframing community engagement in LMICs (epub ahead of print), 1.162. Marco J Haenssgen et al. (2019)163. Marc Mendelson et al. (2017).

"Antibiotic resistance has a language problem." Nature no. 545 (7652):23-25. Doi. 10.1038/545023a164. Haak and Radyowijati, Determinants of antimicrobial use.

Poorly understood, poorly researched.165. S Harbarth and D. L. Monnet (2008). "Cultural and socioeconomic determinants of antibiotic use." In Antibiotic Policies.

Fighting Resistance, edited by Gould and van der Meer, 29-40. Boston, MA. Springer.166. K Sirijoti, P. Havanond Hongsranagon, and W.

Pannoi (2014). "Assessment of knowledge attitudes and practices regarding antibiotic use in Trang province, Thailand." Journal of Health Research no. 28 (5):299-307.167. Ramona K C Finnie et al. (2011).

"Factors associated with patient and health care system delay in diagnosis and treatment for TB in sub-Saharan African countries with high burdens of TB and HIV." Tropical Medicine &. International Health no. 16 (4):394-411. Doi. 10.1111/j.1365-3156.2010.02718.x168.

Haak and Radyowijati, Determinants of antimicrobial use. Poorly understood, poorly researched.169. Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure, 5.170. S Willson and K.

Miller (2014). "Data collection." In Cognitive interviewing methodology. A sociological approach for survey question evaluation, edited by Miller, Willson, Chepp and Padilla, 15-34. Hoboken, NJ. Wiley.171.

See Linda Mayoux and Robert Chambers (2005). "Reversing the paradigm. Quantification, participatory methods and pro-poor impact assessment." Journal of International Development no. 17 (2):271-298. Doi.

10.1002/jid.1214172. Howard S. Becker (1995). "Visual sociology, documentary photography, and photojournalism. It's (almost) all a matter of context." Visual Sociology no.

10 (1-2):5-14. Doi. 10.1080/14725869508583745173. J Prosser and D. Schwartz (2005).

"Photographs and the sociological research process." In Image-based research. A sourcebook for qualitative researchers, edited by Prosser, 101-115. London. Falmer.174. Treffry-Goatley, et al.

Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.175. Switzer, What’s in an image?. Towards a critical and interdisciplinary reading of participatory visual methods.176. Hume, et al.

Biomedicine and the humanities. Growing pains.177. Jordanova, Medicine and the visual arts, 60.178. Bleakley, Towards a 'critical medical humanities'.179. Nutcha Charoenboon et al.

(2019)180. Hume, et al. Biomedicine and the humanities. Growing pains.181. J.

P Ansloos (2018). €œTo speak in our own ways about the world, without shame”. Reflections on indigenous resurgence in anti-oppressive research.” In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 3-18. Cham.

Springer.182. Marco J Haenssgen (2019)183. Michael Etherton and Tim Prentki (2006). "Drama for change?. Prove it!.

Impact assessment in applied theatre." Research in Drama Education. The Journal of Applied Theatre and Performance no. 11 (2):139-155. Doi. 10.1080/13569780600670718184.

Susan Galloway (2009). "Theory-based evaluation and the social impact of the arts." Cultural Trends no. 18 (2):125-148. Doi. 10.1080/09548960902826143185.

Darquise Lafrenière and Susan M Cox (2013). "‘If you can call it a poem’. Toward a framework for the assessment of arts-based works." Qualitative Research no. 13 (3):318-336. Doi.

10.1177/1468794112446104IntroductionIn Australia, the USA and the UK, the number of hospital beds required for forensic mental health treatment doubled between 1996 and 2016.1 Current trends and future predictions suggest this demand will continue to grow. But, in an age where evidence-based practice is highly valued, the demand for new facilities already outpaces the availability of credible evidence to guide designers. This article reports findings from a desktop survey of current design practice across 31 psychiatric hospitals (24 forensic, 7 non-forensic) constructed or scheduled for completion between 2006 and 2022. Desktop surveys, as a form of research, are heavily relied on in architectural practice. Photographs and architectural drawings are analysed to understand both typical and innovative approaches to designing a particular building type.

While desktop surveys are sometimes supplemented by visits to exemplar projects (which might also be termed ‘fieldwork’), time pressures and budgetary constraints often preclude this. As the result of an academic–industry partnership, the research reported herein embraced practice-based research methods in conjunction with an academic approach. The data set available for the desktop survey was rich but incomplete. Security requirements restrict the public availability of complete floor plans and postoccupancy evaluations. To mitigate these limitations, knowledge was integrated from other disciplines, including environmental psychology, architectural history and professional practice.

With regard to the latter, knowledge is specifically around the design and consultation processes that guide the construction of these facilities. This knowledge was used to identify three contemporary hospitals that challenge accepted design practice and, we argue, in doing so have the potential to act as change-agents in the delivery of forensic mental healthcare. We define innovation as variation/s to common, or typical, architectural solutions that can positively improve patients’2 experience of these facilities in ways that directly support one, or a number, of key values underpinning forensic mental healthcare. While this article does not provide postoccupancy data to quantify the value of these innovations, we hope to encourage both designers and researchers to more closely consider these projects—particularly the way that spaces have been designed to benefit patient well-being—and the questions these designs raise for the future of forensic mental healthcare delivery.Now regarded as naïve is the 19th-century belief that architecture and landscape, if appropriately designed, can restore sanity.3 Yet contemporary research from the field of evidence-based design confirms that the built environment does play a role in the therapeutic process, even if that role does not determine therapeutic outcomes.4 Research regarding the design of forensic mental healthcare facilities remains limited. An article by Ulrich et al recommended that to reduce aggression patients should be accommodated in single rooms.

Communal areas should have movable furniture. Wards should be designed for low social densities. And accessible gardens should be provided.5 An earlier study by Tyson et al showed that lower ward densities can also positively improve patient–staff interactions.6 Commonly, however, the studies referenced above compared older-style mental health units with their contemporary replacements.7 There is little comparative research available that examines contemporary facilities for forensic mental healthcare, with the exception of one article that provided a comparative analysis of nine Swedish facilities, designed between 1990 and 2008.8 However, this article merely described the design aspirations and physical composition of each hospital without investigating the link between design aspiration, patient well-being and the resulting physical environment.There are two further limitations to evidence-based design research. The first is the extent to which data do not provide directly applicable design tactics. Systematic literature reviews typically provide a set of design recommendations but without suggesting to designers what the corresponding physical design tactics to achieve those recommendations might actually be.9 This is consistent for general hospital design.

For example, architects have been advised to provide spaces that are ‘psychosocially supportive’ since 2000, yet it was 2016 before a spatially focused definition of this term was provided, offering designers a more tangible understanding of what they should be aiming for.10 The second limitation is the breadth of research currently available. While rigorous and valuable, evidence-based design often overlooks the fact that architects must design across scales, from the master-planning scale—deciding where to place buildings of various functions within a site, and how to manage the safe movement of staff and patients between those buildings—to the scale of a bathroom door. How do you design a bathroom door to meet antiligature and surveillance requirements, to maintain patient safety, while still communicating dignity and respect for patients?. The available literature provides much to contemplate, but in terms of credible evidence much of this research is based on a single study, typically conducted within a single hospital context and often focused on a single aspect of design. This raises the question, is there really a compelling basis for regarding evidence-based design knowledge as more credible than knowledge generated about this building type from other disciplines?.

In light of the small amount of evidence available in this field, is there not a responsibility to use all the available knowledge?. While the discipline of evidence-based design has existed for three decades,11 purpose-designed buildings for the treatment of mental illness have been constructed for over three centuries. Researchers working within the field of architectural history also understand that patient experience is partially determined—for better or worse—by the decisions that designers make, and that models of care have been used to drive design outcomes since the establishment of the York Retreat in 1796. With their focus on moral treatment, the York Retreat influenced a shift in the way asylum design was approached, from the provision of safe custody to finding architectural solutions to support the restoration of sanity.12 Architectural historians also bring evidence to bear in respect of this design challenge, specifically knowledge of how the best architectural intentions can result in unanticipated (sometimes devastating) outcomes—and of the conditions that gave rise to those outcomes.13 There is a third, rich source of knowledge available to guide designers that, broadly speaking, academic researchers have yet to tap into. It is the knowledge produced by practitioners themselves.

Architects learn through experience, across multiple projects and through practice-based forms of enquiry that include desktop surveys (also referred to as precedent studies), user group consultations and gathering (often informal) postoccupancy data from their clients. Architects have already offered a range of tangible solutions to meet particular aspirations related to patient care. There is value in examining these existing design solutions to identify those capable of providing direct benefits to patients that might justify implementation across multiple projects. In understanding how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients, all available knowledge should be valued and integrated.Methodology. Embracing ‘mode two’ researchThis research was conducted within the context of a master­-planning and feasibility study, commissioned by a state government department, to investigate various international design solutions to inform future planning around forensic mental health service provisions in Victoria, Australia.

The industry-led nature of this project demanded a less conventional and more inclusive methodological approach. Tight timeframes precluded employing research methods that required ethics approvals (interviewing patients was not possible), while the timeframe and budget precluded the research team from conducting fieldwork. The following obstacles further limited a conventional approach:Postoccupancy evaluations of forensic psychiatric hospital facilities are seldom conducted and/or not made publicly available.14Published floor plans that would enable researchers to derive an understanding of the functional layouts and corresponding habits of occupancy within these facilities are limited owing to the security needs surrounding forensic psychiatric hospital sites.Available literature relevant to the design of forensic psychiatric hospital facilities provides few direct architectural recommendations to offer tactics for how the built environment might support the delivery of treatment.The team had to find a way to navigate these challenges in order to address the important question of how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients.‘Mode two’ is a methodological approach that draws on the strength of collaborations between academia and industry to produce ‘socially robust knowledge’ whose reliability extends ‘beyond the laboratory’ to real-world contexts.15 It shares commonalities with a phenomenological approach that attributes value to the prolonged, firsthand exposure of the researcher with the phenomenon in question.16 The inclusion of practising architects and academic researchers within the research team provided considerable expertise in the design, consultation and documentation of these facilities, alongside an understanding of the kinds of challenges that arise following the occupation of this building type. Mode two, as a research approach, also recognises that, while architects reference evidence-based design literature, this will not replace the processes through which practitioners have traditionally assembled knowledge about particular building types, predominantly desktop surveys.A desktop survey was undertaken to understand contemporary design practice within this building type. Forty-four projects were identified as relevant for the period 2006–2022 (31 forensic and 13 non-forensic psychiatric hospitals).

These included facilities from the UK, the USA, Canada, Denmark, Norway, Sweden, the United Arab Emirates and Ireland (online supplementary appendix 1). Sufficient architectural information was not available for 13 of these projects and they were excluded from the study. For the remaining 31 facilities, 24 accommodated forensic patients and 7 did not. Non-forensic facilities were included to enable an awareness of any significant programmatic or functional differences in the design responses created for forensic versus non-forensic mental health patients. Architectural drawings and photographs were analysed to identify general trends, alongside points of departure from common practice.

Borrowing methods from architectural history, the desktop survey was supplemented by other available information, including a mix of hospital-authored guidebooks (as provided to patients and visitors), architects’ statements, newspaper articles and literature from the field of evidence-based design. Available data varied for each of the 31 hospitals. Adopting a method from architectural theorist Thomas Markus, the materiality and placement of external and internal boundary lines were closely studied (assisted by Google Earth).17 When read in conjunction with the architectural drawings, boundary placement revealed information regarding patient access to adjacent landscape spaces.Supplemental materialA desktop survey has limitations. It cannot provide a conclusive understanding of how these spaces operate when occupied by patients and staff. While efforts were made to contact individual practices and healthcare providers to obtain missing details, such requests typically went unanswered.

This is likely owing to concerns of security, alongside the realities of commercial practice, concerns around intellectual property, and complex client and stakeholder arrangements that can act to prohibit the sharing of this information. To deepen the team’s understanding, a 2-day workshop was hosted to which two international architectural practices were invited to attend, one from the UK and one from the USA. Both practices had recently completed a significant forensic psychiatric hospital project. While neither of these facilities had been occupied at the time of the workshops, the architects were able to share their experiences relative to the research, design, and client and patient consultation processes undertaken. The Australian architects who led the research team also brought extensive experience in acute mental healthcare settings, which assisted in data analysis.To further mitigate the limitations of the desktop survey, understandings developed by the team were used as a basis for advisory panel discussions with staff.

Feedback was sought from five 60 min long, advisory panel sessions, each including four to six clinical/facilities staff (who attended voluntarily during work hours) from a forensic psychiatric hospital in Australia, where several participants recounted professional experience in both the Australian and British contexts. Each advisory panel session was themed relative to various aspects of contemporary design. (1) site/hospital layout, (2) inpatient accommodation, (3) landscape design and access, (4) staff amenities, and (5) treatment hubs (referred to as ‘treatment malls’ in the American context). These sessions enabled the research team to double-check our analysis of the plans and photographs, particularly our assumptions regarding the likely use, practicality and therapeutic value of particular spaces.Model for analysisWithin general hospital design, a range of indicators are used to measure the contribution of architecture to healing, such as the optimisation of lighting to support sleep, the minimisation of patient falls, or whether the use of single patient rooms assists with control.18 In mental health, however, where the therapeutic journey is based more on psychology than physiology, what metrics should be employed to evaluate the success of one design response over another in supporting patient care?. We suggest the first step is to acknowledge the values that underpin contemporary approaches to mental healthcare.

The second step is to translate those treatment values into corresponding spatial values using a value-led spatial framework.19 This provides a checklist for relating particular spatial conditions to specific values around patient care. For example, if the design intent is to optimise privacy and dignity for patients, then the design of bathrooms, relaxation and de-esculation spaces are all important spaces in respect of that therapeutic value. Highlighting this relationship can assist decision makers to more closely interrogate areas that matter most relative to achieving these values. To put this in context, optimising a bathroom design to prioritise a direct line of sight for staff might improve safety but also obstruct privacy and dignity for patients. While such decisions will always need to be carefully balanced, a value-led spatial framework can provide a touchstone for designers and stakeholders to revisit throughout the design process.To analyse the 31 projects examined within this project, we developed a framework (Table 1).

It recognises that a common approach to patient care can be identified across contemporary Australian, British and Canadian models:View this table:Table 1 Value-led spatial framework. Correlating treatment values with corresponding spaces within the hospital’s physical environmentThat patients be extended privacy and dignity to the broadest degree possible without impacting their personal safety or that of other patients or staff.That patients be treated within the least restrictive environment possible relative to the severity of their illness and the legal (or security) requirements attached to their care.That patients be afforded choice and independence relative to freedom of movement within the hospital campus (as appropriate to the individual), extending to a choice of social, recreational and treatment spaces.That patients’ progression through their treatment journey is reflected in the way the architecture communicates to hospital users.That opportunities for peer-led therapeutic processes and involvement of family and community-based care providers be optimised within a hospital campus. 20Table 1 assigns a range of architectural spaces and features that are relevant to each of the five treatment values listed. Architectural decisions related to these values operate across three scales. Context, hospital and individual.

Context decisions are those made in respect of a hospital’s location, including proximity to allied services, connections to public transport and distances to major metropolitan hubs. Decisions of this type are important relative to staffing recruitment and retention, and opportunities for research relative to the psychiatric hospital’s proximity to general (teaching) hospitals or university precincts. Architectural decisions operating at the hospital scale include considerations of how secure site boundaries are provided. How buildings are laid out on a site. And how spatial and functional links are set up between those buildings.

This is important relative to the movement of patients and staff across a site, including the location and functionality of therapeutic hubs. But it can also impact patient and community psychology. The design of external fences, in particular, can compound feelings of confinement for patients. Focus community attention on the custodial role of a facility over and above its therapeutic function. And influence perceptions of safety and security for the community immediately surrounding the hospital.

Architectural decisions operating at the ‘individual’ scale are those that more closely impact the daily experience of a hospital for patients and staff. These include the various arrangements for inpatient accommodation. Tactics for providing patients with landscape access and views. And the question of staff spaces relative to safety, ease of communication and collaboration. Approaches to landscape, inpatient accommodation and concerns of staff supervision are closely intertwined.Findings.

What we learnt from 31 contemporary psychiatric hospital projectsForensic psychiatric hospitals treat patients who require mental health treatment in addition to a history of criminal offending or who are at risk of committing a criminal offence. Primarily, these include patients who are unfit to stand trial and those found not guilty on account of their illness.21 Accommodation is typically arranged according to low, medium or high security needs, alongside clinical need, and whether an acute, subacute, extended or translational rehabilitation setting is required. Security needs are determined based on the risk a patient presents to themselves and/or others, alongside their risk of absconding from the facility. The challenge that has proven intractable for centuries is how can architects balance privacy and dignity for patients, while maintaining supervision for their own safety, alongside that of their fellow patients, the staff providing care and, in some cases, the community beyond.22 In this section we present overall trends regarding the layout of buildings within hospital sites, including the placement of treatment hubs and the design of inpatient wards. Access to landscape is not explicitly addressed in this section but is implicit in decisions around site layout and inpatient accommodation.Design approaches to site layoutWe identified two approaches to site layout—the ‘village’ (4 from 31 hospitals) and the ‘campus’ (27 from 31 hospitals) (figure 1).

Similar in their functional arrangement, these are differentiated according to the degree of exterior circulation required to move between patient-occupied spaces. Village hospitals comprise a number of buildings sitting within the landscape, while campus hospitals have interconnected buildings with access provided by internal corridors that prevent the need to go outside. Neither approach is new. Both follow the models first used within the 19th century. The village hospital follows the model designed by Dr Albrecht Paetz in 1878 (Alt Scherbitz, Germany), which included detached cottages accommodating patients in groups of between 24 and 100, set within gardens.23 Paetz created this design in response to his belief that upwards of 1000 patients should not be accommodated in a single building, with security measures determined in relation to those patients whose behaviour was the least predictable.24 The resulting monotony of the daily routine and restrictions on patient movement were believed to ‘cripple the intelligence and depress the spirit’.25 Paetz’s model allowed doctors to classify patients into smaller groups and unlock doors to allow patients with predictable behaviour to wander freely within the secure outer boundaries of the hospital.26 This remained the preferred approach to patient accommodation for over a century, as endorsed by the WHO in their report of 1953.27 Broadmoor Hospital (UK, 2019) provides an example of the village model.The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub.

The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub." data-icon-position data-hide-link-title="0">Figure 1 The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub. The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub.The campus model is not dissimilar to the approach propagated by Dr Henry Thomas Kirkbride, a 19th-century psychiatrist who was active in the design of asylums and whose influence saw this planning arrangement dominate asylum constructions in the USA for many decades.28 Asylums of the ‘Kirkbride plan’ arranged patient accommodation in a series of pavilions linked by corridors. While corridors can be heavily glazed, where this action is not taken, the campus approach can compromise patient and staff connections to landscape views. Examples of campus hospitals include the Worcester Recovery Center and Hospital (USA, 2012) and the Nixon Forensic Center (USA, under construction).Treatment hubs are a contemporary addition to forensic psychiatric hospitals. These cluster a range of shared patient spaces, including recreational, treatment and vocational training facilities, and thus drive patient movement around or through a hospital site.

Two different treatment hub arrangements are in use. €˜internal’ and ‘on-edge’. Those arranged internally typically place these functions at the heart of the campus and at a significant distance from the secure boundary line. Those arranged on-edge are placed at the far end of campus-model hospitals and, in the most extreme cases, occur adjacent to one of the site’s external boundaries (refer to Figure 1). Both arrangements aspire to make life within the hospital resemble life beyond the hospital as closely as possible, as the daily practice of walking from an accommodation area to a treatment hub mimics the practice of travelling from home to a place of work or study.With evidence mounting regarding the psychological benefits to patients of landscape access, it should not be assumed that the current preference for campus hospitals over the village model indicates ‘best practice’.

A campus arrangement offers security benefits for the movement of patients across a hospital site, while avoiding the associated risks of contraband concealed within landscaped spaces. However, the existence of village hospitals for forensic cohorts suggests it is possible to successfully manage these challenges. Why then do we see such a strong persistence of the campus hospital?. This preference may be driven by cultural expectations. From 24 forensic psychiatric hospitals surveyed, 10 were located within the USA and all employed the campus model.

Yet nine of those hospitals occupied rural sites where the village model could have been used, suggesting the influence of the Kirkbride plan prevails. The four village hospitals within the broader sample of 31, spanning forensic and non-forensic settings, all occurred within the UK3 and Ireland1. Paetz’s villa model had been the preferred approach to new constructions in these countries since its introduction at close of the 19th century.29 However, a look at UK hospitals in isolation revealed a more even spread of village and campus arrangements, with two of the four UK-based campus hospitals occupying constrained urban sites that required multi-story solutions. The village model would be inappropriate for achieving this as it does not lend well to urban locations where land availability is scarce.Design approaches to inpatient accommodationThree approaches to inpatient accommodation were identified. €˜peninsula’, ‘race-track’ and ‘courtyard’ (Figure 2).

The peninsula model is characterised by rows of inpatient wings, along a single-loaded or double-loaded corridor that stretches into the surrounding landscape. This typically enables an exterior view from all patient bedrooms and is not dissimilar to the traditional ‘pavilion’ model that emerged within 19th-century hospital design.30 In the racetrack model bedrooms are arranged around a cluster of staff-only (or service) spaces, still enabling exterior views from all patient bedrooms. The courtyard model is similar to the racetrack but includes a central landscape space. Information on the design of inpatient room layouts was available for 24 of the 31 projects analysed (15 of these 24 were forensic).Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey." data-icon-position data-hide-link-title="0">Figure 2 Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey.Ten forensic hospitals employed a peninsula plan and five employed a courtyard plan. Of the non-forensic psychiatric hospitals five employed the courtyard, three the racetrack and only one the peninsula plan.

While the sample size is too small to generalise, the peninsula plan appears to be favoured for a forensic cohort. However, cultural trends again emerge. Of the 10 peninsula plan hospitals, 6 were located within the USA, and among the broader sample of 24 (including the non-forensic facilities) none of the courtyard hospitals were located there. Courtyard layouts for forensic patients occurred within the UK, Ireland, Denmark and Sweden. However, within these countries, a mix of courtyard and peninsula plans were used, suggesting no clear preference for one plan over the other.Each plan type has advantages and disadvantages (Table 2).

Courtyard accommodation provides the following benefits. Greater opportunity for patient access to landscape since these are easier for staff to maintain surveillance over. Additional safety for staff owing to continuous circulation (staff cannot get caught in ‘dead-ends’. However, the presence of corners which are difficult to see around is a drawback). Natural light is more easily available.

And ‘swing bedrooms’ can be supported (this is the ability to reconfigure the number of observable bedrooms on a nursing ward by opening and closing doors at different points within a corridor). However, courtyard accommodation requires a larger site area so is better suited to rural locations than urban and is not well suited to multi-story facilities. Peninsula accommodation enables geographical separation, giving medical teams greater opportunity to manage which patients are housed together (‘cohorting’). Blind corners can be avoided to assist safety and surveillance. Travel distances can be minimised.

Finally, the absence of continuous circulation provides greater flexibility for creating social spaces for patients with graduated degrees of (semi-)privacy.View this table:Table 2 Advantages and disadvantages of peninsula versus courtyard accommodationAnother important consideration related to inpatient accommodation is ward size. The number of bedrooms clustered together, alongside the amount of dedicated living space associated with these bedrooms. Ward size can influence patient agitation and aggression, alongside ease of supervision, staff anxiety and safety.31 The most common ward sizes were 24 or 32 beds, further subdivided into subclusters of 8 beds. Typically, each ward was provided with one large living space that all 24 or 32 patients used together. More advanced approaches gave patients a choice of living spaces.

For example, at Coalinga Hospital, patients could occupy a small living space available to only 8 patients, or a larger space that all 24 patients had access to. We describe this approach as more advanced since both 19th-century understandings alongside recent research by Ulrich et al confirm that social density (the number of persons per room) is ‘the most consistently important variable for predicting crowding stress and aggressive behaviour’.32 Only six hospitals had plans detailed enough to calculate the square-metre provision of living space per patient, and this varied between 5 and 8 square metres.Limitations of the desktop surveyData from a desktop survey are insufficient to obtain a comprehensive understanding of how design contributes to patient experience. To overcome this limitation, the following sections combine knowledge about how people use space from environmental psychology, knowledge about the design and consultation processes that guide the construction of these facilities, and understandings from architectural history. History suggests that seemingly small changes to typical design practice can effect significant change in the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. This integrated approach is used to identify three forensic psychiatric hospitals that challenge accepted design practice to varying degrees and, in doing so, have the potential to act as change-agents in the delivery of forensic mental healthcare.

But first it is important to understand the context in which architectural innovation is able, or unable, to emerge relative to forensic mental healthcare.Accepting the challenge. Using history to help us see beyond the roadblocks to innovationArchitects tasked with designing forensic mental health facilities respond to what is called a ‘functional brief’. This documents the specific performance requirements of the hospital in question. Much consultation goes into formulating and refining a functional brief through the initial and developed design stages. Consultation is typically undertaken with a variety of different user groups, and in a sequential fashion that includes a greater cross-section of users as the design progresses, including patients, families, and clinical and security staff.

Despite the focus on patient experience within contemporary models of care, functional briefs tend to prioritise safety and security, making them the basis on which most major architectural decisions are made.33 In large part this is simply the reality of accommodating a patient cohort who pose a risk of harm towards themselves and/or others. A comment from Tom Brooks-Pilling, a member of the design team for the Nixon Forensic Center (Fulton, Missouri), provides insight into this approach and the concerns that drive it. He explained that borrowing a ‘spoked wheel’ arrangement from prison design eliminated blind spots and hiding places to enable a centrally located staff member to:see everything that’s going on in that unit…[they are] basically watching the other staff’s back [sic] to make sure that they can focus on treatment and not worry about who might be sneaking up on them or what activities might be going on behind their backs.34Advisory panel feedback confirmed that when the architectural design of a facility heightens staff anxiety this has direct ramifications for the therapeutic process. For example, in spaces where staff could become isolated from one another, and where clear lines of sight were obstructed, such as ill-designed elevators or stairwells, this can lead to movement being reduced across the patient cohort to avoid putting staff in those spaces where they feel unsafe.The architects consulted during the course of this research, including those who were part of the research team, articulated how the necessary prioritisation of safety, in turn, leads to compromises in the attainment of an ideal environment to support treatment. In the various forensic and acute psychiatric hospital projects they had been involved with, all observed a sincere commitment on the part of those engaged in project briefing to upholding ideals around privacy, dignity, autonomy and freedom of movement for patients.

They reported, however, that the commitment to these ideals was increasingly obstructed as the design process progressed by the more pressing concerns of safety. Examples of the kinds of architectural implications of this prioritisation are things like spatially separated nursing stations (enclosed, often fully glazed), when a desire for less-hierarchical interactions between patients and staff had been expressed at the beginning of the briefing process. Or the substitution of harder-wearing materials, with a more ‘institutional’ feel when a ‘home-like’ atmosphere had been prioritised initially. There is nothing surprising or unusual about this process since design is, by its nature, a process of seeking improvements on accepted practice while systematically checking the suitability of proposed solutions against a set of performance requirements. In the context of forensic psychiatric hospitals, safety is the performance requirement that most often frustrates the implementation of innovative design.

Thus, amid the complexities of design and procurement relative to forensic psychiatric hospitals, innovation, however humble, and particularly where it can be seen to contribute positively to the patient experience, is worth a closer look.In the historical development of the psychiatric hospital as a building type, two significant departures from accepted design practice facilitated positive change in the treatment of mental illness. The first was Paetz’s development of the village hospital which sought to replace high fences, locked doors and barred windows with ‘humane but stringent supervision’.35 While this planning approach may not have significantly altered models of care, it was regarded as ‘an essential, vital development’, providing architectural support to the prevailing approach to treatment of the time—that of moral treatment—which aimed to extend kindness and respect to patients, in an environment that was as unrestrictive as possible. The York Retreat is worthy of acknowledgement here as a leading proponent of moral treatment whose influence shifted approaches to asylum design, from focusing on the provision of safe custody to supporting the restoration of sanity. Architecturally, however, the differences in the York Retreat’s approach were mainly focused on interior details that encouraged patients to maintain civil habits. Dining rooms had white tablecloths and flower vases adorned mantelpieces, door locks were custom-made to close quietly, and window bars fashioned to look like domestic window frames.36 The York Retreat was originally a small institution, in line with Samuel Tuke’s preference for a maximum asylum size of 30 patients.

History confirms the extent to which this approach was not scalable and thus unable to be replicated widely for asylum construction. For these reasons, it has not been considered here as a significant departure from accepted design practice.The second significant departure from accepted design practice was the development of acute treatment hospitals, located within cities, adjacent to general hospitals and medical research facilities. The first hospital of this type was the Maudsley Hospital, led by doctors Henry Maudsley and Frederick Mott, in London. The design intent for this hospital was announced in 1908 but it was not opened until 1923.37 In proposing this hospital, Maudsley and Mott were motivated to bring psychiatry ‘into line with the other branches of medical science’.38 This 100-bed facility, located directly across the road from the King’s College (Teaching) Hospital, emulated the general hospital typology in offering both outpatient and short-duration inpatient care, specifically targeted at patients with recent-onset illnesses. The aspirations were threefold.

To avoid the stigma associated with large public asylums. To advance the medical understanding of mental illness through research collaborations with general hospitals and medical schools and via improved teaching programmes. And to both enable and encourage patients to access early, voluntary treatment on an outpatient basis.38 Today the Maudsley appears unremarkable, an unassuming three-storied building on a busy London street. But the significance of what this building communicated at the time it was constructed, and the extent to which it challenged accepted practice, should not be underestimated. The Maudsley sent a clear message to the public that mental illness was no longer to be regarded as different from any other illness treated within a general hospital setting.

That it was no longer okay to isolate those suffering from mental illness from their families or the neighbourhoods in which they lived.39 Following the announcement of the Maudsley, the ‘psychopathic hospital’ rose to prominence within the USA with Johns Hopkins University Hospital opening the Phipps Psychiatric Clinic, in Baltimore, in 1913. The psychopathic hospital similarly promoted urban locations and closer connections to teaching and research. The Maudsley can be seen to have played a significant role in the shift to treating acute mental illness within general hospital settings.In any discussion of the history of institutional care, there is a responsibility to acknowledge that the aspiration to provide buildings that support care and recovery have not always manifested in ways that improved daily life for patients. The five treatment values that underpinned the analysis framework for this project are not new values. The extension of privacy and dignity to patients and the delivery of care within the least restrictive environment possible were both firmly embedded in the 19th-century approach of moral treatment.

Yet the rapid growth of asylum care frustrated the delivery of those values to patients.40 Choice and independence for patients, the desire for a patient’s recovery progress to be reflected in their environment, and opportunities for peer support and family involvement have been present in approaches to mental health treatment since the formal endorsement of the ‘therapeutic community’ approach to hospital construction and administration in the WHO’s report of 1953.41 History reminds us, therefore, that differences can arise between the stated values on which an institution is designed and those which it is constructed and operated. The three hospitals discussed in the following section include innovative solutions that hold the promise of positive benefits for patients. Yet we acknowledge this a theoretical analysis. For concrete evidence of a positive relationship between these design outcomes and patient well-being, postoccupancy evaluations are required.Three hospitals contributing to positive change in forensic mental healthcareBroadmoor Hospital. Optimising the value of the village model for patientsNineteenth-century beliefs and contemporary research are in accord regarding the importance of greenspace in reducing agitation within forensic psychiatric hospital environments and in promoting positive patterns of socialisation.42 It is surprising, therefore, that enshrining daily landscape access for patients is not widespread within current design practice.

The Irish National Forensic Mental Hospital and the State Hospital at Carstairs (Scotland) both follow the model of the village hospital, but only in that they comprise a number of accommodation buildings set within the landscape, enclosed by an external boundary fence. At the Irish National Forensic Mental Hospital, the scale of the landscape—the distance between buildings and the lack of intermediate boundaries within the landscape—suggests it is highly unlikely that patients are allowed to navigate this landscape on a regular basis. By comparison, the architectural response developed for Broadmoor Hospital (2019) shows an exemplary commitment to patient views and access to landscape (Figure 3).Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK)." data-icon-position data-hide-link-title="0">Figure 3 Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK).Five contemporary hospitals follow the logic of a traditional villa hospital, yet Broadmoor is the only one that optimises the benefits offered by this spatial configuration.

Comprising a gateway building and a central treatment hub, with a series of patient accommodation buildings positioned around it, the landscape becomes the only available circulation route for patients travelling off-ward to the shared therapy, recreation and vocational training spaces. Most patients will thus engage with the outdoors at least twice daily on their way to and return from these shared spaces. But in addition to accessing this central landscape, landscape views from patient rooms have been prioritised, and each ward is allocated its own large greenspace. Multiple, internal boundary fences enable patient access to the adjacent landscape to the greatest possible degree (refer to Figure 3). This approach provides patients with a diversity of landscape experiences.

This is important given the patterns of landscape use between forensic and non-forensic hospitals. In non-forensic facilities, patients are likely to have the choice of accessing multiple landscape spaces, whereas in forensic facilities access to a particular space is often restricted to one cohort, for example, a single ward group. This highlights a limitation of the courtyard model for forensic patients. Roseberry Park Hospital (2012) provides an example of how a high degree of landscape access can be similarly achieved for patients on constrained urban site, using a courtyard layout (refer to Figure 3).Providing patients with daily landscape access provides challenges to maintaining safety and security. Trees with low branches can be used as weapons, while tall branches can be used for self-harm, and ground cover landscaping increases opportunities to conceal contraband.

At the Australian hospital where advisory panel sessions were conducted (constructed in 2000), the landscape is occupied in a similar way and staff conveyed the constant effort required to ensure safe patient access to this greenspace. Significant costs are incurred annually by facilities staff in keeping the greenspace free from contraband and from several varieties of wild mushroom that grow seasonally on the site. Despite this cost, staff reported that both they and the patients value the opportunity to circulate through the landscaped grounds (even in inclement weather). Hence, the benefits to well-being are perceived as significant enough to justify this cost. These examples make evident that placing a hospital within a landscape is not enough to ensure patients are extended the well-being benefits of ongoing access.

Instead this requires that hospitals factor in the additional supervisory and maintenance requirements to maintain landscape access for patients.Worcester Recovery Center and Hospital. Spaces to support choice and a sense of controlResearch in environmental psychology, conducted within residential and hospital settings, confirms that the ability to regulate social contact can have a dramatic impact on well-being. The physical layout of spaces has been linked to both the likelihood of developing socially supportive relationships and impeding this development, with direct implications for communication, concentration, aggression and a person’s resilience to irritation.43 These problems can be more pronounced in a forensic psychiatric hospital as there is an over-representation of patients who have suffered trauma. Architects working in forensic psychiatric hospital design acknowledge that patients need space to withdraw from the busy hospital environment, spaces where they can ‘observe everything that is going on around them until they feel ready to join in’.44 It is surprising, therefore, that many contemporary forensic psychiatric hospitals still continue to provide a single social space for all 24 or 32 patients occupying a ward. The Worcester Recovery Center, by comparison, provides patients with a choice of social spaces that are designed to enable graduated degrees of social engagement.

This can support a sense of control to limit socially induced stress.Worcester is conceptualised as three distinct zones designed to resemble life beyond the hospital. The ‘house’, ‘neighbourhood’ and ‘downtown’ (Figure 4). The house zones include patient accommodation, employing a peninsula model. Each comprises 26 patient rooms, clustered into groups of 6 or 10 single bedrooms that face a collection of shared spaces dedicated to that cluster, including sitting areas, lounges and therapeutic spaces. A shared kitchen and dining room is provided for each house.

Three houses feed into a neighbourhood zone that includes shared spaces for therapy and vocational training, while the downtown zone serves a total of 14 houses. The downtown zone can be accessed by patients based on a merit system and includes a café, bank and retail spaces, music room, health club, chapel, green house, library and art rooms, alongside large interior public spaces. This array of amenities does not seem distinctly different from other contemporary facilities, where therapy and vocational training happen in a mix of on-ward and off-ward (often within a central treatment hub). The difference lies in the sensitivity of how these spaces are articulated.Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’." data-icon-position data-hide-link-title="0">Figure 4 Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’.The generosity of providing separate living spaces for every 6–10 patients and locating these directly across the corridor from the patient rooms supports a sense of control and choice for patients. Frank Pitts, an architect who worked on the Worcester project, has written that this was done to enable patients to ‘decide whether they are ready to step out and socialise or return to the privacy of their room’.45 This approach filters throughout the facility, providing a slow graduation of social engagement opportunities for patients, from opportunities to socialise with their cluster of 6–10 individuals, to their house of 26, to their neighbourhood of 78 people, to the full downtown experience.

According to the architects, the neighbourhood thus provides an intermediary zone between the quiet house and the active downtown, which can be overwhelming for some patients.46 Importantly the scale of the architecture responds to this transition from personal to public space, providing visual indicators to reflect patients’ movement through their treatment journey. Spaces become larger as they move further from the ward. This occurs because instead of providing a single, large shared living space, patients are provided a choice of smaller spaces to occupy—these are not much bigger than a patient bedroom. Dining spaces are slightly larger, while downtown spaces have a civic quality. These are double-height, providing a greater sense of light and airiness.

These are arranged in a semicircle, opening onto a large veranda and greenspace. The sensitive articulation of these spaces, with regard to both their graduated physical scale and the proximity of the social spaces to the patient bedrooms, provides spatial support to these social transitions while empowering patients to control their own level of social interaction.Margaret and Charles Juravinski Centre for Integrated Healthcare. Creating opportunities for greater public engagement and supporting readjustment to the world beyond the hospitalOne of the most significant barriers to mental health treatment is the stigma associated with admission to a psychiatric hospital. We know that discrimination poses an obstacle to recovery and that the media fuels public fears related to forensic mental health patients.47 Two further challenges to mental health delivery include the disconnection patients can experience from the community, including from family and educational opportunities, and the risk of readmission in the period immediately following discharge.48 If architecture is capable of acting as a change-agent in the delivery of mental healthcare, then it needs to show leadership, not only in the provision of a better experience for patients but more broadly in taking steps to help shift public perceptions around mental illness. The Margaret and Charles Juravinski Centre for Integrated Healthcare (MCJC) (Canada) displays several similarities with the approach taken to the Maudsley Hospital.

Its appearance communicates a modern, cutting-edge healthcare facility. It does not hide on a rural site or behind walls. At five stories, and extensively glazed, MCJC communicates a strong civic presence. Its proximity to McMaster University (6 km) and to neighbouring general hospitals, including Juravinski Hospital (4 km) and Hamilton General Hospital (4 km), positions it well for research collaborations to occur, while its proximity to the Mohawk Community College, across the road, can enable patients with leave privileges to access vocational training. More importantly, it employs three innovative design tactics to target the challenges of contemporary forensic mental healthcare, providing an example for how architecture might broker positive change.The first innovative design strategy is the co-location of support services for outpatient mental healthcare.

The risk of readmission is highest immediately following discharge. A lack of collaboration between outpatient support services can result in fragmented care when patients are most vulnerable to the stresses associated with readjustment to the world beyond.49 MCJC includes outpatient facilities allowing patients to use the hospital as a stable base, or touchstone, in adjusting to life after discharge. Bringing these services onto the same physical site can also improve opportunities for coordination between inpatient and outpatient support services which can support continuity of care. The second design strategy is the co-location of a medical ambulatory care centre which includes diagnostic imaging, educational and research facilities. This creates reasons for the general public to visit this facility, setting up the opportunity for greater public interaction.

This could potentially advance understandings of the role of this facility and the patients it treats.The third innovative design strategy was to optimise the on-edge treatment hub for public engagement. While adopted across a number of hospitals, including Hawaii State Hospital, Helix Forensic Psychiatry Clinic (Sweden) and the Worcester Recovery Center, the on-edge treatment hubs at these hospitals are buried deep inside the secure outer boundary. At MCJC, the treatment hub is placed adjacent to the public zones of the hospital—although on the second floor—and this can be viewed as extension of the public realm and enables the potential for the public to be brought right up to the secure boundary line (which occurs within the building). MCJC is divided into four zones. The public zone, the galleria (the name given to the treatment hub), the clinical corridor and inpatient accommodation (Figure 5).

The galleria functions similarly to the downtown at the Worcester Recovery Center. Patients are given graduated access to a series of spaces that support their recovery journey. These include a gym, wellness centre, spiritual centre, library, café, beauty salon, and retail and financial services, alongside patient and family support services. While the galleria was initially intended to be accessible by the general public, this was not immediately implemented on the facilities’ opening and it is unclear whether this has now occurred.50 Nonetheless, the potential for movement of patients outwards, and families inwards, has been built into the physical fabric of this building, meaning opportunities for social interaction and fostering greater public understanding are possible. If understanding is the antidote to discrimination, then exposing the public to the role of this facility and the patients it treats is an important step in the right direction.Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare.

The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated." data-icon-position data-hide-link-title="0">Figure 5 Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare. The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria.

Lifts (L) and stairwell (S) positions are indicated.ConclusionThe question of how architecture can support the therapeutic journey of forensic mental health patients is a critical one. Yet the availability of evidence-based design literature to guide designers cannot keep pace with growing global demand for new forensic psychiatric hospital facilities, while limitations remain relative to the breadth and usability of this research. A narrow view of what constitutes credible evidence can overlook the value of knowledge embedded in architectural practice, alongside that held by architectural historians and lessons from environmental psychology. In respect of such a pressing and important problem, there is a responsibility to integrate knowledge from across these disciplines. Accepting the limitations of a theoretical analysis and of the desktop survey method, we also argue for its value.

Architects learn through experience, across multiple projects. This gives weight to the value of examining existing, contemporary design solutions to identify architectural innovations capable of providing benefits to patients and thus perhaps worthy of implementation across multiple projects. History gives us reason to believe that small changes to typical design practice can improve the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. Architecture has the capacity to contribute to positive change.Here, we have provided a nuanced way for architects and decision makers to think about the relationship between architectural space and treatment values. An institution’s model of care and the therapeutic values that underpin that model of care should be placed at the centre of architectural decision making.

A survey of contemporary architectural solutions confirms that, generally speaking, innovation is lacking in this field. There will always be real obstacles to innovation, and the argument presented here does not suggest it is necessarily practical to prioritise therapeutic values at the cost of patient, staff and community safety. Instead, it challenges architects and decision makers to properly interrogate any architectural decision that compromises an initial commitment to supporting a patient’s treatment journey—to be more idealistic in the pursuit of positive change.Tangible examples exist of architectural innovations capable of positively improving patient experience by supporting key values that underpin contemporary treatment approaches. The Broadmoor Hospital optimises the value of the village model for patients, prioritising patient needs for frequent landscape engagement to support their therapeutic journey. The Worcester Recovery Center provides a generous choice and graduation of social spaces to support the social reintegration of patients at their own pace.

MCJC co-located facilities to support a patient’s readjustment to daily life postdischarge, while creating opportunities for public engagement that has the potential to foster greater public understanding of the role of these institutions and the patients they treat. In identifying these three innovative design approaches, we provide architects with tangible design tactics, while encouraging researchers to look more closely at these examples with targeted, postoccupancy studies. These projects provide hope that with a shared vision and commitment, innovation is possible in forensic psychiatric hospital design, with tangible benefits for patients.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary information. The primary method undertaken for this research relied on data publicly available on the internet.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsThe opportunity to conduct this project arose out of a multidisciplinary master-planning and feasibility study, commissioned by the Victorian Health and Human Services Building Authority, to investigate various international solutions to inform future planning and design around forensic mental health service provision. The following people contributed their time and expertise in shaping the research process that enabled this article.

Neel Charitra, Stefano Scalzo, Les Potter, Margaret Grigg, Lousie Bawden, Matthew Balaam, Martin Gilbert, John MacAllister, Crystal James, Jo Ryan, Julie Anderson, Jo Wasley, Sophie Patitsas, Meagan Thompson, Judith Hemsworth, James Watson, Viviana Lazzarini, Krysti Henderson, Nadia Jaworski, Jack Kerlin and Jan Merchant.Notes1. Jamie O'Donahoo and Janette Graetz Simmonds (2016), “Forensic Patients and Forensic Mental Health in Victoria. Legal Context, Clinical Pathways, and Practice Challenges,” Australian Social Work 69, no. 2. 169–80.2.

The challenge of which terminology to select when writing about psychiatric hospital design remains difficult relative to the stigmas that surround this field. The term ‘patient’ has been used throughout, instead of ‘consumer’, as this article spans both historical and contemporary developments. In the context of this timespan, consumer is a relatively recent term, introduced around 1985.3. B Edginton (1994), “The Well-Ordered Body. The Quest for Sanity through Nineteenth-Century Asylum Architecture,” Canadian Bulletin of Medical History 11, no.

2. 375–86. Clare Hickman (2009), “Cheerful Prospects and Tranquil Restoration. The Visual Experience of Landscape as Part of the Therapeutic Regime of the British Asylum, 1800-60,” History of Psychiatry 20, no. 4 Pt 4.

425–41. Rebecca McLaughlan, 2012), “Post-Rationalisation and Misunderstanding. Mental Hospital Architecture in the New Zealand Media,” Fabrications 22, no. 2. 232–56.4.

Roger S Ulrich et al. (2008), “A Review of the Research Literature on Evidence-Based Healthcare Design,” HERD 1, no. 3. 61–125. Jill Maben et al.

(2015), “Evaluating a Major Innovation in Hospital Design. Workforce Implications and Impact on Patient and Staff Experiences of All Single Room Hospital Accommodation,” Health Services and Delivery Research 3. 1–304. Penny Curtis and Andy Northcott (2017), “The Impact of Single and Shared Rooms on Family-Centred Care in Children’s Hospitals,” Journal of Clinical Nursing 26, no. 11–12.

1584–96.5. Roger S. Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” Journal of Environmental Psychology 57. 53–66.6.

Graham A Tyson, Gordon Lambert, and Lyn Beattie (2002), “The Impact of Ward Design on the Behaviour, Occupational Satisfaction and Well-Being of Psychiatric Nurses,” International Journal of Mental Health Nursing 11, no. 2. 94–102.7. For further examples of this see Jon E. Eggert et al.

(2014), “Person-Environment Interaction in a New Secure Forensic State Psychiatric Hospital,” Behavioral Sciences &. The Law 32, no. 4. 527–38. C.C.

Whitehead et al. (1984), “Objective and Subjective Evaluation of Psychiatric Ward Redesign,” The American Journal of Psychiatry 141, no. 5. 639–44. Gabriela Novotná et al.

(2011), “Client-Centered Design of Residential Addiction and Mental Health Care Facilities. Staff Perceptions of Their Work Environment,” Qualitative Health Research 21, no. 11. 1527–38.8. Morgan Andersson et al.

(2013), “New Swedish Forensic Psychiatric Facilities. Visions and Outcomes,” Facilities 31, no 1/2. 24–88.9. For examples see Kathleen Connellan et al. (2013), “Stressed Spaces.

Mental Health and Architecture,” HERD. Health Environments Research &. Design Journal 6, no. 4. 127–168.

Constantina Papoulias et al. (2014), “The Psychiatric Ward as a Therapeutic Space. Systematic Review,” British Journal of Psychiatry 205, no. 3. 171–6.10.

R. Allen and R.G. Nairn, 1997. Alan Dilani, 2000, “Psychosocially Supportive Design - Scandinavian Health Care Design,” World Hospitals and Health Services 37. 20–4.

Rebecca McLaughlan (2018), “Psychosocially Supportive Design. The Case for Greater Attention to Social Space within the Pediatric Hospital," HERD 11, no. 2. 151–62.11. Rebecca McLaughlan (2017), “Learning From Evidence-Based Medicine.

Exclusions and Opportunities within Health Care Environments Research,” Design for Health 1. 210–28.12. B Edginton (1997), “Moral Architecture. The Influence of the York Retreat on Asylum Design,” Health &. Place 3, no.

2. 91–9. Jeremy Taylor (1991), Hospital and Asylum Architecture in England 1849–1914. Building for Health Care (London. Mansell Publishing Limited).

Anne Digby (1985), Madness, Morality and Medicine. A Study of the York Retreat 1796–1914 (New York. Cambridge University Press).13. Digby, Madness, Morality and Medicine. Erving Goffman (1961), Asylums.

Essays on the Social Situation of Mental Patients and Other Inmates (New York. Doubleday). Ivan Belknap (1956), Human Problems of a State Mental Hospital (New York. Blakiston Division, McGraw-Hill). Andrew Scull (1979), Museums of Madness.

The Social Organization of Insanity in 19th Century England (London. Allen Lane). Leonard Smith (1999), Cure, Comfort and Safe Custody. Public Lunatic Asylums in Early Nineteenth-Century England (London. Leicester University Press).

Rebecca McLaughlan (2014), “One Dose of Architecture, Taken Daily. Building for Mental Health in New Zealand” (PhD diss., Victoria University of Wellington, New Zealand).14. Although not fitting a strict definition of postoccupancy evaluation, the following articles were notable exceptions to this finding. Eggert et al., “Person-Environment Interaction,” 527–38. Roger S.

Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. Catherine Clark Ahern et al. (2016), “A Recovery-Oriented Care Approach. Weighing the Pros and Cons of a Newly Built Mental Health Facility,” Journal of Psychosocial Nursing and Mental Health Services 54, no.

2. 39–48.15. M Gibbons (2000), “Mode 2 Society and the Emergence of Context-Sensitive Science,” Science and Public Policy 27. 161.16. D Seamon, 2000, “A Way of Seeing People and Place,” in Theoretical Perspectives in Environment-Behavior Research, ed.

S. Wapner, J. Demick, T. Yamamoto and H. Minami (New York.

Plenum), 157–78.17. Thomas A Markus (1982), Order in Space and Society. Architectural Form and Its Context in the Scottish Enlightenment (Edinburgh. Mainstream Publishing Company).18. Ulrich et al., “A Review of the Research Literature,” 61–125.19.

This was first created by first author for use for historical analysis during her PhD and is applied here to a contemporary setting. Refer to McLaughlan, “One Dose of Architecture, Taken Daily.”20. The following documents were referenced in compiling this list. Joint Commission Panel for Mental Health, NHS, UK (2013), “Guidance for Commissioners of Forensic Mental Health Services,” May, https://www.jcpmh.info/resource/guidance-for-commissioners-of-forensic-mental-health-services/. Cannon Design (2014), “St Joseph’s Integrated Healthcare Hamilton, Margaret and Charles Juravinski Centre for Integrated Healthcare,” Healthcare Design Showcase, September.

Health Nexus Group, 2017, “Forensicare Model of Care Report,” April, Australia (access provided by the Victorian Health and Human Services Building Authority). Donald Cant Watts Corke (2014), “Service Plan for Forensic Mental Health Services,” July, Australia (access provided by the Victorian Health and Human Services Building Authority).21. Sometimes this includes patients with no history of criminal behaviour but who are unable to be treated safely in a general hospital environment.22. W.A.F Browne (1991), "What Asylums Were, Are and Ought to Be (1837),” reprinted in The Asylum as Utopia. W.A.F.

Browne and the Mid-Nineteenth Century Consolidation of Psychiatry, ed. Andrew Scull (London. Tavistock). Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38.

Eggert et al., “Person-Environment Interaction.”23. Anon (1895), “Review. The Colonization of the Insane in Connection with the Open-Door System. Its Historical Development and the Mode in Which It Is Carried Out at Alt Scherbitz Manor. By Dr.

Albrecht Paetz, Director of the Provincial Institution for the Insane (Berlin. Springer, 1983),” The Journal of Mental Science 41. 697–703.24. Theodore Gray (1958), The Very Error of the Moon (Ilfracombe &. Devon.

Arthur H. Stockwell Ltd), 64.25. John Galt (1854), “The Farm of St. Anne,” American Journal of Insanity II (1854). 352.26.

Galt, “The Farm of St. Anne,” 352.27. Martin James (1948), “Diagnostic Measures,” in Modern Trends in Psychological Medicine, ed. Noel Haris (London. Buttefwork &.

Co. Ltd), 146. World Health Organization (1953), The Community Mental Hospital. Third Report of the Expert Committee on Mental Health (Geneva. WHO).28.

Carla Yanni (2007), The Architecture of Madness. Insane Asylums in the United States. Minneapolis (London. University of Minnesota Press).29. Key British examples included the 1923 rebuild of London’s Bethlem Hospital which followed the villa model, alongside Shenley Park Mental Hospital (Middlesex County) and Barrow Mental Hospital (Somerset), both constructed in the early 1930s.30.

Taylor, Hospital and Asylum Architecture in England.31. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. O. Jenkins, S. Dye and C.

Foy (2015) (Oliver Jenkins et al., 2015), “A Study of Agitation, Conflict and Containment in Association With Change in Ward Physical Environment,” Journal of Psychiatric Intensive Care 11, no. 01. 27–35. M. Daffern, M.M.

Mayer, and T. Martin (2004), “Environmental Contributors to Aggression in Two Forensic Psychiatric Hospitals,” International Journal of Forensic Mental Health 3 no. 1. 105–114. Kathryn L.

Brooks et al. (1994), “Patient Overcrowding in Psychiatric Hospital Units. Effects on Seclusion and Restraint,” Administration and Policy in Mental Health 22, no. 2. 133–44.

T. T Palmstierna, B Huitfeldt, and B Wistedt (1991), “The Relationship of Crowding and Aggressive Behavior on a Psychiatric Intensive Care Unit,” Psychiatric Services 42, no. 12. 1237–40.32. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 57.

Charles Mercier (1894), Lunatic Asylums. Their Organisation and Management (London. Charles Griffin and Company), 135.33. Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38.

Joel A Dvoskin et al. (2002), “Architectural Design of a Secure Forensic State Psychiatric Hospital,” Behavioral Scients &. The Law, 20, no. 3. 481-493.

J. Enser and D. Maclnnes (1999), “The Relationship between Building Design and Escapes from Secure Units,” Journal of the Royal Society for the Promotion of Health 119, no. 3. 170–4.

Jon E. Eggert et al. (2014), “Person-Environment Interaction,” 527–38.34. Tom Brooks-Pilling cited in Mike Lear (2015), “Designer. New Fulton State Hospital Will Be Better, Safer,” Missourinet, January 5, https://www.missourinet.com/2015/01/05/designer-new-fulton-state-hospital-will-be-better-safer/35.

Leslie Topp (2007), “The Modern Mental Hospital in Late Nineteenth-Century Germany and Austria. Psychiatric Space and Images of Freedom and Control,” in Madness, Architecture and the Built Environment. Psychiatric Spaces in Historical Context, ed. Leslie Topp, James Moran and Jonathan Andrews (London and New York. Routledge), 244.36.

McLaughlan, “One Dose of Architecture, Taken Daily,” 35. Digby, Madness, Morality and Medicine.37. Anon (1908), “Proposed New Hospital for Mental Diseases,” The Lancet 171, no. 4410. 728–9.38.

Anon, “Proposed New Hospital for Mental Diseases.”39. McLaughlan, “One Dose of Architecture, Taken Daily.”40. Samuel Tuke (1964), “Description of the Retreat (1813),” reprinted in Description of the Retreat With an Introduction by Richard Hunter and Ida Macalpine (London. Dawsons of Paul Mall). Scull, Museums of Madness.

Digby, Madness, Morality and Medicine. Smith, Cure, Comfort and Safe Custody.41. World Health Organization (1953), The Community Mental Hospital. Also refer to T.F Main (1946), “The Hospital as a Therapeutic Institution”, Bulletin of the Menninger Clinic 10, no. 3.

66–71. David Clark (1965), “The Therapeutic Community Concept, Practice and Future,” The Journal of Mental Science 111. 947–54.42. Jolanda Maas et al. (2009), “Social Contacts as a Possible Mechanism behind the Relation between Green Space and Health,” Health &.

Place 15, no. 2. 586–95. Gayle Souter-Brown (2015), Landscape and Urban Design for Health and Well-Being. Using Healing, Sensory and Therapeutic Gardens (Oxon &.

New York. Routledge). Ulrich et al., “A Review of the Research Literature,” 61–125.43. Leon Festinger et al. (1950), Social Pressures in Informal Groups.

A Study of Human Factors in Housing, vol. 11 (New York. Harper Bros). David Halpern (1995), Mental Health and the Built Environment. More than Bricks and Mortar?.

(London. Taylor and Francis). A. Baum and G.E. Davis (1980), “Reducing the Stress of High-Density Living.

An Architectural Intervention,” Journal of Personality and Social Psychology 38, no. 3. 471–81. I. Altman and M.M.

Chemers (1984), Culture and Environment (Monterey, CA. Brooks &. Cole Publishing). Gary W Evans (2003), “The Built Environment and Mental Health,” Journal of Urban Health. Bulletin of the New York Academy of Medicine 80 no.

4. 536–55. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66.44. Stence Guldager cited in Troldtekt, “Innovative Architecture is Good for Mental Health,” https://www.troldtekt.com/News/Themes/Healing_architecture/Innovative_architecture_is_good_for_mental_health (accessed June 30, 2019). Clare Hickman and “Cheerful Prospects (2009).45.

Frank Pitts cited in Patricia Wen (2012), “For Mentally Ill, A Design Departure,” B News, August 16, https://www.boston.com/news/local-news/2012/08/16/for-mentally-ill-a-design-departure46. Ellenzweig with Architecture Plus, “Massachusetts Department of Mental Health, Worcester Recovery Center and Hospital – Worcester, MA,” Healthcare Design (2013), July 30, https://www.healthcaredesignmagazine.com/architecture/massachusetts-department-mental-health-worcester-recovery-center-and-hospital-worcester-ma/47. Sane Australia (2003), “A Life Without Stigma,” July 25, http://apo.org.au/resource/life-without-stigma. Otto F Wahl (2012), “Stigma as a Barrier to Recovery from Mental Illness,” Trends in Cognitive Sciences 16, no. 1.

9–10. New Zealand Ministry of Health and Health Promotion Agency (2014), “Like Minds, Like Mine National Plan 2014–2019. Programme to Increase Social Inclusion and Reduce Stigma and Discrimination for People with Experience of Mental Illness,” May 20, https://www.likeminds.org.nz/assets/National-Plans/like-minds-like-mine-national-plan-2014-2019-may14.pdf. G Moon (2000), “Risk and Protection. The Discourse of Confinement in Contemporary Mental Health Policy," Health &.

Nairn (1997), “Media Depictions of Mental Illness. An Analysis of the Use of Dangerousness,” Australian &. New Zealand Journal of Psychiatry 31, no. 3. 375–81.

Greg Philo et al. (1994), “The Impact of the Mass Media on Public Images of Mental Illness. Media Content and Audience Belief,” Health Education Journal 53, no. 3. 271–81.48.

G Moon (2000), “Risk and Protection,” 239–50. T.F Main (1948), “Rehabilitation and the Individual,” in Modern Trends in Psychological Medicine, ed. Noel Haris (London. Buttefwork &. Co.

Ltd). D.A Fuller, E. Sinclair, and J. Snook (2016), “Released, Relapsed, Rehospitalized. Length of Stay and Readmission Rates in State Hospitals.

A Comparative State Survey,” 2016, https://www.treatmentadvocacycenter.org/storage/documents/released-relapsed-rehospitalized.pdf. Leila Salem et al. (2015), “Supportive Housing and Forensic Patient Outcomes,” Law and Human Behavior 39, no. 3. 311.49.

National Institute for Health and Clinical Excellence, Manchester (2016), “Transition between Inpatient Mental Health Settings and Community or Care Home Settings. Guideline,” August, https://www.nice.org.uk/guidance/ng53/evidence/full-guideline-pdf-260695191750. Catherine Clark Ahern et al. (2016), “A Recovery-Oriented Care Approach,” 47..

"Geographies of power, legacies of mistrust. Colonial medicine in the global present." Historical Geography no. 34:26-48.2.

Bridget Pratt et al. (2018). "Exploring the ethics of global health research priority-setting." BMC Medical Ethics no.

Richard Horton (2013). "Offline. Is global health neocolonialist?.

10.1016/S0140-6736(13)62379-X4. Anonymous (2019). "Editorial.

Break with tradition. The World Health Organization’s decision about traditional Chinese medicine could backfire." Nature no. 570:5.5.

S. S Amrith (2006). Decolonizing international health.

India and Southeast Asia, 1930–65. London. Palgrave Macmillan.6.

Arturo Escobar and A Escobar (1984). "Discourse and power in development. Michel Foucault and the relevance of his work to the third world." Alternatives no.

10 (3):377-400. Doi. 10.1177/0304375484010003047.

UNDG (2013). A million voices. The world we want.

A sustainable future with dignity for all. New York, NY. United Nations Development Group.8.

WHO (2019). Speech by the Director-General. Transforming for impact 2019 (cited 10 March 2019).

Available from. Https://www.who.int/dg/speeches/detail/transforming-for-impact.9. R.

C Keller (2006). Geographies of power, legacies of mistrust. Colonial medicine in the global present.10.

Mishal S Khan et al. (2019). Durrance-Bagale, H.

Legido-Quigley "‘LMICs as reservoirs of AMR’. A comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan." Health Policy and Planning no. 34 (3):178–187.

Doi. 10.1093/heapol/czz02211. Clare I R Chandler (2019).

"Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure." Palgrave Communications no. 5 (1):53.

Doi. 10.1057/s41599-019-0263-412. In the area of antimicrobial use for human health, other problem areas include, for example, public hygiene and disease prevention, regulated access to medicines, disease diagnosis, or market conditions for the development of new antimicrobials.

The Review on Antimicrobial Resistance (2016). Tackling drug-resistant s globally. Final report and recommendations.

London. The UK Prime Minister, WHO (2015b). Global action plan on antimicrobial resistance.

Geneva. World Health Organization, Conan MacDougall and Ron E Polk (2005). "Antimicrobial stewardship programs in health care systems." Clinical Microbiology Reviews no.

18 (4):638-656. Doi. 10.1128/CMR.18.4.638-656.2005.13.

The Review on Antimicrobial Resistance. Tackling drug-resistant s globally. Final report and recommendations.14.

WHO, Global action plan on antimicrobial resistance.15. Maria R Gualano et al. (2015).

"General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis." Pharmacoepidemiology and Drug Safety no. 24 (1):2-10.

Radyowijati (2010). "Determinants of antimicrobial use. Poorly understood, poorly researched." In Antimicrobial resistance in developing countries, edited by Sosa, Byarugaba, Amábile-Cuevas, Hsueh, Kariuki and Okeke, 283-300.

New York, NY. Springer.17. These problems persist despite encouraging trends.

For example, the field is becoming increasingly multidisciplinary through the involvement of several United Nations agencies alongside WHO in governing AMR, and AMR policy narratives are slowly broadening the hitherto hyper-individualised and behaviour change focus of global action plans. Connor Rochford et al. (2018).

"Global governance of antimicrobial resistance." The Lancet no. 391 (10134):1976-1978. Doi.

10.1016/S0140-6736(18)31117-6, WHO, FAO, and OIE (2018). Monitoring global progress on addressing antimicrobial resistance. Analysis report of the second round of results of AMR country self-assessment survey 2018.

Geneva. World Health Organization, Food and Agriculture Organization of the United Nations and World Organisation for Animal Health (OIE), WHO (2017). Antimicrobial Resistance Behaviour Change first informal technical consultation, 6-7 November, 2017 Château de Penthes, Geneva.

Meeting Report. Geneva. World Health Organization, Elise Klein and China Mills (2017).

"Psy-expertise, therapeutic culture and the politics of the personal in development." Third World Quarterly no. 38 (9):1990-2008. Doi.

10.1080/01436597.2017.131927718. Emma R M Cohen et al. (2008).

"Public engagement on global health challenges." BMC Public Health no. 8 (168). Doi.

10.1186/1471-2458-8-16819. B Hamlyn et al. (2015).Factors affecting public engagement by researchers.

A study on behalf of a consortium of UK public research funders. London. TNS20.

Research Councils UK (2011) Concordat for engaging the public with research. Research Councils UK. Swindon.21.

Building an engaged future for UK higher education. Full report from the Engaged Futures consultation. Bristol.

National Co-ordinating Centre for Public Engagement.22. Also referred to as ‘community engagement’, ‘patient and public involvement’ (PPI) in research, or in some instances also as participatory research. S.

Staniszewska et al. (2017). "GRIPP2 reporting checklists.

Tools to improve reporting of patient and public involvement in research." Research Involvement and Engagement no. 3 (13). Doi.

10.1186/s40900-017-0062-2, Jo Brett et al. (2014). "Mapping the impact of patient and public involvement on health and social care research.

A systematic review." Health Expectations no. 17 (5):637-650. Doi.

10.1111/j.1369-7625.2012.00795.x, Paulina O Tindana et al. (2007). "Grand challenges in global health.

Community engagement in research in developing countries." PLOS Medicine no. 4 (e273). Doi.

10.1371/journal.pmed.0040273, F Darroch and A. Giles (2014). "Decolonizing health research.

Community-based participatory research and postcolonial feminist theory." Canadian Journal of Action Research no. 15 (3):22-36.23. J Redfern et al.

(2018). "Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event." FEMS Microbiology Letters no.

Victoria Jane Hume et al. (2018). "Biomedicine and the humanities.

Growing pains." Medical Humanities no. 44 (4):230-238. Doi.

10.1136/medhum-2018-01148125. Astrid Treffry-Goatley et al. (2018).

Ibid. "Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach." 239-246.

Doi. 10.1136/medhum-2018-01147426. L Jordanova (2014).

"Medicine and the visual arts." In Medicine, health and the arts. Approaches to medical humanities, edited by Bates, Bleakley and Goodman, 41-63. Abingdon.

Routledge.27. Angela Ross Perfetti (2018). "Fate and the clinic.

A multidisciplinary consideration of fatalism in health behaviour." Medical Humanities no. 44 (1):59-62. Doi.

10.1136/medhum-2017-01131928. Devan Stahl et al. (2016).

"Seeing illness in art and medicine. A patient and printmaker collaboration." Ibid. No.

42 (3):155-159. Doi. 10.1136/medhum-2015-01083829.

Jonatan Wistrand and J Wistrand (2017). "When doctors are patients. A narrative study of help-seeking behaviour among addicted physicians." Ibid.

Carson (2015). Medical humanities. An introduction.

New York, NY. Cambridge University Press.31. Daniel Holman and Erica Borgstrom (2016).

"Applying social theory to understand health-related behaviours." Medical Humanities no. 42 (2):143-145. Doi.

10.1136/medhum-2015-01068832. Hume, et al., Biomedicine and the humanities. Growing pains.33.

A Carusi (2016). "Modelling systems biomedicine. Intertwinement and the 'real'." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 50-65.

Edinburgh. Edinburgh University Press.34. Jordanova, Medicine and the visual arts.35.

Stahl and Stahl, Seeing illness in art and medicine. A patient and printmaker collaboration.36. William Viney et al.

(2015). "Critical medical humanities. Embracing entanglement, taking risks." Ibid.

10.1136/medhum-2015-01069237. J Cole and S. Gallagher (2016).

"Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. " In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 377-394.

Edinburgh. Edinburgh University Press.38. J Macnaughton and H.

Carel (2016). Ibid."Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap." In, 294-309.39.

P J Pelto and G H Pelto (1997). 1997. "Studying knowledge, culture, and behavior in applied medical anthropology." Medical Anthropology Quarterly no.

11 (2):147-163.40. Lindsay Prior (2003) "Belief, knowledge and expertise. The emergence of the lay expert in medical sociology." Sociology of Health &.

10.1111/1467-9566.0033941. E Oliveira and J. Vearey (2018).

"Making research and building knowledge with communities. Examining three participatory visual and narrative projects with migrants who sell sex in South Africa." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 265-287.

Cham. Springer.42. Komatra Chuengsatiansup and Wirun Limsawart (2019).

"Tuberculosis in the borderlands. Migrants, microbes and more-than-human borders." Palgrave Communications no. 5 (1):31.

Doi. 10.1057/s41599-019-0239-443. R Garden (2014).

"Social studies. The humanities, narrative, and the social context of the patient-professional relationship." In Health humanities reader, edited by Jones, Wear, Friedman and Pachucki, 127-137. New Brunswick, NJ.

Rutgers University Press.44. Holman and Borgstrom, Applying social theory to understand health-related behaviours.45. Claas Kirchhelle (2018).

"Pharming animals. A global history of antibiotics in food production (1935–2017)." Palgrave Communications no. 4 (96).

Doi. 10.1057/s41599-018-0152-246. Hannah Landecker (2019).

"Antimicrobials before antibiotics. War, peace, and disinfectants." Ibid. No.

Sue Walker (2019). Ibid."Effective antimicrobial resistance communication. The role of information design." 24.

Doi. 10.1057/s41599-019-0231-z48. Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.49.

May Sudhinaraset et al. (2013). "What is the role of informal healthcare providers in developing countries?.

A systematic review." PLoS ONE no. 8 (2):e54978. Doi.

10.1371/journal.pone.005497850. Viroj Tangcharoensathien, Sunicha Chanvatik, and Angkana Sommanustweechai (2018). "Complex determinants of inappropriate use of antibiotics." Bulletin of the World Health Organization no.

96 (2):141-144. Doi. 10.2471/BLT.17.19968751.

WHO (2015a). Antibiotic resistance. Multi-country public awareness survey.

Geneva. World Health Organization.52. WHO, Antibiotic resistance.

Multi-country public awareness survey, 42.53. Gualano, et al. General population's knowledge and attitudes about antibiotics.

A systematic review and meta-analysis.54. Edward A Belongia et al. (2002).

"Antibiotic use and upper respiratory s. A survey of knowledge, attitudes, and experience in Wisconsin and Minnesota." Preventive Medicine no. 34 (3):346-352.

Doi. 10.1006/pmed.2001.099255. Miao Yu et al.

(2014). "Knowledge, attitudes, and practices of parents in rural China on the use of antibiotics in children. A cross-sectional study." BMC Infectious Diseases no.

Abdelmoneim Ismail Awad and Esraa Abdulwahid Aboud (2015). "Knowledge, attitude and practice towards antibiotic use among the public in Kuwait." PLoS ONE no. 10 (2):e0117910.

Doi. 10.1371/journal.pone.011791057. Chandler, Current accounts of antimicrobial resistance.

Stabilisation, individualisation and antibiotics as infrastructure.58. Jie Chang et al. (2018).

"Non-prescription use of antibiotics among children in urban China. A cross-sectional survey of knowledge, attitudes, and practices." Expert Review of Anti-infective Therapy no. 16 (2):163-172.

Doi. 10.1080/14787210.2018.142561659. Gualano, et al.

General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis.60. A R McCullough et al.

(2016). "A systematic review of the public's knowledge and beliefs about antibiotic resistance." Journal of Antimicrobial Chemotherapy no. 71 (1):27-33.

Doi. 10.1093/jac/dkv31061. Abel Santiago Muri-Gama, Albert Figueras, and Silvia Regina Secoli (2018).

"Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin. We need to promote more rational use even in remote places." PLoS ONE no. 13 (e0201579).

Doi. 10.1371/journal.pone.020157962. A Launiala (2009).

"How much can a KAP survey tell us about people's knowledge, attitudes and practices?. Some observations from medical anthropology research on malaria in pregnancy in Malawi." Anthropology Matters no. 11 (1).63.

Achieving the balance between access and excess." The Lancet no. 387 (10014):102-104. Doi.

10.1016/S0140-6736(15)00729-164. C Olivier et al. (2010).

"Containing global antibiotic resistance. Ethical drug promotion in the developing world." In Antimicrobial resistance in developing countries, edited by Sosa, Byarugaba, Amábile-Cuevas, Hsueh, Kariuki and Okeke, 505-524. New York, NY.

Springer.65. Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure.66.

Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure.67. Steve Hinchliffe, Andrea Butcher, and Muhammad Meezanur Rahman (2018).

"The AMR problem. Demanding economies, biological margins, and co-producing alternative strategies." Ibid. No.

Chuengsatiansup and Limsawart, Tuberculosis in the borderlands. Migrants, microbes and more-than-human borders.69. Khan, et al, ‘LMICs as reservoirs of AMR’.

A comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan.70. Didier Wernli et al. (2017).

"Mapping global policy discourse on antimicrobial resistance." BMJ Global Health no. 2 (e000378). Doi.

10.1136/bmjgh-2017-00037871. Nancy J Hawkings, Fiona Wood, and Christopher C Butler (2007). "Public attitudes towards bacterial resistance.

A qualitative study." Journal of Antimicrobial Chemotherapy no. 59 (6):1155-1160. Doi.

10.1093/jac/dkm10372. McCullough, et al. A systematic review of the public's knowledge and beliefs about antibiotic resistance.73.

Muri-Gama, et al. Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin. We need to promote more rational use even in remote places.74.

David G Allison et al. (2017). "Antibiotic resistance awareness.

A public engagement approach for all pharmacists." International Journal of Pharmacy Practice no. 25 (1):93-96. Doi.

10.1111/ijpp.1228775. Mark Davis et al. (2018).

"Understanding media publics and the antimicrobial resistance crisis." Global Public Health no. 13 (9):1158-1168. Doi.

10.1080/17441692.2017.133624876. Simon J Howard et al. (2013).

"Antibiotic resistance. Global response needed." The Lancet Infectious Diseases no. 13 (12):1001-1003.

Doi. 10.1016/S1473-3099(13)70195-677. Renly Lim et al.

(2016). "Village drama against malaria." The Lancet no. 388 (10063):2990.

Doi. 10.1016/S0140-6736(16)32519-378. Deborah Nyirenda et al.

(2018). "Public engagement in Malawi through a health-talk radio programme ‘Umoyo nkukambirana’. A mixed-methods evaluation." Public Understanding of Science no.

27 (2):229-242. Doi. 10.1177/096366251665611079.

Redfern, et al. Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event.80.

Sungjong Roh et al. (2018). "Public understanding of One Health messages.

The role of temporal framing." Public Understanding of Science no. 27 (2):185-196. Doi.

10.1177/096366251667080581. Tindana, et al., Grand challenges in global health. Community engagement in research in developing countries.82.

Mpoe Johannah Keikelame and Leslie Swartz (2019). "Decolonising research methodologies. Lessons from a qualitative research project, Cape Town, South Africa." Global Health Action no.

12 (1):1561175. Doi. 10.1080/16549716.2018.156117583.

Keymanthri Moodley and Shenuka Singh (2016). "“It’s all about trust”. Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa." BMC Medical Ethics no.

Seye Abimbola (2020). "Beyond positive a priori bias. Reframing community engagement in LMICs (epub ahead of print)." Health Promotion International.

Doi. 10.1093/heapro/daz02385. Keikelame and Swartz, Decolonising research methodologies.

Lessons from a qualitative research project, Cape Town, South Africa.86. Kenneth M Boyd (2000). "Disease, illness, sickness, health, healing and wholeness.

Exploring some elusive concepts." Medical Humanities no. 26 (1):9-17. Doi.

10.1136/mh.26.1.987. Hume, et al., Biomedicine and the humanities. Growing pains.88.

I Bamforth (2000). "Kafka's uncle. Scenes from a world of trust infected by suspicion." Ibid.

10.1136/mh.26.2.8589. Wistrand, When doctors are patients. A narrative study of help-seeking behaviour among addicted physicians.90.

Garden, Social studies. The humanities, narrative, and the social context of the patient-professional relationship.91. A Harpin (2016).

"Broadmoor performed. A theatrical hospital." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 577-595. Edinburgh.

Edinburgh University Press.92. Jordanova, Medicine and the visual arts.93. Stahl and Stahl, Seeing illness in art and medicine.

A patient and printmaker collaboration.94. K G Sweeney et al. (2001).

"A comparison of professionals' and patients' understanding of asthma. Evidence of emerging dualities?. " Ibid.

10.1136/mh.27.1.2095. Treffry-Goatley, et al., Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.96.

An argument against competence." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 541-558. Edinburgh. Edinburgh University Press.97.

L Jerke, M. Prendergast, and W. Dobson (2018).

"Smoking cessation in mental health communities. A living newspaper applied theatre project." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 171-186.

A comparison of professionals' and patients' understanding of asthma. Evidence of emerging dualities?. 99.

S Switzer (2018). "What’s in an image?. Towards a critical and interdisciplinary reading of participatory visual methods." In Creating social change through creativity.

Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 189-207. Cham. Springer.100.

Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. , 378.101.

Cole, et al. Medical humanities. An introduction.102.

J Herman (2001). "Medicine. The science and the art." Medical Humanities no.

[Viney, et al. Critical medical humanities. Embracing entanglement, taking risks.104.

Design and methods. Thousand Oaks, CA. Sage.105.

L Gilman (2015). Illness and image. Case studies in the medical humanities.

HarbarthM Haughton (2018). Staging trauma. Bodies in shadow.

London. Palgrave Macmillan.108. S Hodge, J Robinson, and P Davis (2007).

"Reading between the lines. The experiences of taking part in a community reading project." Medical Humanities no. 33 (2):100-104.

Doi. 10.1136/jmh.2006.000256109. Hume, et al.

Biomedicine and the humanities. Growing pains.110. Saam Idelji-Tehrani and Muna Al-Jawad (2019).

"Exploring gendered leadership stereotypes in a shared leadership model in healthcare. A case study." Ibid. No.

45:388-398. Doi. 10.1136/medhum-2018-011517111.

Suze M P J Jans et al. (2012). "A case study of haemoglobinopathy screening in the Netherlands.

Witnessing the past, lessons for the future." Ethnicity &. Health no. 17 (3):217-239.

Doi. 10.1080/13557858.2011.604126112. Hume, et al., Biomedicine and the humanities.

Growing pains.113. Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?.

114. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.115.

Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.116. Prior, Belief, knowledge and expertise. The emergence of the lay expert in medical sociology.117.

Gilman, Illness and image. Case studies in the medical humanities.118. Cole and Gallagher, Narrative and clinical neuroscience.

Can phenomenologically informed approaches and empirical work cross-fertilise?. 119. Macnaughton and Carel, Breathing and breathlessness in clinic and culture.

Using critical medical humanities to bridge an epistemic gap.120. C Teddlie and A. Tashakkori (2009).

Foundations of mixed methods research. Integrating quantitative and qualitative approaches in the social and behavioral sciences. Thousand Oaks, CA.

Sage.121. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.122.

Gian Luca Barbieri et al. (2016). "Imagination in narrative medicine." Journal of Child Health Care no.

20 (4):419-427. Doi. 10.1177/1367493515625134123.

Treffry-Goatley, et al. Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.124.

WHO (2016). World Antibiotic Awareness Week. 2016 campaign toolkit.

Geneva. World Health Organization.125. Across the three villages, 67% of the workshop attendees were female and the average age of the attendees was 44 years (range.

18 to 81 years. Based on subsequently collected survey data).126. Nutcha Charoenboon et al.

(2019)127. We thank an anonymous reviewer for highlighting the potential hazards of reproducing hierarchies through methods intended to challenge them in the first place.128. The research was reviewed and approved by the University of Oxford Tropical Research Ethics Committee (Ref.

OxTREC 528-17), and it received local ethical approval in Thailand from the Mae Fah Luang University Research Ethics Committee on Human Research (Ref. REH 60099). The service evaluation of the photo exhibition involved anonymised data collection and received a waiver for ethical approval from the University of Warwick Humanities &.

Social Sciences Research Ethics Committee (HSSREC). However, all evaluation form respondents explicitly consented to the data being reported in research publications.129. Marco J Haenssgen et al.

(2018)130. National Statistical Office (2012). The 2010 population and housing census.

Changwat Chiang Rai. Bangkok. National Statistical Office.131.

Data on the individual level would entail duplication of observations should both census survey rounds be included. Step-level data were aggregated on the illness level for analysis.132. Claire Charlotte McKechnie (2014).

"Anxieties of communication. The limits of narrative in the medical humanities." Medical Humanities no. 40 (2):119-124.

Doi. 10.1136/medhum-2013-010466133. Carusi, Modelling systems biomedicine.

Intertwinement and the 'real'.134. Garden, Social studies. The humanities, narrative, and the social context of the patient-professional relationship.135.

Emma Sacks et al. (2018). "Beyond the building blocks.

Integrating community roles into health systems frameworks to achieve health for all." BMJ Global Health no. 3 (Suppl. 3):e001384.

Doi. 10.1136/bmjgh-2018-001384136. Sudhinaraset, et al.

What is the role of informal healthcare providers in developing countries?. A systematic review.137. G Bloom et al.

(2015). Addressing resistance to antibiotics in pluralistic health systems. Brighton.

University of Sussex138. WHO (2007). Strengthening health systems to improve health outcomes.

WHO’s framework for action. Geneva. World Health Organization.139.

Jordanova, Medicine and the visual arts.140. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.141.

A Bleakley (2014). Ibid. "Towards a 'critical medical humanities'." In, 17-26.142.

Hume, et al., Biomedicine and the humanities. Growing pains.143. Nutcha Charoenboon et al.

(2019)144. Marco Haenssgen et al. (2018)145.

WHO, World Antibiotic Awareness Week. 2016 campaign toolkit.146. The questionnaire did so by showing all survey respondents three images of common antibiotic capsules being used in Chiang Rai (green-blue.

White-blue. Azithromycin—see questionnaire page 10 in the online supplementary material). Respondents were asked to name what they saw, and all their answers were recorded (field-coded and as free text).147.

The ‘desirability’ of the responses was field coded by the survey team. Sample responses (as instructed through the survey manual) for ‘desirable’ answers included, for example, “Only if the doctor says that I should”. Sample responses for ‘undesirable’ answers included “Yes, you can buy it in the shop over there!.

€ The variable should be interpreted as ‘the fraction of respondents who uttered a ‘desirable’ response’—the inverse is the fraction of responses that could not be deemed ‘desirable’ (eg, ‘do not know’ or ‘no opinion’).148. Because recalled descriptions of medicine tend to be ambiguous, we limited our analysis to medicines where we had a high degree of certainty that they were an antibiotic. This was specifically the case if survey respondents mentioned common antibiotic descriptions such as ‘anti-inflammatory’, ‘amoxi’ or ‘colem’, if they indicated explicitly that they know what ‘anti-inflammatory medicine’ is (noting that the term describes antibiotics unambiguously in Thai), and if they subsequently mentioned any of the previously mentioned antibiotics during their description of an illness episode (conversely, we excluded cases were the medicine could not be confirmed as either antibiotic or non-antibiotic, including descriptions like ‘white powder’ or ‘green capsule’).149.

Aristotle (1954). Rhetoric. Translated by Roberts.

New York, NY. Modern Library. Original edition, 350 BC.150.

Arya Nielsen et al. (2007). "The effect of gua sha treatment on the microcirculation of surface tissue.

A pilot study in healthy subjects." EXPLORE no. 3 (5):456-466. Doi.

10.1016/j.explore.2007.06.001151. Nithima Sumpradit et al. (2012).

"Antibiotics Smart Use. A workable model for promoting the rational use of medicines in Thailand." Bulletin of the World Health Organization no. 90 (12):905-913.

Doi. 10.2471/BLT.12.105445152. C Muksong and K.

Chuengsatiansup (2020). Forthcoming. "Medicine and public health in Thai historiography.

From an elitist view to counter-hegemonic discourse." In Health, pluralism and globalisation. A modern history of medicine in South-East Asia, edited by Monnais and Cook. London.

The Wellcome Trust Centre for the History.153. L Sringernyuang (2000). Availability and use of medicines in rural Thailand.

Amsterdam. Amsterdam Institute for Social Science Research.154. Although this was not the focus of the current paper, we note for full disclosure that the workshops, too, had mixed behavioural impacts.

The poster making sessions in Chiang Rai demonstrated for instance how our conversations about drug resistance and the introduction of messages from the World Health Organization entailed at times problematic interpretations like, “You shouldn’t take medicines that you have never seen before”—the research team responded to such interpretations directly in order to avoid misunderstandings. In addition, previous behavioural analyses documented that, while workshop participants demonstrated higher levels of awareness of drug resistance, alignment of antibiotic use with global health recommendations was mixed, and in one case, a villager started selling antibiotics after the workshop. For more details on the behavioural analysis, see Nutcha Charoenboon et al.

(2019) and Marco Haenssgen et al. (2018).155. For example, Redfern, et al., Spreading the message of antimicrobial resistance.

A detailed account of a successful public engagement event.156. Antoine Boivin et al. (2018).

2018. "Patient and public engagement in research and health system decision making. A systematic review of evaluation tools (epub ahead of print)." Health Expectations.

Doi. 10.1111/hex.12804157. Staniszewska, et al.

GRIPP2 reporting checklists. Tools to improve reporting of patient and public involvement in research.158. Jerke, et al.

Smoking cessation in mental health communities. A living newspaper applied theatre project.159. Switzer, What’s in an image?.

Towards a critical and interdisciplinary reading of participatory visual methods.160. R. C Barfield and L.

Selman (2014). "Health and humanities. Spirituality and religion." In Health humanities reader, edited by Jones, Wear, Friedman and Pachucki, 376-386.

New Brunswick, NJ. Rutgers University Press.161. Abimbola, Beyond positive a priori bias.

Reframing community engagement in LMICs (epub ahead of print), 1.162. Marco J Haenssgen et al. (2019)163.

Marc Mendelson et al. (2017). "Antibiotic resistance has a language problem." Nature no.

Haak and Radyowijati, Determinants of antimicrobial use. Poorly understood, poorly researched.165. S Harbarth and D.

L. Monnet (2008). "Cultural and socioeconomic determinants of antibiotic use." In Antibiotic Policies.

Fighting Resistance, edited by Gould and van der Meer, 29-40. Boston, MA. Springer.166.

K Sirijoti, P. Havanond Hongsranagon, and W. Pannoi (2014).

"Assessment of knowledge attitudes and practices regarding antibiotic use in Trang province, Thailand." Journal of Health Research no. 28 (5):299-307.167. Ramona K C Finnie et al.

(2011). "Factors associated with patient and health care system delay in diagnosis and treatment for TB in sub-Saharan African countries with high burdens of TB and HIV." Tropical Medicine &. International Health no.

16 (4):394-411. Doi. 10.1111/j.1365-3156.2010.02718.x168.

Haak and Radyowijati, Determinants of antimicrobial use. Poorly understood, poorly researched.169. Chandler, Current accounts of antimicrobial resistance.

Stabilisation, individualisation and antibiotics as infrastructure, 5.170. S Willson and K. Miller (2014).

"Data collection." In Cognitive interviewing methodology. A sociological approach for survey question evaluation, edited by Miller, Willson, Chepp and Padilla, 15-34. Hoboken, NJ.

Wiley.171. See Linda Mayoux and Robert Chambers (2005). "Reversing the paradigm.

Quantification, participatory methods and pro-poor impact assessment." Journal of International Development no. 17 (2):271-298. Doi.

10.1002/jid.1214172. Howard S. Becker (1995).

"Visual sociology, documentary photography, and photojournalism. It's (almost) all a matter of context." Visual Sociology no. 10 (1-2):5-14.

Doi. 10.1080/14725869508583745173. J Prosser and D.

Schwartz (2005). "Photographs and the sociological research process." In Image-based research. A sourcebook for qualitative researchers, edited by Prosser, 101-115.

Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.175. Switzer, What’s in an image?.

Towards a critical and interdisciplinary reading of participatory visual methods.176. Hume, et al. Biomedicine and the humanities.

Growing pains.177. Jordanova, Medicine and the visual arts, 60.178. Bleakley, Towards a 'critical medical humanities'.179.

Nutcha Charoenboon et al. (2019)180. Hume, et al.

Biomedicine and the humanities. Growing pains.181. J.

P Ansloos (2018). €œTo speak in our own ways about the world, without shame”. Reflections on indigenous resurgence in anti-oppressive research.” In Creating social change through creativity.

Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 3-18. Cham. Springer.182.

Marco J Haenssgen (2019)183. Michael Etherton and Tim Prentki (2006). "Drama for change?.

Prove it!. Impact assessment in applied theatre." Research in Drama Education. The Journal of Applied Theatre and Performance no.

11 (2):139-155. Doi. 10.1080/13569780600670718184.

Susan Galloway (2009). "Theory-based evaluation and the social impact of the arts." Cultural Trends no. 18 (2):125-148.

Doi. 10.1080/09548960902826143185. Darquise Lafrenière and Susan M Cox (2013).

"‘If you can call it a poem’. Toward a framework for the assessment of arts-based works." Qualitative Research no. 13 (3):318-336.

Doi. 10.1177/1468794112446104IntroductionIn Australia, the USA and the UK, the number of hospital beds required for forensic mental health treatment doubled between 1996 and 2016.1 Current trends and future predictions suggest this demand will continue to grow. But, in an age where evidence-based practice is highly valued, the demand for new facilities already outpaces the availability of credible evidence to guide designers.

This article reports findings from a desktop survey of current design practice across 31 psychiatric hospitals (24 forensic, 7 non-forensic) constructed or scheduled for completion between 2006 and 2022. Desktop surveys, as a form of research, are heavily relied on in architectural practice. Photographs and architectural drawings are analysed to understand both typical and innovative approaches to designing a particular building type.

While desktop surveys are sometimes supplemented by visits to exemplar projects (which might also be termed ‘fieldwork’), time pressures and budgetary constraints often preclude this. As the result of an academic–industry partnership, the research reported herein embraced practice-based research methods in conjunction with an academic approach. The data set available for the desktop survey was rich but incomplete.

Security requirements restrict the public availability of complete floor plans and postoccupancy evaluations. To mitigate these limitations, knowledge was integrated from other disciplines, including environmental psychology, architectural history and professional practice. With regard to the latter, knowledge is specifically around the design and consultation processes that guide the construction of these facilities.

This knowledge was used to identify three contemporary hospitals that challenge accepted design practice and, we argue, in doing so have the potential to act as change-agents in the delivery of forensic mental healthcare. We define innovation as variation/s to common, or typical, architectural solutions that can positively improve patients’2 experience of these facilities in ways that directly support one, or a number, of key values underpinning forensic mental healthcare. While this article does not provide postoccupancy data to quantify the value of these innovations, we hope to encourage both designers and researchers to more closely consider these projects—particularly the way that spaces have been designed to benefit patient well-being—and the questions these designs raise for the future of forensic mental healthcare delivery.Now regarded as naïve is the 19th-century belief that architecture and landscape, if appropriately designed, can restore sanity.3 Yet contemporary research from the field of evidence-based design confirms that the built environment does play a role in the therapeutic process, even if that role does not determine therapeutic outcomes.4 Research regarding the design of forensic mental healthcare facilities remains limited.

An article by Ulrich et al recommended that to reduce aggression patients should be accommodated in single rooms. Communal areas should have movable furniture. Wards should be designed for low social densities.

And accessible gardens should be provided.5 An earlier study by Tyson et al showed that lower ward densities can also positively improve patient–staff interactions.6 Commonly, however, the studies referenced above compared older-style mental health units with their contemporary replacements.7 There is little comparative research available that examines contemporary facilities for forensic mental healthcare, with the exception of one article that provided a comparative analysis of nine Swedish facilities, designed between 1990 and 2008.8 However, this article merely described the design aspirations and physical composition of each hospital without investigating the link between design aspiration, patient well-being and the resulting physical environment.There are two further limitations to evidence-based design research. The first is the extent to which data do not provide directly applicable design tactics. Systematic literature reviews typically provide a set of design recommendations but without suggesting to designers what the corresponding physical design tactics to achieve those recommendations might actually be.9 This is consistent for general hospital design.

For example, architects have been advised to provide spaces that are ‘psychosocially supportive’ since 2000, yet it was 2016 before a spatially focused definition of this term was provided, offering designers a more tangible understanding of what they should be aiming for.10 The second limitation is the breadth of research currently available. While rigorous and valuable, evidence-based design often overlooks the fact that architects must design across scales, from the master-planning scale—deciding where to place buildings of various functions within a site, and how to manage the safe movement of staff and patients between those buildings—to the scale of a bathroom door. How do you design a bathroom door to meet antiligature and surveillance requirements, to maintain patient safety, while still communicating dignity and respect for patients?.

The available literature provides much to contemplate, but in terms of credible evidence much of this research is based on a single study, typically conducted within a single hospital context and often focused on a single aspect of design. This raises the question, is there really a compelling basis for regarding evidence-based design knowledge as more credible than knowledge generated about this building type from other disciplines?. In light of the small amount of evidence available in this field, is there not a responsibility to use all the available knowledge?.

While the discipline of evidence-based design has existed for three decades,11 purpose-designed buildings for the treatment of mental illness have been constructed for over three centuries. Researchers working within the field of architectural history also understand that patient experience is partially determined—for better or worse—by the decisions that designers make, and that models of care have been used to drive design outcomes since the establishment of the York Retreat in 1796. With their focus on moral treatment, the York Retreat influenced a shift in the way asylum design was approached, from the provision of safe custody to finding architectural solutions to support the restoration of sanity.12 Architectural historians also bring evidence to bear in respect of this design challenge, specifically knowledge of how the best architectural intentions can result in unanticipated (sometimes devastating) outcomes—and of the conditions that gave rise to those outcomes.13 There is a third, rich source of knowledge available to guide designers that, broadly speaking, academic researchers have yet to tap into.

It is the knowledge produced by practitioners themselves. Architects learn through experience, across multiple projects and through practice-based forms of enquiry that include desktop surveys (also referred to as precedent studies), user group consultations and gathering (often informal) postoccupancy data from their clients. Architects have already offered a range of tangible solutions to meet particular aspirations related to patient care.

There is value in examining these existing design solutions to identify those capable of providing direct benefits to patients that might justify implementation across multiple projects. In understanding how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients, all available knowledge should be valued and integrated.Methodology. Embracing ‘mode two’ researchThis research was conducted within the context of a master­-planning and feasibility study, commissioned by a state government department, to investigate various international design solutions to inform future planning around forensic mental health service provisions in Victoria, Australia.

The industry-led nature of this project demanded a less conventional and more inclusive methodological approach. Tight timeframes precluded employing research methods that required ethics approvals (interviewing patients was not possible), while the timeframe and budget precluded the research team from conducting fieldwork. The following obstacles further limited a conventional approach:Postoccupancy evaluations of forensic psychiatric hospital facilities are seldom conducted and/or not made publicly available.14Published floor plans that would enable researchers to derive an understanding of the functional layouts and corresponding habits of occupancy within these facilities are limited owing to the security needs surrounding forensic psychiatric hospital sites.Available literature relevant to the design of forensic psychiatric hospital facilities provides few direct architectural recommendations to offer tactics for how the built environment might support the delivery of treatment.The team had to find a way to navigate these challenges in order to address the important question of how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients.‘Mode two’ is a methodological approach that draws on the strength of collaborations between academia and industry to produce ‘socially robust knowledge’ whose reliability extends ‘beyond the laboratory’ to real-world contexts.15 It shares commonalities with a phenomenological approach that attributes value to the prolonged, firsthand exposure of the researcher with the phenomenon in question.16 The inclusion of practising architects and academic researchers within the research team provided considerable expertise in the design, consultation and documentation of these facilities, alongside an understanding of the kinds of challenges that arise following the occupation of this building type.

Mode two, as a research approach, also recognises that, while architects reference evidence-based design literature, this will not replace the processes through which practitioners have traditionally assembled knowledge about particular building types, predominantly desktop surveys.A desktop survey was undertaken to understand contemporary design practice within this building type. Forty-four projects were identified as relevant for the period 2006–2022 (31 forensic and 13 non-forensic psychiatric hospitals). These included facilities from the UK, the USA, Canada, Denmark, Norway, Sweden, the United Arab Emirates and Ireland (online supplementary appendix 1).

Sufficient architectural information was not available for 13 of these projects and they were excluded from the study. For the remaining 31 facilities, 24 accommodated forensic patients and 7 did not. Non-forensic facilities were included to enable an awareness of any significant programmatic or functional differences in the design responses created for forensic versus non-forensic mental health patients.

Architectural drawings and photographs were analysed to identify general trends, alongside points of departure from common practice. Borrowing methods from architectural history, the desktop survey was supplemented by other available information, including a mix of hospital-authored guidebooks (as provided to patients and visitors), architects’ statements, newspaper articles and literature from the field of evidence-based design. Available data varied for each of the 31 hospitals.

Adopting a method from architectural theorist Thomas Markus, the materiality and placement of external and internal boundary lines were closely studied (assisted by Google Earth).17 When read in conjunction with the architectural drawings, boundary placement revealed information regarding patient access to adjacent landscape spaces.Supplemental materialA desktop survey has limitations. It cannot provide a conclusive understanding of how these spaces operate when occupied by patients and staff. While efforts were made to contact individual practices and healthcare providers to obtain missing details, such requests typically went unanswered.

This is likely owing to concerns of security, alongside the realities of commercial practice, concerns around intellectual property, and complex client and stakeholder arrangements that can act to prohibit the sharing of this information. To deepen the team’s understanding, a 2-day workshop was hosted to which two international architectural practices were invited to attend, one from the UK and one from the USA. Both practices had recently completed a significant forensic psychiatric hospital project.

While neither of these facilities had been occupied at the time of the workshops, the architects were able to share their experiences relative to the research, design, and client and patient consultation processes undertaken. The Australian architects who led the research team also brought extensive experience in acute mental healthcare settings, which assisted in data analysis.To further mitigate the limitations of the desktop survey, understandings developed by the team were used as a basis for advisory panel discussions with staff. Feedback was sought from five 60 min long, advisory panel sessions, each including four to six clinical/facilities staff (who attended voluntarily during work hours) from a forensic psychiatric hospital in Australia, where several participants recounted professional experience in both the Australian and British contexts.

Each advisory panel session was themed relative to various aspects of contemporary design. (1) site/hospital layout, (2) inpatient accommodation, (3) landscape design and access, (4) staff amenities, and (5) treatment hubs (referred to as ‘treatment malls’ in the American context). These sessions enabled the research team to double-check our analysis of the plans and photographs, particularly our assumptions regarding the likely use, practicality and therapeutic value of particular spaces.Model for analysisWithin general hospital design, a range of indicators are used to measure the contribution of architecture to healing, such as the optimisation of lighting to support sleep, the minimisation of patient falls, or whether the use of single patient rooms assists with control.18 In mental health, however, where the therapeutic journey is based more on psychology than physiology, what metrics should be employed to evaluate the success of one design response over another in supporting patient care?.

We suggest the first step is to acknowledge the values that underpin contemporary approaches to mental healthcare. The second step is to translate those treatment values into corresponding spatial values using a value-led spatial framework.19 This provides a checklist for relating particular spatial conditions to specific values around patient care. For example, if the design intent is to optimise privacy and dignity for patients, then the design of bathrooms, relaxation and de-esculation spaces are all important spaces in respect of that therapeutic value.

Highlighting this relationship can assist decision makers to more closely interrogate areas that matter most relative to achieving these values. To put this in context, optimising a bathroom design to prioritise a direct line of sight for staff might improve safety but also obstruct privacy and dignity for patients. While such decisions will always need to be carefully balanced, a value-led spatial framework can provide a touchstone for designers and stakeholders to revisit throughout the design process.To analyse the 31 projects examined within this project, we developed a framework (Table 1).

It recognises that a common approach to patient care can be identified across contemporary Australian, British and Canadian models:View this table:Table 1 Value-led spatial framework. Correlating treatment values with corresponding spaces within the hospital’s physical environmentThat patients be extended privacy and dignity to the broadest degree possible without impacting their personal safety or that of other patients or staff.That patients be treated within the least restrictive environment possible relative to the severity of their illness and the legal (or security) requirements attached to their care.That patients be afforded choice and independence relative to freedom of movement within the hospital campus (as appropriate to the individual), extending to a choice of social, recreational and treatment spaces.That patients’ progression through their treatment journey is reflected in the way the architecture communicates to hospital users.That opportunities for peer-led therapeutic processes and involvement of family and community-based care providers be optimised within a hospital campus. 20Table 1 assigns a range of architectural spaces and features that are relevant to each of the five treatment values listed.

Architectural decisions related to these values operate across three scales. Context, hospital and individual. Context decisions are those made in respect of a hospital’s location, including proximity to allied services, connections to public transport and distances to major metropolitan hubs.

Decisions of this type are important relative to staffing recruitment and retention, and opportunities for research relative to the psychiatric hospital’s proximity to general (teaching) hospitals or university precincts. Architectural decisions operating at the hospital scale include considerations of how secure site boundaries are provided. How buildings are laid out on a site.

And how spatial and functional links are set up between those buildings. This is important relative to the movement of patients and staff across a site, including the location and functionality of therapeutic hubs. But it can also impact patient and community psychology.

The design of external fences, in particular, can compound feelings of confinement for patients. Focus community attention on the custodial role of a facility over and above its therapeutic function. And influence perceptions of safety and security for the community immediately surrounding the hospital.

Architectural decisions operating at the ‘individual’ scale are those that more closely impact the daily experience of a hospital for patients and staff. These include the various arrangements for inpatient accommodation. Tactics for providing patients with landscape access and views.

And the question of staff spaces relative to safety, ease of communication and collaboration. Approaches to landscape, inpatient accommodation and concerns of staff supervision are closely intertwined.Findings. What we learnt from 31 contemporary psychiatric hospital projectsForensic psychiatric hospitals treat patients who require mental health treatment in addition to a history of criminal offending or who are at risk of committing a criminal offence.

Primarily, these include patients who are unfit to stand trial and those found not guilty on account of their illness.21 Accommodation is typically arranged according to low, medium or high security needs, alongside clinical need, and whether an acute, subacute, extended or translational rehabilitation setting is required. Security needs are determined based on the risk a patient presents to themselves and/or others, alongside their risk of absconding from the facility. The challenge that has proven intractable for centuries is how can architects balance privacy and dignity for patients, while maintaining supervision for their own safety, alongside that of their fellow patients, the staff providing care and, in some cases, the community beyond.22 In this section we present overall trends regarding the layout of buildings within hospital sites, including the placement of treatment hubs and the design of inpatient wards.

Access to landscape is not explicitly addressed in this section but is implicit in decisions around site layout and inpatient accommodation.Design approaches to site layoutWe identified two approaches to site layout—the ‘village’ (4 from 31 hospitals) and the ‘campus’ (27 from 31 hospitals) (figure 1). Similar in their functional arrangement, these are differentiated according to the degree of exterior circulation required to move between patient-occupied spaces. Village hospitals comprise a number of buildings sitting within the landscape, while campus hospitals have interconnected buildings with access provided by internal corridors that prevent the need to go outside.

Neither approach is new. Both follow the models first used within the 19th century. The village hospital follows the model designed by Dr Albrecht Paetz in 1878 (Alt Scherbitz, Germany), which included detached cottages accommodating patients in groups of between 24 and 100, set within gardens.23 Paetz created this design in response to his belief that upwards of 1000 patients should not be accommodated in a single building, with security measures determined in relation to those patients whose behaviour was the least predictable.24 The resulting monotony of the daily routine and restrictions on patient movement were believed to ‘cripple the intelligence and depress the spirit’.25 Paetz’s model allowed doctors to classify patients into smaller groups and unlock doors to allow patients with predictable behaviour to wander freely within the secure outer boundaries of the hospital.26 This remained the preferred approach to patient accommodation for over a century, as endorsed by the WHO in their report of 1953.27 Broadmoor Hospital (UK, 2019) provides an example of the village model.The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub.

The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub." data-icon-position data-hide-link-title="0">Figure 1 The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub. The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub.The campus model is not dissimilar to the approach propagated by Dr Henry Thomas Kirkbride, a 19th-century psychiatrist who was active in the design of asylums and whose influence saw this planning arrangement dominate asylum constructions in the USA for many decades.28 Asylums of the ‘Kirkbride plan’ arranged patient accommodation in a series of pavilions linked by corridors. While corridors can be heavily glazed, where this action is not taken, the campus approach can compromise patient and staff connections to landscape views.

Examples of campus hospitals include the Worcester Recovery Center and Hospital (USA, 2012) and the Nixon Forensic Center (USA, under construction).Treatment hubs are a contemporary addition to forensic psychiatric hospitals. These cluster a range of shared patient spaces, including recreational, treatment and vocational training facilities, and thus drive patient movement around or through a hospital site. Two different treatment hub arrangements are in use.

€˜internal’ and ‘on-edge’. Those arranged internally typically place these functions at the heart of the campus and at a significant distance from the secure boundary line. Those arranged on-edge are placed at the far end of campus-model hospitals and, in the most extreme cases, occur adjacent to one of the site’s external boundaries (refer to Figure 1).

Both arrangements aspire to make life within the hospital resemble life beyond the hospital as closely as possible, as the daily practice of walking from an accommodation area to a treatment hub mimics the practice of travelling from home to a place of work or study.With evidence mounting regarding the psychological benefits to patients of landscape access, it should not be assumed that the current preference for campus hospitals over the village model indicates ‘best practice’. A campus arrangement offers security benefits for the movement of patients across a hospital site, while avoiding the associated risks of contraband concealed within landscaped spaces. However, the existence of village hospitals for forensic cohorts suggests it is possible to successfully manage these challenges.

Why then do we see such a strong persistence of the campus hospital?. This preference may be driven by cultural expectations. From 24 forensic psychiatric hospitals surveyed, 10 were located within the USA and all employed the campus model.

Yet nine of those hospitals occupied rural sites where the village model could have been used, suggesting the influence of the Kirkbride plan prevails. The four village hospitals within the broader sample of 31, spanning forensic and non-forensic settings, all occurred within the UK3 and Ireland1. Paetz’s villa model had been the preferred approach to new constructions in these countries since its introduction at close of the 19th century.29 However, a look at UK hospitals in isolation revealed a more even spread of village and campus arrangements, with two of the four UK-based campus hospitals occupying constrained urban sites that required multi-story solutions.

The village model would be inappropriate for achieving this as it does not lend well to urban locations where land availability is scarce.Design approaches to inpatient accommodationThree approaches to inpatient accommodation were identified. €˜peninsula’, ‘race-track’ and ‘courtyard’ (Figure 2). The peninsula model is characterised by rows of inpatient wings, along a single-loaded or double-loaded corridor that stretches into the surrounding landscape.

This typically enables an exterior view from all patient bedrooms and is not dissimilar to the traditional ‘pavilion’ model that emerged within 19th-century hospital design.30 In the racetrack model bedrooms are arranged around a cluster of staff-only (or service) spaces, still enabling exterior views from all patient bedrooms. The courtyard model is similar to the racetrack but includes a central landscape space. Information on the design of inpatient room layouts was available for 24 of the 31 projects analysed (15 of these 24 were forensic).Common inpatient accommodation configurations.

(1) Peninsula. Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor).

(2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey." data-icon-position data-hide-link-title="0">Figure 2 Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped).

Staff-occupied spaces and support spaces (social space and so on) shown in grey.Ten forensic hospitals employed a peninsula plan and five employed a courtyard plan. Of the non-forensic psychiatric hospitals five employed the courtyard, three the racetrack and only one the peninsula plan. While the sample size is too small to generalise, the peninsula plan appears to be favoured for a forensic cohort.

However, cultural trends again emerge. Of the 10 peninsula plan hospitals, 6 were located within the USA, and among the broader sample of 24 (including the non-forensic facilities) none of the courtyard hospitals were located there. Courtyard layouts for forensic patients occurred within the UK, Ireland, Denmark and Sweden.

However, within these countries, a mix of courtyard and peninsula plans were used, suggesting no clear preference for one plan over the other.Each plan type has advantages and disadvantages (Table 2). Courtyard accommodation provides the following benefits. Greater opportunity for patient access to landscape since these are easier for staff to maintain surveillance over.

Additional safety for staff owing to continuous circulation (staff cannot get caught in ‘dead-ends’. However, the presence of corners which are difficult to see around is a drawback). Natural light is more easily available.

And ‘swing bedrooms’ can be supported (this is the ability to reconfigure the number of observable bedrooms on a nursing ward by opening and closing doors at different points within a corridor). However, courtyard accommodation requires a larger site area so is better suited to rural locations than urban and is not well suited to multi-story facilities. Peninsula accommodation enables geographical separation, giving medical teams greater opportunity to manage which patients are housed together (‘cohorting’).

Blind corners can be avoided to assist safety and surveillance. Travel distances can be minimised. Finally, the absence of continuous circulation provides greater flexibility for creating social spaces for patients with graduated degrees of (semi-)privacy.View this table:Table 2 Advantages and disadvantages of peninsula versus courtyard accommodationAnother important consideration related to inpatient accommodation is ward size.

The number of bedrooms clustered together, alongside the amount of dedicated living space associated with these bedrooms. Ward size can influence patient agitation and aggression, alongside ease of supervision, staff anxiety and safety.31 The most common ward sizes were 24 or 32 beds, further subdivided into subclusters of 8 beds. Typically, each ward was provided with one large living space that all 24 or 32 patients used together.

More advanced approaches gave patients a choice of living spaces. For example, at Coalinga Hospital, patients could occupy a small living space available to only 8 patients, or a larger space that all 24 patients had access to. We describe this approach as more advanced since both 19th-century understandings alongside recent research by Ulrich et al confirm that social density (the number of persons per room) is ‘the most consistently important variable for predicting crowding stress and aggressive behaviour’.32 Only six hospitals had plans detailed enough to calculate the square-metre provision of living space per patient, and this varied between 5 and 8 square metres.Limitations of the desktop surveyData from a desktop survey are insufficient to obtain a comprehensive understanding of how design contributes to patient experience.

To overcome this limitation, the following sections combine knowledge about how people use space from environmental psychology, knowledge about the design and consultation processes that guide the construction of these facilities, and understandings from architectural history. History suggests that seemingly small changes to typical design practice can effect significant change in the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. This integrated approach is used to identify three forensic psychiatric hospitals that challenge accepted design practice to varying degrees and, in doing so, have the potential to act as change-agents in the delivery of forensic mental healthcare.

But first it is important to understand the context in which architectural innovation is able, or unable, to emerge relative to forensic mental healthcare.Accepting the challenge. Using history to help us see beyond the roadblocks to innovationArchitects tasked with designing forensic mental health facilities respond to what is called a ‘functional brief’. This documents the specific performance requirements of the hospital in question.

Much consultation goes into formulating and refining a functional brief through the initial and developed design stages. Consultation is typically undertaken with a variety of different user groups, and in a sequential fashion that includes a greater cross-section of users as the design progresses, including patients, families, and clinical and security staff. Despite the focus on patient experience within contemporary models of care, functional briefs tend to prioritise safety and security, making them the basis on which most major architectural decisions are made.33 In large part this is simply the reality of accommodating a patient cohort who pose a risk of harm towards themselves and/or others.

A comment from Tom Brooks-Pilling, a member of the design team for the Nixon Forensic Center (Fulton, Missouri), provides insight into this approach and the concerns that drive it. He explained that borrowing a ‘spoked wheel’ arrangement from prison design eliminated blind spots and hiding places to enable a centrally located staff member to:see everything that’s going on in that unit…[they are] basically watching the other staff’s back [sic] to make sure that they can focus on treatment and not worry about who might be sneaking up on them or what activities might be going on behind their backs.34Advisory panel feedback confirmed that when the architectural design of a facility heightens staff anxiety this has direct ramifications for the therapeutic process. For example, in spaces where staff could become isolated from one another, and where clear lines of sight were obstructed, such as ill-designed elevators or stairwells, this can lead to movement being reduced across the patient cohort to avoid putting staff in those spaces where they feel unsafe.The architects consulted during the course of this research, including those who were part of the research team, articulated how the necessary prioritisation of safety, in turn, leads to compromises in the attainment of an ideal environment to support treatment.

In the various forensic and acute psychiatric hospital projects they had been involved with, all observed a sincere commitment on the part of those engaged in project briefing to upholding ideals around privacy, dignity, autonomy and freedom of movement for patients. They reported, however, that the commitment to these ideals was increasingly obstructed as the design process progressed by the more pressing concerns of safety. Examples of the kinds of architectural implications of this prioritisation are things like spatially separated nursing stations (enclosed, often fully glazed), when a desire for less-hierarchical interactions between patients and staff had been expressed at the beginning of the briefing process.

Or the substitution of harder-wearing materials, with a more ‘institutional’ feel when a ‘home-like’ atmosphere had been prioritised initially. There is nothing surprising or unusual about this process since design is, by its nature, a process of seeking improvements on accepted practice while systematically checking the suitability of proposed solutions against a set of performance requirements. In the context of forensic psychiatric hospitals, safety is the performance requirement that most often frustrates the implementation of innovative design.

Thus, amid the complexities of design and procurement relative to forensic psychiatric hospitals, innovation, however humble, and particularly where it can be seen to contribute positively to the patient experience, is worth a closer look.In the historical development of the psychiatric hospital as a building type, two significant departures from accepted design practice facilitated positive change in the treatment of mental illness. The first was Paetz’s development of the village hospital which sought to replace high fences, locked doors and barred windows with ‘humane but stringent supervision’.35 While this planning approach may not have significantly altered models of care, it was regarded as ‘an essential, vital development’, providing architectural support to the prevailing approach to treatment of the time—that of moral treatment—which aimed to extend kindness and respect to patients, in an environment that was as unrestrictive as possible. The York Retreat is worthy of acknowledgement here as a leading proponent of moral treatment whose influence shifted approaches to asylum design, from focusing on the provision of safe custody to supporting the restoration of sanity.

Architecturally, however, the differences in the York Retreat’s approach were mainly focused on interior details that encouraged patients to maintain civil habits. Dining rooms had white tablecloths and flower vases adorned mantelpieces, door locks were custom-made to close quietly, and window bars fashioned to look like domestic window frames.36 The York Retreat was originally a small institution, in line with Samuel Tuke’s preference for a maximum asylum size of 30 patients. History confirms the extent to which this approach was not scalable and thus unable to be replicated widely for asylum construction.

For these reasons, it has not been considered here as a significant departure from accepted design practice.The second significant departure from accepted design practice was the development of acute treatment hospitals, located within cities, adjacent to general hospitals and medical research facilities. The first hospital of this type was the Maudsley Hospital, led by doctors Henry Maudsley and Frederick Mott, in London. The design intent for this hospital was announced in 1908 but it was not opened until 1923.37 In proposing this hospital, Maudsley and Mott were motivated to bring psychiatry ‘into line with the other branches of medical science’.38 This 100-bed facility, located directly across the road from the King’s College (Teaching) Hospital, emulated the general hospital typology in offering both outpatient and short-duration inpatient care, specifically targeted at patients with recent-onset illnesses.

The aspirations were threefold. To avoid the stigma associated with large public asylums. To advance the medical understanding of mental illness through research collaborations with general hospitals and medical schools and via improved teaching programmes.

And to both enable and encourage patients to access early, voluntary treatment on an outpatient basis.38 Today the Maudsley appears unremarkable, an unassuming three-storied building on a busy London street. But the significance of what this building communicated at the time it was constructed, and the extent to which it challenged accepted practice, should not be underestimated. The Maudsley sent a clear message to the public that mental illness was no longer to be regarded as different from any other illness treated within a general hospital setting.

That it was no longer okay to isolate those suffering from mental illness from their families or the neighbourhoods in which they lived.39 Following the announcement of the Maudsley, the ‘psychopathic hospital’ rose to prominence within the USA with Johns Hopkins University Hospital opening the Phipps Psychiatric Clinic, in Baltimore, in 1913. The psychopathic hospital similarly promoted urban locations and closer connections to teaching and research. The Maudsley can be seen to have played a significant role in the shift to treating acute mental illness within general hospital settings.In any discussion of the history of institutional care, there is a responsibility to acknowledge that the aspiration to provide buildings that support care and recovery have not always manifested in ways that improved daily life for patients.

The five treatment values that underpinned the analysis framework for this project are not new values. The extension of privacy and dignity to patients and the delivery of care within the least restrictive environment possible were both firmly embedded in the 19th-century approach of moral treatment. Yet the rapid growth of asylum care frustrated the delivery of those values to patients.40 Choice and independence for patients, the desire for a patient’s recovery progress to be reflected in their environment, and opportunities for peer support and family involvement have been present in approaches to mental health treatment since the formal endorsement of the ‘therapeutic community’ approach to hospital construction and administration in the WHO’s report of 1953.41 History reminds us, therefore, that differences can arise between the stated values on which an institution is designed and those which it is constructed and operated.

The three hospitals discussed in the following section include innovative solutions that hold the promise of positive benefits for patients. Yet we acknowledge this a theoretical analysis. For concrete evidence of a positive relationship between these design outcomes and patient well-being, postoccupancy evaluations are required.Three hospitals contributing to positive change in forensic mental healthcareBroadmoor Hospital.

Optimising the value of the village model for patientsNineteenth-century beliefs and contemporary research are in accord regarding the importance of greenspace in reducing agitation within forensic psychiatric hospital environments and in promoting positive patterns of socialisation.42 It is surprising, therefore, that enshrining daily landscape access for patients is not widespread within current design practice. The Irish National Forensic Mental Hospital and the State Hospital at Carstairs (Scotland) both follow the model of the village hospital, but only in that they comprise a number of accommodation buildings set within the landscape, enclosed by an external boundary fence. At the Irish National Forensic Mental Hospital, the scale of the landscape—the distance between buildings and the lack of intermediate boundaries within the landscape—suggests it is highly unlikely that patients are allowed to navigate this landscape on a regular basis.

By comparison, the architectural response developed for Broadmoor Hospital (2019) shows an exemplary commitment to patient views and access to landscape (Figure 3).Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK)." data-icon-position data-hide-link-title="0">Figure 3 Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK).Five contemporary hospitals follow the logic of a traditional villa hospital, yet Broadmoor is the only one that optimises the benefits offered by this spatial configuration.

Comprising a gateway building and a central treatment hub, with a series of patient accommodation buildings positioned around it, the landscape becomes the only available circulation route for patients travelling off-ward to the shared therapy, recreation and vocational training spaces. Most patients will thus engage with the outdoors at least twice daily on their way to and return from these shared spaces. But in addition to accessing this central landscape, landscape views from patient rooms have been prioritised, and each ward is allocated its own large greenspace.

Multiple, internal boundary fences enable patient access to the adjacent landscape to the greatest possible degree (refer to Figure 3). This approach provides patients with a diversity of landscape experiences. This is important given the patterns of landscape use between forensic and non-forensic hospitals.

In non-forensic facilities, patients are likely to have the choice of accessing multiple landscape spaces, whereas in forensic facilities access to a particular space is often restricted to one cohort, for example, a single ward group. This highlights a limitation of the courtyard model for forensic patients. Roseberry Park Hospital (2012) provides an example of how a high degree of landscape access can be similarly achieved for patients on constrained urban site, using a courtyard layout (refer to Figure 3).Providing patients with daily landscape access provides challenges to maintaining safety and security.

Trees with low branches can be used as weapons, while tall branches can be used for self-harm, and ground cover landscaping increases opportunities to conceal contraband. At the Australian hospital where advisory panel sessions were conducted (constructed in 2000), the landscape is occupied in a similar way and staff conveyed the constant effort required to ensure safe patient access to this greenspace. Significant costs are incurred annually by facilities staff in keeping the greenspace free from contraband and from several varieties of wild mushroom that grow seasonally on the site.

Despite this cost, staff reported that both they and the patients value the opportunity to circulate through the landscaped grounds (even in inclement weather). Hence, the benefits to well-being are perceived as significant enough to justify this cost. These examples make evident that placing a hospital within a landscape is not enough to ensure patients are extended the well-being benefits of ongoing access.

Instead this requires that hospitals factor in the additional supervisory and maintenance requirements to maintain landscape access for patients.Worcester Recovery Center and Hospital. Spaces to support choice and a sense of controlResearch in environmental psychology, conducted within residential and hospital settings, confirms that the ability to regulate social contact can have a dramatic impact on well-being. The physical layout of spaces has been linked to both the likelihood of developing socially supportive relationships and impeding this development, with direct implications for communication, concentration, aggression and a person’s resilience to irritation.43 These problems can be more pronounced in a forensic psychiatric hospital as there is an over-representation of patients who have suffered trauma.

Architects working in forensic psychiatric hospital design acknowledge that patients need space to withdraw from the busy hospital environment, spaces where they can ‘observe everything that is going on around them until they feel ready to join in’.44 It is surprising, therefore, that many contemporary forensic psychiatric hospitals still continue to provide a single social space for all 24 or 32 patients occupying a ward. The Worcester Recovery Center, by comparison, provides patients with a choice of social spaces that are designed to enable graduated degrees of social engagement. This can support a sense of control to limit socially induced stress.Worcester is conceptualised as three distinct zones designed to resemble life beyond the hospital.

The ‘house’, ‘neighbourhood’ and ‘downtown’ (Figure 4). The house zones include patient accommodation, employing a peninsula model. Each comprises 26 patient rooms, clustered into groups of 6 or 10 single bedrooms that face a collection of shared spaces dedicated to that cluster, including sitting areas, lounges and therapeutic spaces.

A shared kitchen and dining room is provided for each house. Three houses feed into a neighbourhood zone that includes shared spaces for therapy and vocational training, while the downtown zone serves a total of 14 houses. The downtown zone can be accessed by patients based on a merit system and includes a café, bank and retail spaces, music room, health club, chapel, green house, library and art rooms, alongside large interior public spaces.

This array of amenities does not seem distinctly different from other contemporary facilities, where therapy and vocational training happen in a mix of on-ward and off-ward (often within a central treatment hub). The difference lies in the sensitivity of how these spaces are articulated.Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’." data-icon-position data-hide-link-title="0">Figure 4 Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’.The generosity of providing separate living spaces for every 6–10 patients and locating these directly across the corridor from the patient rooms supports a sense of control and choice for patients. Frank Pitts, an architect who worked on the Worcester project, has written that this was done to enable patients to ‘decide whether they are ready to step out and socialise or return to the privacy of their room’.45 This approach filters throughout the facility, providing a slow graduation of social engagement opportunities for patients, from opportunities to socialise with their cluster of 6–10 individuals, to their house of 26, to their neighbourhood of 78 people, to the full downtown experience.

According to the architects, the neighbourhood thus provides an intermediary zone between the quiet house and the active downtown, which can be overwhelming for some patients.46 Importantly the scale of the architecture responds to this transition from personal to public space, providing visual indicators to reflect patients’ movement through their treatment journey. Spaces become larger as they move further from the ward. This occurs because instead of providing a single, large shared living space, patients are provided a choice of smaller spaces to occupy—these are not much bigger than a patient bedroom.

Dining spaces are slightly larger, while downtown spaces have a civic quality. These are double-height, providing a greater sense of light and airiness. These are arranged in a semicircle, opening onto a large veranda and greenspace.

The sensitive articulation of these spaces, with regard to both their graduated physical scale and the proximity of the social spaces to the patient bedrooms, provides spatial support to these social transitions while empowering patients to control their own level of social interaction.Margaret and Charles Juravinski Centre for Integrated Healthcare. Creating opportunities for greater public engagement and supporting readjustment to the world beyond the hospitalOne of the most significant barriers to mental health treatment is the stigma associated with admission to a psychiatric hospital. We know that discrimination poses an obstacle to recovery and that the media fuels public fears related to forensic mental health patients.47 Two further challenges to mental health delivery include the disconnection patients can experience from the community, including from family and educational opportunities, and the risk of readmission in the period immediately following discharge.48 If architecture is capable of acting as a change-agent in the delivery of mental healthcare, then it needs to show leadership, not only in the provision of a better experience for patients but more broadly in taking steps to help shift public perceptions around mental illness.

The Margaret and Charles Juravinski Centre for Integrated Healthcare (MCJC) (Canada) displays several similarities with the approach taken to the Maudsley Hospital. Its appearance communicates a modern, cutting-edge healthcare facility. It does not hide on a rural site or behind walls.

At five stories, and extensively glazed, MCJC communicates a strong civic presence. Its proximity to McMaster University (6 km) and to neighbouring general hospitals, including Juravinski Hospital (4 km) and Hamilton General Hospital (4 km), positions it well for research collaborations to occur, while its proximity to the Mohawk Community College, across the road, can enable patients with leave privileges to access vocational training. More importantly, it employs three innovative design tactics to target the challenges of contemporary forensic mental healthcare, providing an example for how architecture might broker positive change.The first innovative design strategy is the co-location of support services for outpatient mental healthcare.

The risk of readmission is highest immediately following discharge. A lack of collaboration between outpatient support services can result in fragmented care when patients are most vulnerable to the stresses associated with readjustment to the world beyond.49 MCJC includes outpatient facilities allowing patients to use the hospital as a stable base, or touchstone, in adjusting to life after discharge. Bringing these services onto the same physical site can also improve opportunities for coordination between inpatient and outpatient support services which can support continuity of care.

The second design strategy is the co-location of a medical ambulatory care centre which includes diagnostic imaging, educational and research facilities. This creates reasons for the general public to visit this facility, setting up the opportunity for greater public interaction. This could potentially advance understandings of the role of this facility and the patients it treats.The third innovative design strategy was to optimise the on-edge treatment hub for public engagement.

While adopted across a number of hospitals, including Hawaii State Hospital, Helix Forensic Psychiatry Clinic (Sweden) and the Worcester Recovery Center, the on-edge treatment hubs at these hospitals are buried deep inside the secure outer boundary. At MCJC, the treatment hub is placed adjacent to the public zones of the hospital—although on the second floor—and this can be viewed as extension of the public realm and enables the potential for the public to be brought right up to the secure boundary line (which occurs within the building). MCJC is divided into four zones.

The public zone, the galleria (the name given to the treatment hub), the clinical corridor and inpatient accommodation (Figure 5). The galleria functions similarly to the downtown at the Worcester Recovery Center. Patients are given graduated access to a series of spaces that support their recovery journey.

These include a gym, wellness centre, spiritual centre, library, café, beauty salon, and retail and financial services, alongside patient and family support services. While the galleria was initially intended to be accessible by the general public, this was not immediately implemented on the facilities’ opening and it is unclear whether this has now occurred.50 Nonetheless, the potential for movement of patients outwards, and families inwards, has been built into the physical fabric of this building, meaning opportunities for social interaction and fostering greater public understanding are possible. If understanding is the antidote to discrimination, then exposing the public to the role of this facility and the patients it treats is an important step in the right direction.Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare.

The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated." data-icon-position data-hide-link-title="0">Figure 5 Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare.

The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated.ConclusionThe question of how architecture can support the therapeutic journey of forensic mental health patients is a critical one.

Yet the availability of evidence-based design literature to guide designers cannot keep pace with growing global demand for new forensic psychiatric hospital facilities, while limitations remain relative to the breadth and usability of this research. A narrow view of what constitutes credible evidence can overlook the value of knowledge embedded in architectural practice, alongside that held by architectural historians and lessons from environmental psychology. In respect of such a pressing and important problem, there is a responsibility to integrate knowledge from across these disciplines.

Accepting the limitations of a theoretical analysis and of the desktop survey method, we also argue for its value. Architects learn through experience, across multiple projects. This gives weight to the value of examining existing, contemporary design solutions to identify architectural innovations capable of providing benefits to patients and thus perhaps worthy of implementation across multiple projects.

History gives us reason to believe that small changes to typical design practice can improve the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. Architecture has the capacity to contribute to positive change.Here, we have provided a nuanced way for architects and decision makers to think about the relationship between architectural space and treatment values. An institution’s model of care and the therapeutic values that underpin that model of care should be placed at the centre of architectural decision making.

A survey of contemporary architectural solutions confirms that, generally speaking, innovation is lacking in this field. There will always be real obstacles to innovation, and the argument presented here does not suggest it is necessarily practical to prioritise therapeutic values at the cost of patient, staff and community safety. Instead, it challenges architects and decision makers to properly interrogate any architectural decision that compromises an initial commitment to supporting a patient’s treatment journey—to be more idealistic in the pursuit of positive change.Tangible examples exist of architectural innovations capable of positively improving patient experience by supporting key values that underpin contemporary treatment approaches.

The Broadmoor Hospital optimises the value of the village model for patients, prioritising patient needs for frequent landscape engagement to support their therapeutic journey. The Worcester Recovery Center provides a generous choice and graduation of social spaces to support the social reintegration of patients at their own pace. MCJC co-located facilities to support a patient’s readjustment to daily life postdischarge, while creating opportunities for public engagement that has the potential to foster greater public understanding of the role of these institutions and the patients they treat.

In identifying these three innovative design approaches, we provide architects with tangible design tactics, while encouraging researchers to look more closely at these examples with targeted, postoccupancy studies. These projects provide hope that with a shared vision and commitment, innovation is possible in forensic psychiatric hospital design, with tangible benefits for patients.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary information. The primary method undertaken for this research relied on data publicly available on the internet.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsThe opportunity to conduct this project arose out of a multidisciplinary master-planning and feasibility study, commissioned by the Victorian Health and Human Services Building Authority, to investigate various international solutions to inform future planning and design around forensic mental health service provision.

The following people contributed their time and expertise in shaping the research process that enabled this article. Neel Charitra, Stefano Scalzo, Les Potter, Margaret Grigg, Lousie Bawden, Matthew Balaam, Martin Gilbert, John MacAllister, Crystal James, Jo Ryan, Julie Anderson, Jo Wasley, Sophie Patitsas, Meagan Thompson, Judith Hemsworth, James Watson, Viviana Lazzarini, Krysti Henderson, Nadia Jaworski, Jack Kerlin and Jan Merchant.Notes1. Jamie O'Donahoo and Janette Graetz Simmonds (2016), “Forensic Patients and Forensic Mental Health in Victoria.

Legal Context, Clinical Pathways, and Practice Challenges,” Australian Social Work 69, no. 2. 169–80.2.

The challenge of which terminology to select when writing about psychiatric hospital design remains difficult relative to the stigmas that surround this field. The term ‘patient’ has been used throughout, instead of ‘consumer’, as this article spans both historical and contemporary developments. In the context of this timespan, consumer is a relatively recent term, introduced around 1985.3.

B Edginton (1994), “The Well-Ordered Body. The Quest for Sanity through Nineteenth-Century Asylum Architecture,” Canadian Bulletin of Medical History 11, no. 2.

375–86. Clare Hickman (2009), “Cheerful Prospects and Tranquil Restoration. The Visual Experience of Landscape as Part of the Therapeutic Regime of the British Asylum, 1800-60,” History of Psychiatry 20, no.

4 Pt 4. 425–41. Rebecca McLaughlan, 2012), “Post-Rationalisation and Misunderstanding.

Mental Hospital Architecture in the New Zealand Media,” Fabrications 22, no. 2. 232–56.4.

Roger S Ulrich et al. (2008), “A Review of the Research Literature on Evidence-Based Healthcare Design,” HERD 1, no. 3.

61–125. Jill Maben et al. (2015), “Evaluating a Major Innovation in Hospital Design.

Workforce Implications and Impact on Patient and Staff Experiences of All Single Room Hospital Accommodation,” Health Services and Delivery Research 3. 1–304. Penny Curtis and Andy Northcott (2017), “The Impact of Single and Shared Rooms on Family-Centred Care in Children’s Hospitals,” Journal of Clinical Nursing 26, no.

Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” Journal of Environmental Psychology 57. 53–66.6.

Graham A Tyson, Gordon Lambert, and Lyn Beattie (2002), “The Impact of Ward Design on the Behaviour, Occupational Satisfaction and Well-Being of Psychiatric Nurses,” International Journal of Mental Health Nursing 11, no. 2. 94–102.7.

For further examples of this see Jon E. Eggert et al. (2014), “Person-Environment Interaction in a New Secure Forensic State Psychiatric Hospital,” Behavioral Sciences &.

C.C. Whitehead et al. (1984), “Objective and Subjective Evaluation of Psychiatric Ward Redesign,” The American Journal of Psychiatry 141, no.

(2011), “Client-Centered Design of Residential Addiction and Mental Health Care Facilities. Staff Perceptions of Their Work Environment,” Qualitative Health Research 21, no. 11.

1527–38.8. Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities.

Visions and Outcomes,” Facilities 31, no 1/2. 24–88.9. For examples see Kathleen Connellan et al.

(2013), “Stressed Spaces. Mental Health and Architecture,” HERD. Health Environments Research &.

Constantina Papoulias et al. (2014), “The Psychiatric Ward as a Therapeutic Space. Systematic Review,” British Journal of Psychiatry 205, no.

Allen and R.G. Nairn, 1997. Alan Dilani, 2000, “Psychosocially Supportive Design - Scandinavian Health Care Design,” World Hospitals and Health Services 37.

20–4. Rebecca McLaughlan (2018), “Psychosocially Supportive Design. The Case for Greater Attention to Social Space within the Pediatric Hospital," HERD 11, no.

2. 151–62.11. Rebecca McLaughlan (2017), “Learning From Evidence-Based Medicine.

Exclusions and Opportunities within Health Care Environments Research,” Design for Health 1. 210–28.12. B Edginton (1997), “Moral Architecture.

The Influence of the York Retreat on Asylum Design,” Health &. Place 3, no. 2.

91–9. Jeremy Taylor (1991), Hospital and Asylum Architecture in England 1849–1914. Building for Health Care (London.

Mansell Publishing Limited). Anne Digby (1985), Madness, Morality and Medicine. A Study of the York Retreat 1796–1914 (New York.

Cambridge University Press).13. Digby, Madness, Morality and Medicine. Erving Goffman (1961), Asylums.

Essays on the Social Situation of Mental Patients and Other Inmates (New York. Doubleday). Ivan Belknap (1956), Human Problems of a State Mental Hospital (New York.

Blakiston Division, McGraw-Hill). Andrew Scull (1979), Museums of Madness. The Social Organization of Insanity in 19th Century England (London.

Allen Lane). Leonard Smith (1999), Cure, Comfort and Safe Custody. Public Lunatic Asylums in Early Nineteenth-Century England (London.

Leicester University Press). Rebecca McLaughlan (2014), “One Dose of Architecture, Taken Daily. Building for Mental Health in New Zealand” (PhD diss., Victoria University of Wellington, New Zealand).14.

Although not fitting a strict definition of postoccupancy evaluation, the following articles were notable exceptions to this finding. Eggert et al., “Person-Environment Interaction,” 527–38. Roger S.

Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. Catherine Clark Ahern et al.

(2016), “A Recovery-Oriented Care Approach. Weighing the Pros and Cons of a Newly Built Mental Health Facility,” Journal of Psychosocial Nursing and Mental Health Services 54, no. 2.

39–48.15. M Gibbons (2000), “Mode 2 Society and the Emergence of Context-Sensitive Science,” Science and Public Policy 27. 161.16.

D Seamon, 2000, “A Way of Seeing People and Place,” in Theoretical Perspectives in Environment-Behavior Research, ed. S. Wapner, J.

Demick, T. Yamamoto and H. Minami (New York.

Plenum), 157–78.17. Thomas A Markus (1982), Order in Space and Society. Architectural Form and Its Context in the Scottish Enlightenment (Edinburgh.

Mainstream Publishing Company).18. Ulrich et al., “A Review of the Research Literature,” 61–125.19. This was first created by first author for use for historical analysis during her PhD and is applied here to a contemporary setting.

Refer to McLaughlan, “One Dose of Architecture, Taken Daily.”20. The following documents were referenced in compiling this list. Joint Commission Panel for Mental Health, NHS, UK (2013), “Guidance for Commissioners of Forensic Mental Health Services,” May, https://www.jcpmh.info/resource/guidance-for-commissioners-of-forensic-mental-health-services/.

Cannon Design (2014), “St Joseph’s Integrated Healthcare Hamilton, Margaret and Charles Juravinski Centre for Integrated Healthcare,” Healthcare Design Showcase, September. Health Nexus Group, 2017, “Forensicare Model of Care Report,” April, Australia (access provided by the Victorian Health and Human Services Building Authority). Donald Cant Watts Corke (2014), “Service Plan for Forensic Mental Health Services,” July, Australia (access provided by the Victorian Health and Human Services Building Authority).21.

Sometimes this includes patients with no history of criminal behaviour but who are unable to be treated safely in a general hospital environment.22. W.A.F Browne (1991), "What Asylums Were, Are and Ought to Be (1837),” reprinted in The Asylum as Utopia. W.A.F.

Browne and the Mid-Nineteenth Century Consolidation of Psychiatry, ed. Andrew Scull (London. Tavistock).

Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38. Eggert et al., “Person-Environment Interaction.”23.

Anon (1895), “Review. The Colonization of the Insane in Connection with the Open-Door System. Its Historical Development and the Mode in Which It Is Carried Out at Alt Scherbitz Manor.

By Dr. Albrecht Paetz, Director of the Provincial Institution for the Insane (Berlin. Springer, 1983),” The Journal of Mental Science 41.

697–703.24. Theodore Gray (1958), The Very Error of the Moon (Ilfracombe &. Devon.

Arthur H. Stockwell Ltd), 64.25. John Galt (1854), “The Farm of St.

Anne,” American Journal of Insanity II (1854). 352.26. Galt, “The Farm of St.

Anne,” 352.27. Martin James (1948), “Diagnostic Measures,” in Modern Trends in Psychological Medicine, ed. Noel Haris (London.

World Health Organization (1953), The Community Mental Hospital. Third Report of the Expert Committee on Mental Health (Geneva. WHO).28.

Carla Yanni (2007), The Architecture of Madness. Insane Asylums in the United States. Minneapolis (London.

University of Minnesota Press).29. Key British examples included the 1923 rebuild of London’s Bethlem Hospital which followed the villa model, alongside Shenley Park Mental Hospital (Middlesex County) and Barrow Mental Hospital (Somerset), both constructed in the early 1930s.30. Taylor, Hospital and Asylum Architecture in England.31.

Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. O. Jenkins, S.

Dye and C. Foy (2015) (Oliver Jenkins et al., 2015), “A Study of Agitation, Conflict and Containment in Association With Change in Ward Physical Environment,” Journal of Psychiatric Intensive Care 11, no. 01.

Mayer, and T. Martin (2004), “Environmental Contributors to Aggression in Two Forensic Psychiatric Hospitals,” International Journal of Forensic Mental Health 3 no. 1.

(1994), “Patient Overcrowding in Psychiatric Hospital Units. Effects on Seclusion and Restraint,” Administration and Policy in Mental Health 22, no. 2.

133–44. T. T Palmstierna, B Huitfeldt, and B Wistedt (1991), “The Relationship of Crowding and Aggressive Behavior on a Psychiatric Intensive Care Unit,” Psychiatric Services 42, no.

12. 1237–40.32. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 57.

Charles Mercier (1894), Lunatic Asylums. Their Organisation and Management (London. Charles Griffin and Company), 135.33.

Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38. Joel A Dvoskin et al.

(2002), “Architectural Design of a Secure Forensic State Psychiatric Hospital,” Behavioral Scients &. The Law, 20, no. 3.

Maclnnes (1999), “The Relationship between Building Design and Escapes from Secure Units,” Journal of the Royal Society for the Promotion of Health 119, no. 3. 170–4.

Jon E. Eggert et al. (2014), “Person-Environment Interaction,” 527–38.34.

Tom Brooks-Pilling cited in Mike Lear (2015), “Designer. New Fulton State Hospital Will Be Better, Safer,” Missourinet, January 5, https://www.missourinet.com/2015/01/05/designer-new-fulton-state-hospital-will-be-better-safer/35. Leslie Topp (2007), “The Modern Mental Hospital in Late Nineteenth-Century Germany and Austria.

Psychiatric Space and Images of Freedom and Control,” in Madness, Architecture and the Built Environment. Psychiatric Spaces in Historical Context, ed. Leslie Topp, James Moran and Jonathan Andrews (London and New York.

Routledge), 244.36. McLaughlan, “One Dose of Architecture, Taken Daily,” 35. Digby, Madness, Morality and Medicine.37.

Anon (1908), “Proposed New Hospital for Mental Diseases,” The Lancet 171, no. 4410. 728–9.38.

Anon, “Proposed New Hospital for Mental Diseases.”39. McLaughlan, “One Dose of Architecture, Taken Daily.”40. Samuel Tuke (1964), “Description of the Retreat (1813),” reprinted in Description of the Retreat With an Introduction by Richard Hunter and Ida Macalpine (London.

Dawsons of Paul Mall). Scull, Museums of Madness. Digby, Madness, Morality and Medicine.

Smith, Cure, Comfort and Safe Custody.41. World Health Organization (1953), The Community Mental Hospital. Also refer to T.F Main (1946), “The Hospital as a Therapeutic Institution”, Bulletin of the Menninger Clinic 10, no.

3. 66–71. David Clark (1965), “The Therapeutic Community Concept, Practice and Future,” The Journal of Mental Science 111.

947–54.42. Jolanda Maas et al. (2009), “Social Contacts as a Possible Mechanism behind the Relation between Green Space and Health,” Health &.

Gayle Souter-Brown (2015), Landscape and Urban Design for Health and Well-Being. Using Healing, Sensory and Therapeutic Gardens (Oxon &. New York.

Routledge). Ulrich et al., “A Review of the Research Literature,” 61–125.43. Leon Festinger et al.

(1950), Social Pressures in Informal Groups. A Study of Human Factors in Housing, vol. 11 (New York.

Harper Bros). David Halpern (1995), Mental Health and the Built Environment. More than Bricks and Mortar?.

Baum and G.E. Davis (1980), “Reducing the Stress of High-Density Living. An Architectural Intervention,” Journal of Personality and Social Psychology 38, no.

Altman and M.M. Chemers (1984), Culture and Environment (Monterey, CA. Brooks &.

Cole Publishing). Gary W Evans (2003), “The Built Environment and Mental Health,” Journal of Urban Health. Bulletin of the New York Academy of Medicine 80 no.

4. 536–55. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66.44.

Stence Guldager cited in Troldtekt, “Innovative Architecture is Good for Mental Health,” https://www.troldtekt.com/News/Themes/Healing_architecture/Innovative_architecture_is_good_for_mental_health (accessed June 30, 2019). Clare Hickman and “Cheerful Prospects (2009).45. Frank Pitts cited in Patricia Wen (2012), “For Mentally Ill, A Design Departure,” B News, August 16, https://www.boston.com/news/local-news/2012/08/16/for-mentally-ill-a-design-departure46.

Ellenzweig with Architecture Plus, “Massachusetts Department of Mental Health, Worcester Recovery Center and Hospital – Worcester, MA,” Healthcare Design (2013), July 30, https://www.healthcaredesignmagazine.com/architecture/massachusetts-department-mental-health-worcester-recovery-center-and-hospital-worcester-ma/47. Sane Australia (2003), “A Life Without Stigma,” July 25, http://apo.org.au/resource/life-without-stigma. Otto F Wahl (2012), “Stigma as a Barrier to Recovery from Mental Illness,” Trends in Cognitive Sciences 16, no.

1. 9–10. New Zealand Ministry of Health and Health Promotion Agency (2014), “Like Minds, Like Mine National Plan 2014–2019.

Programme to Increase Social Inclusion and Reduce Stigma and Discrimination for People with Experience of Mental Illness,” May 20, https://www.likeminds.org.nz/assets/National-Plans/like-minds-like-mine-national-plan-2014-2019-may14.pdf. G Moon (2000), “Risk and Protection. The Discourse of Confinement in Contemporary Mental Health Policy," Health &.

R. Allen and R.G. Nairn (1997), “Media Depictions of Mental Illness.

An Analysis of the Use of Dangerousness,” Australian &. New Zealand Journal of Psychiatry 31, no. 3.

375–81. Greg Philo et al. (1994), “The Impact of the Mass Media on Public Images of Mental Illness.

Media Content and Audience Belief,” Health Education Journal 53, no. 3. 271–81.48.

G Moon (2000), “Risk and Protection,” 239–50. T.F Main (1948), “Rehabilitation and the Individual,” in Modern Trends in Psychological Medicine, ed. Noel Haris (London.

D.A Fuller, E. Sinclair, and J. Snook (2016), “Released, Relapsed, Rehospitalized.

Length of Stay and Readmission Rates in State Hospitals. A Comparative State Survey,” 2016, https://www.treatmentadvocacycenter.org/storage/documents/released-relapsed-rehospitalized.pdf. Leila Salem et al.

(2015), “Supportive Housing and Forensic Patient Outcomes,” Law and Human Behavior 39, no. 3. 311.49.

National Institute for Health and Clinical Excellence, Manchester (2016), “Transition between Inpatient Mental Health Settings and Community or Care Home Settings. Guideline,” August, https://www.nice.org.uk/guidance/ng53/evidence/full-guideline-pdf-260695191750. Catherine Clark Ahern et al.

(2016), “A Recovery-Oriented Care Approach,” 47..

What should I tell my health care provider before I take Lasix?

They need to know if you have any of these conditions:

  • abnormal blood electrolytes
  • diarrhea or vomiting
  • gout
  • heart disease
  • kidney disease, small amounts of urine, or difficulty passing urine
  • liver disease
  • an unusual or allergic reaction to furosemide, sulfa drugs, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

Intravenous lasix

IntroductionLa Peste intravenous lasix (Camus 1947) has served as a basis for several critical works, including some in the field of medical humanities (Bozzaro 2018. Deudon 1988. Tuffuor and intravenous lasix Payne 2017).

Frequently interpreted as an allegory of Nazism (with the plague as a symbol of the German occupation of France) (Finel-Honigman 1978. Haroutunian 1964), it has also received philosophical readings beyond the sociopolitical context in which it was written (Lengers 1994). Other scholars, on the other hand, have centred their analyses on its literary aspects (Steel 2016).The hypertension medications lasix has increased general interest about historical intravenous lasix and fictional epidemics.

La Peste, as one of the most famous literary works about this topic, has been revisited by many readers during recent months, leading to an unexpected growth in sales in certain countries (Wilsher 2020. Zaretsky 2020). Apart from that, commentaries about the novel, especially among health sciences scholars, have emerged intravenous lasix with a renewed interest (Banerjee et al.

2020. Bate 2020. Vandekerckhove 2020 intravenous lasix.

Wigand, Becker, and Steger 2020). This sudden curiosity is easy to understand if we consider both La Peste’s literary value, and people’s desire to discover real or fictional situations similar to theirs. Indeed, Oran inhabitants’ experiences intravenous lasix are not quite far from our own, even if geographical, chronological and, specially, scientific factors (two different diseases occurring at two different stages in the history of medical development) prevent us from establishing too close resemblances between both situations.Furthermore, it will not be strange if hypertension medications serves as a frame for fictional works in the near future.

Other narrative plays were based on historical epidemics, such as Daniel Defoe’s A Journal of the Plague Year or Giovanni Boccaccio’s Decameron (Wigand, Becker, and Steger 2020. Withington 2020). The biggest lasix in the last century, the so-called ‘Spanish Influenza’, has been described as not very fruitful in this sense, even if it produced famous novels such as Katherine A Porter’s Pale Horse, Pale Rider or intravenous lasix John O’Hara’s The Doctor Son (Honigsbaum 2018.

Hovanec 2011). The overlapping with another disaster like World War I has been argued as one of the reasons explaining this scarce production of fictional works (Honigsbaum 2018). By contrast, we may think that hypertension medications is having a global impact hardly overshadowed by other events, and that it will leave a significant mark on the collective memory.Drawing on the reading of La Peste, we point out in this essay different aspects of living under intravenous lasix an epidemic that can be identified both in Camus’s work and in our current situation.

We propose a trip throughout the novel, from its early beginning in Part I, when the Oranians are not aware of the threat to come, to its end in Part V, when they are relieved of the epidemic after several months of ravaging disasters.We think this journey along La Peste may be interesting both to health professionals and to the lay person, since all of them will be able to see themselves reflected in the characters from the novel. We do not skip critique of some aspects related to the authorities’ management of hypertension medications, as Camus does concerning Oran’s rulers. However, what we want to foreground is La Peste’s intrinsic value, its suitability to be read now and after hypertension medications has passed, when Camus’s novel endures as a solid art work and hypertension medications remains only as a defeated plight.MethodsWe confronted our own experiences about hypertension medications with a conventional reading of intravenous lasix La Peste.

A first reading of the novel was used to establish associations between those aspects which more saliently reminded us of hypertension medications. In a second reading, we searched for some examples to illustrate those aspects and tried to detect new associations. Subsequent readings of intravenous lasix certain parts were done to integrate the information collected.

Neither specific methods of literary analysis, nor systematic searches in the novel were applied. Selected paragraphs and ideas from Part I to Part V were prepared in a draft copy, and this manuscript was written afterwards.Part ISome phrases in the novel could be transposed word by word to our situation. This one pertaining to its start, for instance, may make us remember the first months of 2020:By now, it will be easy to accept that nothing could lead the people of our town to expect the events that took place in the spring of that year and which, as we later understood, were like the forerunners of the series of grave happenings that intravenous lasix this history intends to describe.

(Camus 2002, Part I)By referring from the beginning to ‘the people of our town’, Camus is already suggesting an idea which is repeated all along the novel, and which may be well understood by us as hypertension medications’s witnesses. Epidemics affect the community as a whole, they are present in everybody’s mind and their joys and sorrows are not individual, but collective. For example (and we are anticipating Part II), the narrator says:But, once the gates intravenous lasix were closed, they all noticed that they were in the same boat, including the narrator himself, and that they had to adjust to the fact.

(Camus 2002, Part II)Later, he will insist in this opposition between the concepts of ‘individual’, which used to prevail before the epidemic, and ‘collective’:One might say that the first effect of this sudden and brutal attack of the disease was to force the citizens of our town to act as though they had no individual feelings. (Camus 2002, Part II)There were no longer any individual destinies, but a collective history that was the plague, and feelings shared by all. (Camus 2002, Part III)This distinction is not trivial, since the intravenous lasix story will display a strong confrontation between those who get involved and help their neighbours and those who remain behaving selfishly.

Related to this, Claudia Bozzaro has pointed out that the main topic in La Peste is solidarity and auistic love (Bozzaro 2018). We may add that the disease is so attached to people’s lives that the epidemic becomes the new everyday life:In the morning, they would return to the pestilence, that is to say, to routine. (Camus 2002, Part III)Being collective issues does not mean that epidemics always enhance auism and solidarity intravenous lasix.

As said by Wigand et al, they frequently produce ambivalent reactions, and one of them is the opposition between auism and maximised profit (Wigand, Becker, and Steger 2020). Therefore, the dichotomy between individualism and collectivism, a central point in the characterisation of national cultures (Hofstede 2015), could play a role in epidemics. In fact, concerning hypertension medications, some authors have described a intravenous lasix greater impact of the lasix in those countries with higher levels of individualism (Maaravi et al.

However, this finding should be complemented with other national cultures’ aspects before concluding that collectivism itself exerts a protective role against epidemics. Concerning this, it has been shown how ‘power distance’ frequently intersects with collectivism, being only a few countries in which the last one coexists with a small distance to power, namely with a capacity to disobey the power authority (Gupta, Shoja, and Mikalef 2021). Moreover, those countries classically classified as ‘collectivist’ (China, Japan, South Korea, India, Vietnam, etc.) are also characterised by high levels of power distance, and their citizens have been quite often forced to adhere to hypertension medications restrictions and punished if not (Gupta, Shoja, and Mikalef 2021).

Thus, it is important to consider that individualism is not always opposed to ‘look after each other’ (Ozkan et al. 2021, 9). For instance, the European region, seen as a whole as highly ‘individualistic’, holds some of the most advanced welfare protection systems worldwide.

It is worth considering too that collectivism may hide sometimes a hard institutional authority or a lack in civil freedoms.Coming back to La Peste, we may think that Camus’s Oranians are not particularly ‘collectivist’. Their initial description highlights that they are mainly interested in their own businesses and affairs:Our fellow-citizens work a good deal, but always in order to make money. They are especially interested in trade and first of all, as they say, they are engaged in doing business.

(Camus 2002, Part I)And later, we see some of them trying selfishly to leave the city by illegal methods. By contrast, we observe in the novel some examples of more ‘collectivistic’ attitudes, such as the discipline of those quarantined at the football pitch, and, over all, the main characters’ behaviour, which is generally driven by auism and common goals.Turning to another topic, the plague in Oran and hypertension medications are similar regarding their animal origin. This is not rare since many infectious diseases pass to humans through contact with animal vectors, being rodents, especially rats (through rat fleas), the most common carriers of plague bacteria (CDC.

N.d.a, ECDC. N.d, Pollitzer 1954). Concerning hypertension, even if further research about its origin is needed, the most recent investigations conducted in China by the WHO establish a zoonotic transmission as the most probable pathway (Joint WHO-China Study Team 2021).

In Camus’s novel, the animal’s link to the epidemic seemed very clear since the beginning:Things got to the point where Infodoc (the agency for information and documentation, ‘ all you need to know on any subject’) announced in its free radio news programme that 6,231 rats had been collected and burned in a single day, the 25th. This figure, which gave a clear meaning to the daily spectacle that everyone in town had in front of their eyes, disconcerted them even more. (Camus 2002, Part I)This accuracy in figures is familiar to us.

People nowadays have become very used to the statistical aspects of the lasix, due to the continuous updates in epidemiological parameters launched by the media and the authorities. Camus was aware about the relevance of figures in epidemics, which always entail:…required registration and statistical tasks. (Camus 2002, Part II)Because of this, the novel is scattered with numbers, most of them concerning the daily death toll, but others mentioning the number of rats picked up, as we have seen, or combining the number of deaths with the time passed since the start of the epidemic:“ Will there be an autumn of plague?.

Professor B answers. €˜ No’ ”, “ One hundred and twenty-four dead. The total for the ninety-fourth day of the plague.” (Camus 2002, Part II)We permit ourselves to introduce here a list of recurring topics in La Peste, since the salience of statistical information is one of them.

These topics, some of which will be treated later, appear several times in the novel, in various contexts and stages in the evolution of the epidemic. We synthesise them in Table 1, coupled with a hypertension medications parallel example extracted from online press. This ease to find a current example for each topic suggests that they are not exclusive of plague or of Camus’s mindset, but shared by most epidemics.View this table:Table 1 Recurring topics in La Peste.

Each topic is accompanied by two examples from the novel and one concerning hypertension medications, extracted from online press.Talking about journalism and the media (one of the topics above), we might say that hypertension medications’s coverage is frequently too optimistic when managing good news and too alarming when approaching the bad. Media’s ‘exaggerated’ approach to health issues is not new. It was already a concern for medical journals’ editors a century ago (Reiling 2013) and it continues to be it for these professionals in recent times (Barbour et al.

2008). It is well known that media tries to attract spectators’ attention by making the news more appealing. However, they deal with the risk of expanding unreliable information, which may be pernicious for the public opinion.

Related to the intention of ‘garnishing’ the news, Aslam et al. (2020) have described that 82% of more than 100 000 pieces of information about hypertension medications appearing in media from different countries carried an emotional, either negative (52%) or positive (30%) component, with only 18% of them considered as ‘neutral’ (Aslam et al. 2020).

Some evidence about this tendency to make news more emotional was described in former epidemics. For instance, a study conducted in Singapore in 2009 during the H1N1 crisis showed how press releases by the Ministry of Health were substantially transformed when passed to the media, by increasing their emotional appeal and by changing their dominant frame or their tone (Lee and Basnyat 2013). In La Peste, this superficial way of managing information by the media is also observed:The newspapers followed the order that they had been given, to be optimistic at any cost.

(Camus 2002, Part IV)At the first stages of the epidemic in Oran, journalists proclaim the end of the dead rats’ invasion as something to be celebrated. Dr Rieux, the character through which Camus symbolises caution (and comparable nowadays to trustful scientists, well-informed journalists or sensible authorities), exposes then his own angle, quite far from suggesting optimism:The vendors of the evening papers were shouting that the invasion of rats had ended. But Rieux found his patient lying half out of bed, one hand on his belly and the other around his neck, convulsively vomiting reddish bile into a rubbish bin.

(Camus 2002, Part I)Camus, who worked as a journalist for many years, insists afterwards on this cursory interest that some media devote to the epidemic, more eager to grab the noise than the relevant issues beneath it:The press, which had had so much to say about the business of the rats, fell silent. This is because rats die in the street and people in their bedrooms. And newspapers are only concerned with the street.

(Camus 2002, Part I)By then, Oranians continue rejecting the epidemic as an actual threat, completely immersed in that phase that dominates the beginning of all epidemics and is characterised by ‘denial and disbelief’ (Wigand, Becker, and Steger 2020, 443):A pestilence does not have human dimensions, so people tell themselves that it is unreal, that it is a bad dream which will end. […] The people of our town were no more guilty than anyone else, they merely forgot to be modest and thought that everything was still possible for them, which implied that pestilence was impossible. They continued with business, with making arrangements for travel and holding opinions.

Why should they have thought about the plague, which negates the future, negates journeys and debate?. They considered themselves free and no one will ever be free as long as there is plague, pestilence and famine. (Camus 2002, Part I)Probably to avoid citizens' disapproval, among other reasons, the Oranian Prefecture (health authority in Camus' novel) does not want to go too far when judging the relevance of the epidemic.

While not directly exposed, we can guess in this fragment the tone of the Prefect’s message, his intention to convey confidence despite his own doubts:These cases were not specific enough to be really disturbing and there was no doubt that the population would remain calm. None the less, for reasons of caution which everyone could understand, the Prefect was taking some preventive measures. If they were interpreted and applied in the proper way, these measures were such that they would put a definite stop to any threat of epidemic.

As a result, the Prefect did not for a moment doubt that the citizens under his charge would co-operate in the most zealous manner with what he was doing. (Camus 2002, Part I)The relevant role acquired by health authorities during epidemics is another topic listed in our table. Language use, on the other hand, is an issue linkable both with the media topic and with this one.

As in La Peste, during hypertension medications we have seen some public figures using words not always truthfully, carrying out a careful selection of words that serves to the goal of conveying certain interests in each moment. Dr Rieux refers in Part I to this language manipulation by the authorities:The measures that had been taken were insufficient, that was quite clear. As for the ‘ specially equipped wards’, he knew what they were.

Two outbuildings hastily cleared of other patients, their windows sealed up and the whole surrounded by a cordon sanitaire. (Camus 2002, Part I)He illustrates the need of frankness, the preference for clarity in language, which is often the clarity in thinking:No. I phoned Richard to say we needed comprehensive measures, not fine words, and that either we must set up a real barrier to the epidemic, or nothing at all.

(Camus 2002, Part I)At the end of this part, his fears about the inadequacy of not taking strict measures are confirmed. Oranian hospitals become overwhelmed, as they are now in many places worldwide due to hypertension medications.Part IILeft behind the phases of ‘denial and disbelief’ and of ‘fear and panic’, it appears among the Oranians the ‘acceptance paired with resignation’ (Wigand, Becker, and Steger 2020, 443):Then we knew that our separation was going to last, and that we ought to try to come to terms with time. […] In particular, all of the people in our town very soon gave up, even in public, whatever habit they may have acquired of estimating the length of their separation.

(Camus 2002, Part II)In hypertension medications as well, even if border closure has not been so immovable as in Oran, many people have seen themselves separated from their loved ones and some of them have not yet had the possibility of reunion. This is why, in the actual lasix, the idea of temporal horizons has emerged like it appeared in Camus’s epidemic. In Spain, the general lockdown in March and April 2020 made people establish the summer as their temporal horizon, a time in which they could resume their former habits and see their relatives again.

This became partially true, and people were allowed in summer to travel inside the country and to some other countries nearby. However, there existed some reluctance to visit ill or aged relatives, due to the fear of infecting them, and some families living in distant countries were not able to get together. Moreover, autumn brought an increase in the number of cases (‘the second wave’) and countries returned to limit their internal and external movements.Bringing all this together, many people nowadays have opted to discard temporal horizons.

As Oranians, they have noted that the epidemic follows its own rhythm and it is useless to fight against it. Nonetheless, it is in human nature not to resign, so abandoning temporal horizons does not mean to give up longing for the recovery of normal life. This vision, neither maintaining vain hopes nor resigning, is in line with Camus’s philosophy, an author who wrote that ‘hope, contrary to what it is usually thought, is the same to resignation.’ (Camus 1939, 83.

Cited by Haroutunian 1964, 312 (translation is ours)), and that ‘there is not love to human life but with despair about human life.’ (Camus 1958, 112–5. Cited by Haroutunian 1964, 312–3 (translation is ours)).People nowadays deal with resignation relying on daily life pleasures (being not allowed to make further plans or trips) and in company from the nearest ones (as they cannot gather with relatives living far away). Second, they observe the beginning of vaccination campaigns as a first step of the final stage, and summer 2021, reflecting what happened with summer 2020, has been fixed as a temporal horizon.

This preference for summers has an unavoidable metaphorical nuance, and their linking to joy, long trips and life in the streets may be the reason for which we choose them to be opposed to the lockdown and restrictions of the lasix.We alluded previously to the manipulation of language, and figures, as relevant as they are, they are not free from manipulation either. Tarrou, a close friend to Dr Rieux, points out in this part of the novel how this occurred:Once more, Tarrou was the person who gave the most accurate picture of our life as it was then. Naturally he was following the course of the plague in general, accurately observing that a turning point in the epidemic was marked by the radio no longer announcing some hundreds of deaths per week, but 92, 107 and 120 deaths a day.

€˜The newspapers and the authorities are engaged in a battle of wits with the plague. They think that they are scoring points against it, because 130 is a lower figure than 910.’ (Camus 2002, Part II)Tarrou collaborates with the health teams formed to tackle the plague. Regarding these volunteers and workers, Camus refuses to consider them as heroes, as many essential workers during hypertension medications have rejected to be named as that.

The writer thinks their actions are the natural behaviour of good people, not heroism but ‘a logical consequence’:The whole question was to prevent the largest possible number of people from dying and suffering a definitive separation. There was only one way to do this, which was to fight the plague. There was nothing admirable about this truth, it simply followed as a logical consequence.

(Camus 2002, Part II)We consider suitable to talk here about two issues which represent, nowadays, a great part of hypertension medications fears and hopes, respectively. New genetic variants and treatments. Medical achievements are another recurrent issue included in table 1, and we write about them here because it is in Part II where Camus writes for the first time about treatments, and where it insists on an idea aforementioned in Part I.

That the plague bacillus affecting Oran is different from previous variants:…the microbe differed very slightly from the bacillus of plague as traditionally defined. (Camus 2002, Part II)Related to hypertension medications new variants, they represent a challenge because of two main reasons. Their higher transmissibility and/or severity and their higher propensity to skip the effect of natural or treatment-induced immunity.

Public health professionals are determining which is the actual threat of all the new variants discovered, such as those first characterised in the UK (Public Health England 2020), South Africa (Tegally et al. 2021) or Brazil (Fujino et al. 2021).

In La Peste, Dr Rieux is always suspecting that the current bacteria they are dealing with is different from the one in previous epidemics of plague. Since several genetic variations for the bacillus Yersinia pestis have been characterised (Cui et al. 2012), it could be possible that the epidemic in Oran originated from a new one.

However, we should not forget that we are analysing a literary work, and that scientific accuracy is not a necessary goal in it. In fact, Rieux’s reluctances have to do more with clinical aspects than with microbiological ones. He doubts since the beginning, relying exclusively on the symptoms observed, and continues doing it after the laboratory analysis:I was able to have an analysis made in which the laboratory thinks it can detect the plague bacillus.

However, to be precise, we must say that certain specific modifications of the microbe do not coincide with the classic description of plague. (Camus 2002, Part II)Camus is consistent with this idea and many times he mentions the bacillus to highlight its oddity. Insisting on the literary condition of the work, and among other possible explanations, he is maybe declaring that that in the novel is not a common (biological, natural) bacteria, but the Nazism bacteria.Turning to treatments, they constitute the principal resource that the global community has to defeat the hypertension medications lasix.

Vaccination campaigns have started all over the world, and three types of hypertension medications treatments are being applied in the European Union, after their respective statements of efficacy and security (Baden et al. 2021. Polack et al.

2020. Voysey et al. 2021), while a fourth treatment has just recently been approved (EMA 2021a).

Although some concerns regarding the safety of two of these treatments have been raised recently (EMA 2021b. EMA 2021c), vaccination plans are going ahead, being adapted according to the state of knowledge at each moment. Some of these treatments are mRNA-based (Baden et al.

2021. Polack et al. 2020), while others use a viral vector (Bos et al.

They are mainly two-shot treatments, with one exception (Bos et al. 2020), and complete immunity is thought to be acquired 2 weeks after the last shot (CDC. N.d.b, Voysey et al.

2021). Other countries such as China or Russia, on the other hand, were extremely early in starting their vaccination campaigns, and are distributing among their citizens different treatments than the aforementioned (Logunov et al. 2021.

Zhang et al. 2021).Even if at least three types of plague treatments had been created by the time the novel takes place (Sun 2016), treatments do not play an important role in La Peste, in which therapeutic measures (the serum) are more important than prophylactic ones. Few times in the novel the narrator refers to prophylactic inoculations:There was still no possibility of vaccinating with preventive serum except in families already affected by the disease.

(Camus 2002, Part II)Deudon has pointed out that Camus mixes up therapeutic serum and treatment (Deudon 1988), and in fact there exists a certain amount of confusion. All along the novel, the narrator focuses on the prophylactic goals of the serum, which is applied to people already infected (Othon’s son, Tarrou, Grand…). However, both in the example above (which can be understood as vaccinating household contacts or already affected individuals) and in others, the differences between treating and vaccinating are not clear:After the morning admissions which he was in charge of himself, the patients were vaccinated and the swellings lanced.

(Camus 2002, Part II)In any case, this is another situation in which Camus stands aside from scientific matters, which are to him less relevant in his novel than philosophical or literary ones. The distance existing between the relevance of treatments in hypertension medications and the superficial manner with which Camus treats the topic in La Peste exemplifies this.Part IIIIn part III, the plague’s ravages become tougher. The narrator turns his focus to burials and their disturbance, a frequent topic in epidemics’ narrative (table 1).

Camus knew how acutely increasing demands and hygienic requirements affect funeral habits during epidemics:Everything really happened with the greatest speed and the minimum of risk. (Camus 2002, Part III)Like many other processes during epidemics, the burial process becomes a protocol. When protocolised, everything seems to work well and rapidly.

But this perfect mechanism is the Prefecture’s goal, not Rieux’s. He reveals in this moment an aspect in his character barely shown before. Irony.The whole thing was well organized and the Prefect expressed his satisfaction.

He even told Rieux that, when all was said and done, this was preferable to hearses driven by black slaves which one read about in the chronicles of earlier plagues. €˜ Yes,’ Rieux said. €˜ The burial is the same, but we keep a card index.

No one can deny that we have made progress.’ (Camus 2002, Part III)Even if this characteristic may seem new in Dr Rieux, we must bear in mind that he is the story narrator, and the narration is ironic from time to time. For instance, speaking precisely about the burials:The relatives were invited to sign a register –which just showed the difference that there may be between men and, for example, dogs. You can keep check of human beings-.

(Camus 2002, Part III)In Camus’s philosophy, the absurd is a core issue. According to Lengers, Rieux is ironic because he is a kind of Sisyphus who has understood the absurdity of plague (Lengers 1994). The response to the absurd is to rebel (Camus 2013), and Rieux does it by helping his fellow humans without questioning anything.

He does not pursue any other goal than doing his duty, thus humour (as a response to dire situations) stands out from him when he observes others celebrating irrelevant achievements, such as the Prefect with his burial protocol. In the field of medical ethics, Lengers has highlighted the importance of Camus’s perspective when considering ‘the immediacy of life rather than abstract values’ (Lengers 1994, 250). Rieux himself is quite sure that his solid commitment is not ‘abstract’, and, even if he falls into abstraction, the importance relies on protecting human lives and not in the name given to that task:Was it truly an abstraction, spending his days in the hospital where the plague was working overtime, bringing the number of victims up to five hundred on average per week?.

Yes, there was an element of abstraction and unreality in misfortune. But when an abstraction starts to kill you, you have to get to work on it. (Camus 2002, Part II)Farewells during hypertension medications may have not been particularly pleasant for some families.

Neither those dying at nursing homes nor in hospitals could be accompanied by their families as previously, due to corpses management protocols, restrictions of external visitors and hygienic measures in general. However, as weeks passed by, certain efforts were made to ease this issue, allowing people to visit their dying beloved sticking to strict preventive measures. On the other hand, the number of people attending funeral masses and cemeteries was also limited, which affected the conventional development of ceremonies as well.

Hospitals had to deal with daily tolls of deaths never seen before, and the overcrowding of mortuaries made us see rows of coffins placed in unusual spaces, such as ice rinks (transformation of facilities is another topic in table 1).We turn now to two other points which hypertension medications has not evaded. s among essential workers and epidemics’ economic consequences. The author links burials with s among essential workers because gravediggers constitute one of the most affected professions, and connects this fact with the economic recession because unemployment is behind the large availability of workers to replace the dead gravediggers:Many of the male nurses and the gravediggers, who were at first official, then casual, died of the plague.

[…] The most surprising thing was that there was never a shortage of men to do the job, for as long as the epidemic lasted. […] When the plague really took hold of the town, its very immoderation had one quite convenient outcome, because it disrupted the whole of economic life and so created quite a large number of unemployed. […] Poverty always triumphed over fear, to the extent that work was always paid according to the risk involved.

(Camus 2002, Part III)The effects of the plague over the economic system are one of our recurrent topics (table 1). The plague in Oran, as it forces to close the city, impacts all trading exchanges. In addition, it forbids travellers from arriving to the city, with the economic influence that that entails:This plague was the ruination of tourism.

(Camus 2002, Part II)Oranians, who, as we saw, were very worried about making money, are especially affected by an event which jeopardises it. In hypertension medications, for one reason or for another, most of the countries are suffering economic consequences, since the impact on normal life from the epidemic (another recurrent topic) means also an impact on the normal development of trading activities.Part IVIn Part IV we witness the first signals of a stabilisation of the epidemic:It seemed that the plague had settled comfortably into its peak and was carrying out its daily murders with the precision and regularity of a good civil servant. In theory, in the opinion of experts, this was a good sign.

The graph of the progress of the plague, starting with its constant rise, followed by this long plateau, seemed quite reassuring. (Camus 2002, Part IV)At this time, we consider interesting to expand the topic about the transformation of facilities. We mentioned the case of ice rinks during hypertension medications, and we bring up now the use of a football pitch as a quarantine camp in Camus’s novel, a scene which has reminded some scholars of the metaphor of Nazism and concentration camps (Finel-Honigman 1978).

In Spain, among other measures, a fairground was enabled as a field hospital during the first wave, and it is plausible that many devices created with other purposes were used in tasks attached to healthcare provision during those weeks, as occurred in Oran’s pitch with the loudspeakers:Then the loudspeakers, which in better times had served to introduce the teams or to declare the results of games, announced in a tinny voice that the internees should go back to their tents so that the evening meal could be distributed. (Camus 2002, Part IV)Related to this episode, we can also highlight the opposition between science and humanism that Camus does. The author alerts us about the dangers of a dehumanised science, of choosing procedures perfectly efficient regardless of their lack in human dignity:The men held out their hands, two ladles were plunged into two of the pots and emerged to unload their contents onto two tin plates.

The car drove on and the process was repeated at the next tent.‘ It’s scientific,’ Tarrou told the administrator.‘ Yes,’ he replied with satisfaction, as they shook hands. €˜ It’s scientific.’ (Camus 2002, Part IV)Several cases with favourable outcomes mark Part IV final moments and prepare the reader for the end of the epidemic. To describe these signs of recovering, the narrator turns back to two elements with a main role in the novel.

Rats and figures. In this moment, the first ones reappear and the second ones seem to be declining:He had seen two live rats come into his house through the street door. Neighbours had informed him that the creatures were also reappearing in their houses.

Behind the walls of other houses there was a hustle and bustle that had not been heard for months. Rieux waited for the general statistics to be published, as they were at the start of each week. They showed a decline in the disease.

(Camus 2002, Part IV)Part VGiven that we continue facing hypertension medications, and that forecasts about its end are not easy, we cannot compare ourselves with the Oranians once they have reached the end of the epidemic, what occurs in this part. However, we can analyse our current situation, characterised by a widespread, though cautious, confidence motivated by the beginning of vaccination campaigns, referring it to the events narrated in Part V.Even more than the Oranians, since we feel further than them from the end of the problem, we are cautious about not to anticipate celebrations. From time to time, however, we lend ourselves to dream relying on what the narrator calls ‘a great, unadmitted hope’.

hypertension medications took us by surprise and everyone wants to ‘reorganise’ their life, as Oranians do, but patience is an indispensable component to succeed, as fictional and historical epidemics show us.Although this sudden decline in the disease was unexpected, the towns-people were in no hurry to celebrate. The preceding months, though they had increased the desire for liberation, had also taught them prudence and accustomed them to count less and less on a rapid end to the epidemic. However, this new development was the subject of every conversation and, in the depths of people’s hearts, there was a great, unadmitted hope.

[…] One of the signs that a return to a time of good health was secretly expected (though no one admitted the fact) was that from this moment on people readily spoke, with apparent indifference, about how life would be reorganized after the plague. (Camus 2002, Part V)We put our hope on vaccination. Social distancing and other hygienic measures have proved to be effective, but treatments would bring us a more durable solution without compromising so hardly many economic activities and social habits.

As we said, a more important role of scientific aspects is observed in hypertension medications if compared with La Peste (an expected fact if considered that Camus’s story is an artistic work, that he skips sometimes the most complex scientific issues of the plague and that health sciences have evolved substantially during last decades). Oranians, in fact, achieve the end of the epidemic not through clearly identified scientific responses but with certain randomness:All one could do was to observe that the sickness seemed to be going as it had arrived. The strategy being used against it had not changed.

It had been ineffective yesterday, and now it was apparently successful. One merely had the feeling that the disease had exhausted itself, or perhaps that it was retiring after achieving all its objectives. In a sense, its role was completed.

(Camus 2002, Part V)They receive the announcement made by the Prefecture of reopening the town’s gates in 2 weeks time with enthusiasm. Dealing with concrete dates gives them certainty, helps them fix the temporal horizons we wrote about. This is also the case when they are told that preventive measures would be lifted in 1 month.

Camus shows us then how the main characters are touched as well by this positive atmosphere:That evening Tarrou and Rieux, Rambert and the rest, walked in the midst of the crowd, and they too felt they were treading on air. Long after leaving the boulevards Tarrou and Rieux could still hear the sounds of happiness following them… (Camus 2002, Part V)Then, Tarrou points out a sign of recovery coming from the animal world. In a direct zoological chain, infected fleas have vanished from rats, which have been able again to multiply across the city, making the cats abandon their hiding places and to go hunting after them again.

At the final step of this chain, Tarrou sees the human being. He remembers the old man who used to spit to the cats beneath his window:At a time when the noise grew louder and more joyful, Tarrou stopped. A shape was running lightly across the dark street.

It was a cat, the first that had been seen since the spring. It stopped for a moment in the middle of the road, hesitated, licked its paw, quickly passed it across its right ear, then carried on its silent way and vanished into the night. Tarrou smiled.

The little old man, too, would be happy. (Camus 2002, Part V)Unpleasant things as a town with rats running across its streets, or a man spending his time spitting on a group of cats, constitute normality as much as the reopening of gates or the reboot of commerce. However, when Camus speaks directly about normality, he highlights more appealing habits.

He proposes common leisure activities (restaurants, theatres) as symbols of human life, since he opposes them to Cottard’s life, which has become that of a ‘wild animal’:At least in appearance he [ Cottard ] retired from the world and from one day to the next started to live like a wild animal. He no longer appeared in restaurants, at the theatre or in his favourite cafés. (Camus 2002, Part V)We do not disclose why Cottard’s reaction to the end of the epidemic is different from most of the Oranians’.

In any case, the narrator insists later on the assimilation between common pleasures and normality:‘ Perhaps,’ Cottard said, ‘ Perhaps so. But what do you call a return to normal life?. €™ ‘ New films in the cinema,’ said Tarrou with a smile.

(Camus 2002, Part V)Cinema, as well as theatre, live music and many other cultural events have been cancelled or obliged to modify their activities due to hypertension medications. Several bars and restaurants have closed, and spending time in those who remain open has become an activity which many people tend to avoid, fearing contagion. Thus, normality in our understanding is linked as well to these simple and pleasant habits, and the complete achievement of them will probably signify for us the desired defeat of the lasix.In La Peste, love is also seen as a simple good to be fully recovered after the plague.

While Rieux goes through the ‘reborn’ Oran, it is lovers’ gatherings what he highlights. Unlike them, everyone who, during the epidemic, sought for goals different from love (such as faith or money, for instance) remain lost when the epidemic has ended:For all the people who, on the contrary, had looked beyond man to something that they could not even imagine, there had been no reply. (Camus 2002, Part V)And this is because lovers, as the narrator says:If they had found that they wanted, it was because they had asked for the only thing that depended on them.

(Camus 2002, Part V)We have spoken before about language manipulation, hypocrisy and public figures’ roles during epidemics. Camus, during Dr Rieux’s last visit to the old asthmatic man, makes this frank and humble character criticise, with a point of irony, the authorities’ attitude concerning tributes to the dead:‘ Tell me, doctor, is it true that they’re going to put up a monument to the victims of the plague?. €™â€˜ So the papers say.

A pillar or a plaque.’‘ I knew it!. And there’ll be speeches.’The old man gave a strangled laugh.‘ I can hear them already. €œ Our dead…” Then they’ll go and have dinner.’ (Camus 2002, Part V)The old man illustrates wisely the authorities’ propensity for making speeches.

He knows that most of them usually prefer grandiloquence rather than common words, and seizes perfectly their tone when he imitates them (‘Our dead…’). We have also got used, during hypertension medications, to these types of messages. We have also heard about ‘our old people’, ‘our youth’, ‘our essential workers’ and even ‘our dead’.

Behind this tone, however, there could be an intention to hide errors, or to falsely convey carefulness. Honest rulers do not usually need nice words. They just want them to be accurate.We have seen as well some tributes to the victims during hypertension medications, some of which we can doubt whether they serve to victims’ relief or to authorities’ promotion.

We want rulers to be less aware of their own image and to stress truthfulness as a goal, even if this is a hard requirement not only for them, but for every single person. Language is essential in this issue, we think, since it is prone to be twisted and to become untrue. The old asthmatic man illustrates it with his ‘There’ll be speeches’ and his ‘Our dead…’, but this is not the only time in the novel in which Camus brings out the topic.

For instance, he does so when he equates silence (nothing can be thought as further from wordiness) with truth:It is at the moment of misfortune that one becomes accustomed to truth, that is to say to silence. (Camus 2002, Part II)or when he makes a solid statement against false words:…I understood that all the misfortunes of mankind came from not stating things in clear terms. (Camus 2002, Part IV)The old asthmatic, in fact, while praising the deceased Tarrou, remarks that he used to admire him because ‘he didn’t talk just for the sake of it.’ (Camus 2002, Part V).Related to this topic, what the old asthmatic says about political authorities may be transposed in our case to other public figures, such as scholars and researchers, media leaders, businessmen and women, health professionals… and, if we extend the scope, to every single citizen.

Because hypocrisy, language manipulation and the fact of putting individual interests ahead of collective welfare fit badly with collective issues such as epidemics. Hopefully, also examples to the contrary have been observed during hypertension medications.The story ends with the fireworks in Oran and the depiction of Dr Rieux’s last feelings. While he is satisfied because of his medical performance and his activity as a witness of the plague, he is concerned about future disasters to come.

When hypertension medications will have passed, it will be time for us as well to review our life during these months. For now, we are just looking forward to achieving our particular ‘part V’.AbstractThis study addresses the existing gap in literature that ethnographically examines the experiences of Spanish-speaking patients with limited English proficiency in clinical spaces. All of the participants in this study presented to the emergency department (ED) for evaluation of non-urgent health conditions.

Patient shadowing was employed to explore the challenges that this population face in unique clinical settings like the ED. This relatively new methodology facilitates obtaining nuanced understandings of clinical contexts under study in ways that quantitative approaches and survey research do not. Drawing from the field of medical anthropology and approach of narrative medicine, the collected data are presented through the use of clinical ethnographic vignettes and thick description.

The conceptual framework of health-related deservingness guided the analysis undertaken in this study. Structural stigma was used as a complementary framework in analysing the emergent themes in the data collected. The results and analysis from this study were used to develop an argument for the consideration of language as a distinct social determinant of health.emergency medicinemedical anthropologymedical humanitiesData availability statementData sharing not applicable as no datasets were generated and/or analysed for this study..

IntroductionLa Peste (Camus 1947) has served as a basis for how much lasix cost several critical works, including some in the look at this now field of medical humanities (Bozzaro 2018. Deudon 1988. Tuffuor and how much lasix cost Payne 2017). Frequently interpreted as an allegory of Nazism (with the plague as a symbol of the German occupation of France) (Finel-Honigman 1978.

Haroutunian 1964), it has also received philosophical readings beyond the sociopolitical context in which it was written (Lengers 1994). Other scholars, on the other hand, have centred their how much lasix cost analyses on its literary aspects (Steel 2016).The hypertension medications lasix has increased general interest about historical and fictional epidemics. La Peste, as one of the most famous literary works about this topic, has been revisited by many readers during recent months, leading to an unexpected growth in sales in certain countries (Wilsher 2020. Zaretsky 2020).

Apart from that, commentaries about the novel, how much lasix cost especially among health sciences scholars, have emerged with a renewed interest (Banerjee et al. 2020. Bate 2020. Vandekerckhove 2020 how much lasix cost.

Wigand, Becker, and Steger 2020). This sudden curiosity is easy to understand if we consider both La Peste’s literary value, and people’s desire to discover real or fictional situations similar to theirs. Indeed, Oran inhabitants’ experiences are not quite far from our own, even if geographical, chronological and, specially, scientific factors (two different diseases occurring at two different stages in the history of medical development) prevent us from establishing too close resemblances between both situations.Furthermore, it will not be strange if hypertension medications serves how much lasix cost as a frame for fictional works in the near future. Other narrative plays were based on historical epidemics, such as Daniel Defoe’s A Journal of the Plague Year or Giovanni Boccaccio’s Decameron (Wigand, Becker, and Steger 2020.

Withington 2020). The biggest lasix in the last century, the so-called ‘Spanish Influenza’, has been how much lasix cost described as not very fruitful in this sense, even if it produced famous novels such as Katherine A Porter’s Pale Horse, Pale Rider or John O’Hara’s The Doctor Son (Honigsbaum 2018. Hovanec 2011). The overlapping with another disaster like World War I has been argued as one of the reasons explaining this scarce production of fictional works (Honigsbaum 2018).

By contrast, we may think that hypertension medications is having a global impact hardly overshadowed by other events, and that it will leave a significant mark on the collective memory.Drawing on the reading of La Peste, we how much lasix cost point out in this essay different aspects of living under an epidemic that can be identified both in Camus’s work and in our current situation. We propose a trip throughout the novel, from its early beginning in Part I, when the Oranians are not aware of the threat to come, to its end in Part V, when they are relieved of the epidemic after several months of ravaging disasters.We think this journey along La Peste may be interesting both to health professionals and to the lay person, since all of them will be able to see themselves reflected in the characters from the novel. We do not skip critique of some aspects related to the authorities’ management of hypertension medications, as Camus does concerning Oran’s rulers. However, what we want to foreground is La Peste’s intrinsic value, its suitability to be read now and after hypertension medications has passed, when Camus’s novel endures as a solid art work and hypertension medications remains only as how much lasix cost a defeated plight.MethodsWe confronted our own experiences about hypertension medications with a conventional reading of La Peste.

A first reading of the novel was used to establish associations between those aspects which more saliently reminded us of hypertension medications. In a second reading, we searched for some examples to illustrate those aspects and tried to detect new associations. Subsequent readings of certain parts were done how much lasix cost to integrate the information collected. Neither specific methods of literary analysis, nor systematic searches in the novel were applied.

Selected paragraphs and ideas from Part I to Part V were prepared in a draft copy, and this manuscript was written afterwards.Part ISome phrases in the novel could be transposed word by word to our situation. This one pertaining to its start, for instance, may how much lasix cost make us remember the first months of 2020:By now, it will be easy to accept that nothing could lead the people of our town to expect the events that took place in the spring of that year and which, as we later understood, were like the forerunners of the series of grave happenings that this history intends to describe. (Camus 2002, Part I)By referring from the beginning to ‘the people of our town’, Camus is already suggesting an idea which is repeated all along the novel, and which may be well understood by us as hypertension medications’s witnesses. Epidemics affect the community as a whole, they are present in everybody’s mind and their joys and sorrows are not individual, but collective.

For example (and we are anticipating Part II), the narrator says:But, once the gates were closed, they all noticed that they were in the same boat, including the narrator himself, and that they had to adjust to the how much lasix cost fact. (Camus 2002, Part II)Later, he will insist in this opposition between the concepts of ‘individual’, which used to prevail before the epidemic, and ‘collective’:One might say that the first effect of this sudden and brutal attack of the disease was to force the citizens of our town to act as though they had no individual feelings. (Camus 2002, Part II)There were no longer any individual destinies, but a collective history that was the plague, and feelings shared by all. (Camus 2002, Part III)This distinction is not trivial, since the story will display a strong confrontation between those who get involved and help their neighbours and those who how much lasix cost remain behaving selfishly.

Related to this, Claudia Bozzaro has pointed out that the main topic in La Peste is solidarity and auistic love (Bozzaro 2018). We may add that the disease is so attached to people’s lives that the epidemic becomes the new everyday life:In the morning, they would return to the pestilence, that is to say, to routine. (Camus 2002, Part III)Being collective issues does not mean that epidemics always enhance auism how much lasix cost and solidarity. As said by Wigand et al, they frequently produce ambivalent reactions, and one of them is the opposition between auism and maximised profit (Wigand, Becker, and Steger 2020).

Therefore, the dichotomy between individualism and collectivism, a central point in the characterisation of national cultures (Hofstede 2015), could play a role in epidemics. In fact, concerning hypertension medications, some authors have described a greater impact of the lasix in those countries with higher levels of individualism (Maaravi how much lasix cost et al. 2021. Ozkan et al.

2021). However, this finding should be complemented with other national cultures’ aspects before concluding that collectivism itself exerts a protective role against epidemics. Concerning this, it has been shown how ‘power distance’ frequently intersects with collectivism, being only a few countries in which the last one coexists with a small distance to power, namely with a capacity to disobey the power authority (Gupta, Shoja, and Mikalef 2021). Moreover, those countries classically classified as ‘collectivist’ (China, Japan, South Korea, India, Vietnam, etc.) are also characterised by high levels of power distance, and their citizens have been quite often forced to adhere to hypertension medications restrictions and punished if not (Gupta, Shoja, and Mikalef 2021).

Thus, it is important to consider that individualism is not always opposed to ‘look after each other’ (Ozkan et al. 2021, 9). For instance, the European region, seen as a whole as highly ‘individualistic’, holds some of the most advanced welfare protection systems worldwide. It is worth considering too that collectivism may hide sometimes a hard institutional authority or a lack in civil freedoms.Coming back to La Peste, we may think that Camus’s Oranians are not particularly ‘collectivist’.

Their initial description highlights that they are mainly interested in their own businesses and affairs:Our fellow-citizens work a good deal, but always in order to make money. They are especially interested in trade and first of all, as they say, they are engaged in doing business. (Camus 2002, Part I)And later, we see some of them trying selfishly to leave the city by illegal methods. By contrast, we observe in the novel some examples of more ‘collectivistic’ attitudes, such as the discipline of those quarantined at the football pitch, and, over all, the main characters’ behaviour, which is generally driven by auism and common goals.Turning to another topic, the plague in Oran and hypertension medications are similar regarding their animal origin.

This is not rare since many infectious diseases pass to humans through contact with animal vectors, being rodents, especially rats (through rat fleas), the most common carriers of plague bacteria (CDC. N.d.a, ECDC. N.d, Pollitzer 1954). Concerning hypertension, even if further research about its origin is needed, the most recent investigations conducted in China by the WHO establish a zoonotic transmission as the most probable pathway (Joint WHO-China Study Team 2021).

In Camus’s novel, the animal’s link to the epidemic seemed very clear since the beginning:Things got to the point where Infodoc (the agency for information and documentation, ‘ all you need to know on any subject’) announced in its free radio news programme that 6,231 rats had been collected and burned in a single day, the 25th. This figure, which gave a clear meaning to the daily spectacle that everyone in town had in front of their eyes, disconcerted them even more. (Camus 2002, Part I)This accuracy in figures is familiar to us. People nowadays have become very used to the statistical aspects of the lasix, due to the continuous updates in epidemiological parameters launched by the media and the authorities.

Camus was aware about the relevance of figures in epidemics, which always entail:…required registration and statistical tasks. (Camus 2002, Part II)Because of this, the novel is scattered with numbers, most of them concerning the daily death toll, but others mentioning the number of rats picked up, as we have seen, or combining the number of deaths with the time passed since the start of the epidemic:“ Will there be an autumn of plague?. Professor B answers. €˜ No’ ”, “ One hundred and twenty-four dead.

The total for the ninety-fourth day of the plague.” (Camus 2002, Part II)We permit ourselves to introduce here a list of recurring topics in La Peste, since the salience of statistical information is one of them. These topics, some of which will be treated later, appear several times in the novel, in various contexts and stages in the evolution of the epidemic. We synthesise them in Table 1, coupled with a hypertension medications parallel example extracted from online press. This ease to find a current example for each topic suggests that they are not exclusive of plague or of Camus’s mindset, but shared by most epidemics.View this table:Table 1 Recurring topics in La Peste.

Each topic is accompanied by two examples from the novel and one concerning hypertension medications, extracted from online press.Talking about journalism and the media (one of the topics above), we might say that hypertension medications’s coverage is frequently too optimistic when managing good news and too alarming when approaching the bad. Media’s ‘exaggerated’ approach to health issues is not new. It was already a concern for medical journals’ editors a century ago (Reiling 2013) and it continues to be it for these professionals in recent times (Barbour et al. 2008).

It is well known that media tries to attract spectators’ attention by making the news more appealing. However, they deal with the risk of expanding unreliable information, which may be pernicious for the public opinion. Related to the intention of ‘garnishing’ the news, Aslam et al. (2020) have described that 82% of more than 100 000 pieces of information about hypertension medications appearing in media from different countries carried an emotional, either negative (52%) or positive (30%) component, with only 18% of them considered as ‘neutral’ (Aslam et al.

2020). Some evidence about this tendency to make news more emotional was described in former epidemics. For instance, a study conducted in Singapore in 2009 during the H1N1 crisis showed how press releases by the Ministry of Health were substantially transformed when passed to the media, by increasing their emotional appeal and by changing their dominant frame or their tone (Lee and Basnyat 2013). In La Peste, this superficial way of managing information by the media is also observed:The newspapers followed the order that they had been given, to be optimistic at any cost.

(Camus 2002, Part IV)At the first stages of the epidemic in Oran, journalists proclaim the end of the dead rats’ invasion as something to be celebrated. Dr Rieux, the character through which Camus symbolises caution (and comparable nowadays to trustful scientists, well-informed journalists or sensible authorities), exposes then his own angle, quite far from suggesting optimism:The vendors of the evening papers were shouting that the invasion of rats had ended. But Rieux found his patient lying half out of bed, one hand on his belly and the other around his neck, convulsively vomiting reddish bile into a rubbish bin. (Camus 2002, Part I)Camus, who worked as a journalist for many years, insists afterwards on this cursory interest that some media devote to the epidemic, more eager to grab the noise than the relevant issues beneath it:The press, which had had so much to say about the business of the rats, fell silent.

This is because rats die in the street and people in their bedrooms. And newspapers are only concerned with the street. (Camus 2002, Part I)By then, Oranians continue rejecting the epidemic as an actual threat, completely immersed in that phase that dominates the beginning of all epidemics and is characterised by ‘denial and disbelief’ (Wigand, Becker, and Steger 2020, 443):A pestilence does not have human dimensions, so people tell themselves that it is unreal, that it is a bad dream which will end. […] The people of our town were no more guilty than anyone else, they merely forgot to be modest and thought that everything was still possible for them, which implied that pestilence was impossible.

They continued with business, with making arrangements for travel and holding opinions. Why should they have thought about the plague, which negates the future, negates journeys and debate?. They considered themselves free and no one will ever be free as long as there is plague, pestilence and famine. (Camus 2002, Part I)Probably to avoid citizens' disapproval, among other reasons, the Oranian Prefecture (health authority in Camus' novel) does not want to go too far when judging the relevance of the epidemic.

While not directly exposed, we can guess in this fragment the tone of the Prefect’s message, his intention to convey confidence despite his own doubts:These cases were not specific enough to be really disturbing and there was no doubt that the population would remain calm. None the less, for reasons of caution which everyone could understand, the Prefect was taking some preventive measures. If they were interpreted and applied in the proper way, these measures were such that they would put a definite stop to any threat of epidemic. As a result, the Prefect did not for a moment doubt that the citizens under his charge would co-operate in the most zealous manner with what he was doing.

(Camus 2002, Part I)The relevant role acquired by health authorities during epidemics is another topic listed in our table. Language use, on the other hand, is an issue linkable both with the media topic and with this one. As in La Peste, during hypertension medications we have seen some public figures using words not always truthfully, carrying out a careful selection of words that serves to the goal of conveying certain interests in each moment. Dr Rieux refers in Part I to this language manipulation by the authorities:The measures that had been taken were insufficient, that was quite clear.

As for the ‘ specially equipped wards’, he knew what they were. Two outbuildings hastily cleared of other patients, their windows sealed up and the whole surrounded by a cordon sanitaire. (Camus 2002, Part I)He illustrates the need of frankness, the preference for clarity in language, which is often the clarity in thinking:No. I phoned Richard to say we needed comprehensive measures, not fine words, and that either we must set up a real barrier to the epidemic, or nothing at all.

(Camus 2002, Part I)At the end of this part, his fears about the inadequacy of not taking strict measures are confirmed. Oranian hospitals become overwhelmed, as they are now in many places worldwide due to hypertension medications.Part IILeft behind the phases of ‘denial and disbelief’ and of ‘fear and panic’, it appears among the Oranians the ‘acceptance paired with resignation’ (Wigand, Becker, and Steger 2020, 443):Then we knew that our separation was going to last, and that we ought to try to come to terms with time. […] In particular, all of the people in our town very soon gave up, even in public, whatever habit they may have acquired of estimating the length of their separation. (Camus 2002, Part II)In hypertension medications as well, even if border closure has not been so immovable as in Oran, many people have seen themselves separated from their loved ones and some of them have not yet had the possibility of reunion.

This is why, in the actual lasix, the idea of temporal horizons has emerged like it appeared in Camus’s epidemic. In Spain, the general lockdown in March and April 2020 made people establish the summer as their temporal horizon, a time in which they could resume their former habits and see their relatives again. This became partially true, and people were allowed in summer to travel inside the country and to some other countries nearby. However, there existed some reluctance to visit ill or aged relatives, due to the fear of infecting them, and some families living in distant countries were not able to get together.

Moreover, autumn brought an increase in the number of cases (‘the second wave’) and countries returned to limit their internal and external movements.Bringing all this together, many people nowadays have opted to discard temporal horizons. As Oranians, they have noted that the epidemic follows its own rhythm and it is useless to fight against it. Nonetheless, it is in human nature not to resign, so abandoning temporal horizons does not mean to give up longing for the recovery of normal life. This vision, neither maintaining vain hopes nor resigning, is in line with Camus’s philosophy, an author who wrote that ‘hope, contrary to what it is usually thought, is the same to resignation.’ (Camus 1939, 83.

Cited by Haroutunian 1964, 312 (translation is ours)), and that ‘there is not love to human life but with despair about human life.’ (Camus 1958, 112–5. Cited by Haroutunian 1964, 312–3 (translation is ours)).People nowadays deal with resignation relying on daily life pleasures (being not allowed to make further plans or trips) and in company from the nearest ones (as they cannot gather with relatives living far away). Second, they observe the beginning of vaccination campaigns as a first step of the final stage, and summer 2021, reflecting what happened with summer 2020, has been fixed as a temporal horizon. This preference for summers has an unavoidable metaphorical nuance, and their linking to joy, long trips and life in the streets may be the reason for which we choose them to be opposed to the lockdown and restrictions of the lasix.We alluded previously to the manipulation of language, and figures, as relevant as they are, they are not free from manipulation either.

Tarrou, a close friend to Dr Rieux, points out in this part of the novel how this occurred:Once more, Tarrou was the person who gave the most accurate picture of our life as it was then. Naturally he was following the course of the plague in general, accurately observing that a turning point in the epidemic was marked by the radio no longer announcing some hundreds of deaths per week, but 92, 107 and 120 deaths a day. €˜The newspapers and the authorities are engaged in a battle of wits with the plague. They think that they are scoring points against it, because 130 is a lower figure than 910.’ (Camus 2002, Part II)Tarrou collaborates with the health teams formed to tackle the plague.

Regarding these volunteers and workers, Camus refuses to consider them as heroes, as many essential workers during hypertension medications have rejected to be named as that. The writer thinks their actions are the natural behaviour of good people, not heroism but ‘a logical consequence’:The whole question was to prevent the largest possible number of people from dying and suffering a definitive separation. There was only one way to do this, which was to fight the plague. There was nothing admirable about this truth, it simply followed as a logical consequence.

(Camus 2002, Part II)We consider suitable to talk here about two issues which represent, nowadays, a great part of hypertension medications fears and hopes, respectively. New genetic variants and treatments. Medical achievements are another recurrent issue included in table 1, and we write about them here because it is in Part II where Camus writes for the first time about treatments, and where it insists on an idea aforementioned in Part I. That the plague bacillus affecting Oran is different from previous variants:…the microbe differed very slightly from the bacillus of plague as traditionally defined.

(Camus 2002, Part II)Related to hypertension medications new variants, they represent a challenge because of two main reasons. Their higher transmissibility and/or severity and their higher propensity to skip the effect of natural or treatment-induced immunity. Public health professionals are determining which is the actual threat of all the new variants discovered, such as those first characterised in the UK (Public Health England 2020), South Africa (Tegally et al. 2021) or Brazil (Fujino et al.

2021). In La Peste, Dr Rieux is always suspecting that the current bacteria they are dealing with is different from the one in previous epidemics of plague. Since several genetic variations for the bacillus Yersinia pestis have been characterised (Cui et al. 2012), it could be possible that the epidemic in Oran originated from a new one.

However, we should not forget that we are analysing a literary work, and that scientific accuracy is not a necessary goal in it. In fact, Rieux’s reluctances have to do more with clinical aspects than with microbiological ones. He doubts since the beginning, relying exclusively on the symptoms observed, and continues doing it after the laboratory analysis:I was able to have an analysis made in which the laboratory thinks it can detect the plague bacillus. However, to be precise, we must say that certain specific modifications of the microbe do not coincide with the classic description of plague.

(Camus 2002, Part II)Camus is consistent with this idea and many times he mentions the bacillus to highlight its oddity. Insisting on the literary condition of the work, and among other possible explanations, he is maybe declaring that that in the novel is not a common (biological, natural) bacteria, but the Nazism bacteria.Turning to treatments, they constitute the principal resource that the global community has to defeat the hypertension medications lasix. Vaccination campaigns have started all over the world, and three types of hypertension medications treatments are being applied in the European Union, after their respective statements of efficacy and security (Baden et al. 2021.

Polack et al. 2020. Voysey et al. 2021), while a fourth treatment has just recently been approved (EMA 2021a).

Although some concerns regarding the safety of two of these treatments have been raised recently (EMA 2021b. EMA 2021c), vaccination plans are going ahead, being adapted according to the state of knowledge at each moment. Some of these treatments are mRNA-based (Baden et al. 2021.

Polack et al. 2020), while others use a viral vector (Bos et al. 2020. Voysey et al.

2021). They are mainly two-shot treatments, with one exception (Bos et al. 2020), and complete immunity is thought to be acquired 2 weeks after the last shot (CDC. N.d.b, Voysey et al.

2021). Other countries such as China or Russia, on the other hand, were extremely early in starting their vaccination campaigns, and are distributing among their citizens different treatments than the aforementioned (Logunov et al. 2021. Zhang et al.

2021).Even if at least three types of plague treatments had been created by the time the novel takes place (Sun 2016), treatments do not play an important role in La Peste, in which therapeutic measures (the serum) are more important than prophylactic ones. Few times in the novel the narrator refers to prophylactic inoculations:There was still no possibility of vaccinating with preventive serum except in families already affected by the disease. (Camus 2002, Part II)Deudon has pointed out that Camus mixes up therapeutic serum and treatment (Deudon 1988), and in fact there exists a certain amount of confusion. All along the novel, the narrator focuses on the prophylactic goals of the serum, which is applied to people already infected (Othon’s son, Tarrou, Grand…).

However, both in the example above (which can be understood as vaccinating household contacts or already affected individuals) and in others, the differences between treating and vaccinating are not clear:After the morning admissions which he was in charge of himself, the patients were vaccinated and the swellings lanced. (Camus 2002, Part II)In any case, this is another situation in which Camus stands aside from scientific matters, which are to him less relevant in his novel than philosophical or literary ones. The distance existing between the relevance of treatments in hypertension medications and the superficial manner with which Camus treats the topic in La Peste exemplifies this.Part IIIIn part III, the plague’s ravages become tougher. The narrator turns his focus to burials and their disturbance, a frequent topic in epidemics’ narrative (table 1).

Camus knew how acutely increasing demands and hygienic requirements affect funeral habits during epidemics:Everything really happened with the greatest speed and the minimum of risk. (Camus 2002, Part III)Like many other processes during epidemics, the burial process becomes a protocol. When protocolised, everything seems to work well and rapidly. But this perfect mechanism is the Prefecture’s goal, not Rieux’s.

He reveals in this moment an aspect in his character barely shown before. Irony.The whole thing was well organized and the Prefect expressed his satisfaction. He even told Rieux that, when all was said and done, this was preferable to hearses driven by black slaves which one read about in the chronicles of earlier plagues. €˜ Yes,’ Rieux said.

€˜ The burial is the same, but we keep a card index. No one can deny that we have made progress.’ (Camus 2002, Part III)Even if this characteristic may seem new in Dr Rieux, we must bear in mind that he is the story narrator, and the narration is ironic from time to time. For instance, speaking precisely about the burials:The relatives were invited to sign a register –which just showed the difference that there may be between men and, for example, dogs. You can keep check of human beings-.

(Camus 2002, Part III)In Camus’s philosophy, the absurd is a core issue. According to Lengers, Rieux is ironic because he is a kind of Sisyphus who has understood the absurdity of plague (Lengers 1994). The response to the absurd is to rebel (Camus 2013), and Rieux does it by helping his fellow humans without questioning anything. He does not pursue any other goal than doing his duty, thus humour (as a response to dire situations) stands out from him when he observes others celebrating irrelevant achievements, such as the Prefect with his burial protocol.

In the field of medical ethics, Lengers has highlighted the importance of Camus’s perspective when considering ‘the immediacy of life rather than abstract values’ (Lengers 1994, 250). Rieux himself is quite sure that his solid commitment is not ‘abstract’, and, even if he falls into abstraction, the importance relies on protecting human lives and not in the name given to that task:Was it truly an abstraction, spending his days in the hospital where the plague was working overtime, bringing the number of victims up to five hundred on average per week?. Yes, there was an element of abstraction and unreality in misfortune. But when an abstraction starts to kill you, you have to get to work on it.

(Camus 2002, Part II)Farewells during hypertension medications may have not been particularly pleasant for some families. Neither those dying at nursing homes nor in hospitals could be accompanied by their families as previously, due to corpses management protocols, restrictions of external visitors and hygienic measures in general. However, as weeks passed by, certain efforts were made to ease this issue, allowing people to visit their dying beloved sticking to strict preventive measures. On the other hand, the number of people attending funeral masses and cemeteries was also limited, which affected the conventional development of ceremonies as well.

Hospitals had to deal with daily tolls of deaths never seen before, and the overcrowding of mortuaries made us see rows of coffins placed in unusual spaces, such as ice rinks (transformation of facilities is another topic in table 1).We turn now to two other points which hypertension medications has not evaded. s among essential workers and epidemics’ economic consequences. The author links burials with s among essential workers because gravediggers constitute one of the most affected professions, and connects this fact with the economic recession because unemployment is behind the large availability of workers to replace the dead gravediggers:Many of the male nurses and the gravediggers, who were at first official, then casual, died of the plague. […] The most surprising thing was that there was never a shortage of men to do the job, for as long as the epidemic lasted.

[…] When the plague really took hold of the town, its very immoderation had one quite convenient outcome, because it disrupted the whole of economic life and so created quite a large number of unemployed. […] Poverty always triumphed over fear, to the extent that work was always paid according to the risk involved. (Camus 2002, Part III)The effects of the plague over the economic system are one of our recurrent topics (table 1). The plague in Oran, as it forces to close the city, impacts all trading exchanges.

In addition, it forbids travellers from arriving to the city, with the economic influence that that entails:This plague was the ruination of tourism. (Camus 2002, Part II)Oranians, who, as we saw, were very worried about making money, are especially affected by an event which jeopardises it. In hypertension medications, for one reason or for another, most of the countries are suffering economic consequences, since the impact on normal life from the epidemic (another recurrent topic) means also an impact on the normal development of trading activities.Part IVIn Part IV we witness the first signals of a stabilisation of the epidemic:It seemed that the plague had settled comfortably into its peak and was carrying out its daily murders with the precision and regularity of a good civil servant. In theory, in the opinion of experts, this was a good sign.

The graph of the progress of the plague, starting with its constant rise, followed by this long plateau, seemed quite reassuring. (Camus 2002, Part IV)At this time, we consider interesting to expand the topic about the transformation of facilities. We mentioned the case of ice rinks during hypertension medications, and we bring up now the use of a football pitch as a quarantine camp in Camus’s novel, a scene which has reminded some scholars of the metaphor of Nazism and concentration camps (Finel-Honigman 1978). In Spain, among other measures, a fairground was enabled as a field hospital during the first wave, and it is plausible that many devices created with other purposes were used in tasks attached to healthcare provision during those weeks, as occurred in Oran’s pitch with the loudspeakers:Then the loudspeakers, which in better times had served to introduce the teams or to declare the results of games, announced in a tinny voice that the internees should go back to their tents so that the evening meal could be distributed.

(Camus 2002, Part IV)Related to this episode, we can also highlight the opposition between science and humanism that Camus does. The author alerts us about the dangers of a dehumanised science, of choosing procedures perfectly efficient regardless of their lack in human dignity:The men held out their hands, two ladles were plunged into two of the pots and emerged to unload their contents onto two tin plates. The car drove on and the process was repeated at the next tent.‘ It’s scientific,’ Tarrou told the administrator.‘ Yes,’ he replied with satisfaction, as they shook hands. €˜ It’s scientific.’ (Camus 2002, Part IV)Several cases with favourable outcomes mark Part IV final moments and prepare the reader for the end of the epidemic.

To describe these signs of recovering, the narrator turns back to two elements with a main role in the novel. Rats and figures. In this moment, the first ones reappear and the second ones seem to be declining:He had seen two live rats come into his house through the street door. Neighbours had informed him that the creatures were also reappearing in their houses.

Behind the walls of other houses there was a hustle and bustle that had not been heard for months. Rieux waited for the general statistics to be published, as they were at the start of each week. They showed a decline in the disease. (Camus 2002, Part IV)Part VGiven that we continue facing hypertension medications, and that forecasts about its end are not easy, we cannot compare ourselves with the Oranians once they have reached the end of the epidemic, what occurs in this part.

However, we can analyse our current situation, characterised by a widespread, though cautious, confidence motivated by the beginning of vaccination campaigns, referring it to the events narrated in Part V.Even more than the Oranians, since we feel further than them from the end of the problem, we are cautious about not to anticipate celebrations. From time to time, however, we lend ourselves to dream relying on what the narrator calls ‘a great, unadmitted hope’. hypertension medications took us by surprise and everyone wants to ‘reorganise’ their life, as Oranians do, but patience is an indispensable component to succeed, as fictional and historical epidemics show us.Although this sudden decline in the disease was unexpected, the towns-people were in no hurry to celebrate. The preceding months, though they had increased the desire for liberation, had also taught them prudence and accustomed them to count less and less on a rapid end to the epidemic.

However, this new development was the subject of every conversation and, in the depths of people’s hearts, there was a great, unadmitted hope. […] One of the signs that a return to a time of good health was secretly expected (though no one admitted the fact) was that from this moment on people readily spoke, with apparent indifference, about how life would be reorganized after the plague. (Camus 2002, Part V)We put our hope on vaccination. Social distancing and other hygienic measures have proved to be effective, but treatments would bring us a more durable solution without compromising so hardly many economic activities and social habits.

As we said, a more important role of scientific aspects is observed in hypertension medications if compared with La Peste (an expected fact if considered that Camus’s story is an artistic work, that he skips sometimes the most complex scientific issues of the plague and that health sciences have evolved substantially during last decades). Oranians, in fact, achieve the end of the epidemic not through clearly identified scientific responses but with certain randomness:All one could do was to observe that the sickness seemed to be going as it had arrived. The strategy being used against it had not changed. It had been ineffective yesterday, and now it was apparently successful.

One merely had the feeling that the disease had exhausted itself, or perhaps that it was retiring after achieving all its objectives. In a sense, its role was completed. (Camus 2002, Part V)They receive the announcement made by the Prefecture of reopening the town’s gates in 2 weeks time with enthusiasm. Dealing with concrete dates gives them certainty, helps them fix the temporal horizons we wrote about.

This is also the case when they are told that preventive measures would be lifted in 1 month. Camus shows us then how the main characters are touched as well by this positive atmosphere:That evening Tarrou and Rieux, Rambert and the rest, walked in the midst of the crowd, and they too felt they were treading on air. Long after leaving the boulevards Tarrou and Rieux could still hear the sounds of happiness following them… (Camus 2002, Part V)Then, Tarrou points out a sign of recovery coming from the animal world. In a direct zoological chain, infected fleas have vanished from rats, which have been able again to multiply across the city, making the cats abandon their hiding places and to go hunting after them again.

At the final step of this chain, Tarrou sees the human being. He remembers the old man who used to spit to the cats beneath his window:At a time when the noise grew louder and more joyful, Tarrou stopped. A shape was running lightly across the dark street. It was a cat, the first that had been seen since the spring.

It stopped for a moment in the middle of the road, hesitated, licked its paw, quickly passed it across its right ear, then carried on its silent way and vanished into the night. Tarrou smiled. The little old man, too, would be happy. (Camus 2002, Part V)Unpleasant things as a town with rats running across its streets, or a man spending his time spitting on a group of cats, constitute normality as much as the reopening of gates or the reboot of commerce.

However, when Camus speaks directly about normality, he highlights more appealing habits. He proposes common leisure activities (restaurants, theatres) as symbols of human life, since he opposes them to Cottard’s life, which has become that of a ‘wild animal’:At least in appearance he [ Cottard ] retired from the world and from one day to the next started to live like a wild animal. He no longer appeared in restaurants, at the theatre or in his favourite cafés. (Camus 2002, Part V)We do not disclose why Cottard’s reaction to the end of the epidemic is different from most of the Oranians’.

In any case, the narrator insists later on the assimilation between common pleasures and normality:‘ Perhaps,’ Cottard said, ‘ Perhaps so. But what do you call a return to normal life?. €™ ‘ New films in the cinema,’ said Tarrou with a smile. (Camus 2002, Part V)Cinema, as well as theatre, live music and many other cultural events have been cancelled or obliged to modify their activities due to hypertension medications.

Several bars and restaurants have closed, and spending time in those who remain open has become an activity which many people tend to avoid, fearing contagion. Thus, normality in our understanding is linked as well to these simple and pleasant habits, and the complete achievement of them will probably signify for us the desired defeat of the lasix.In La Peste, love is also seen as a simple good to be fully recovered after the plague. While Rieux goes through the ‘reborn’ Oran, it is lovers’ gatherings what he highlights. Unlike them, everyone who, during the epidemic, sought for goals different from love (such as faith or money, for instance) remain lost when the epidemic has ended:For all the people who, on the contrary, had looked beyond man to something that they could not even imagine, there had been no reply.

(Camus 2002, Part V)And this is because lovers, as the narrator says:If they had found that they wanted, it was because they had asked for the only thing that depended on them. (Camus 2002, Part V)We have spoken before about language manipulation, hypocrisy and public figures’ roles during epidemics. Camus, during Dr Rieux’s last visit to the old asthmatic man, makes this frank and humble character criticise, with a point of irony, the authorities’ attitude concerning tributes to the dead:‘ Tell me, doctor, is it true that they’re going to put up a monument to the victims of the plague?. €™â€˜ So the papers say.

A pillar or a plaque.’‘ I knew it!. And there’ll be speeches.’The old man gave a strangled laugh.‘ I can hear them already. €œ Our dead…” Then they’ll go and have dinner.’ (Camus 2002, Part V)The old man illustrates wisely the authorities’ propensity for making speeches. He knows that most of them usually prefer grandiloquence rather than common words, and seizes perfectly their tone when he imitates them (‘Our dead…’).

We have also got used, during hypertension medications, to these types of messages. We have also heard about ‘our old people’, ‘our youth’, ‘our essential workers’ and even ‘our dead’. Behind this tone, however, there could be an intention to hide errors, or to falsely convey carefulness. Honest rulers do not usually need nice words.

They just want them to be accurate.We have seen as well some tributes to the victims during hypertension medications, some of which we can doubt whether they serve to victims’ relief or to authorities’ promotion. We want rulers to be less aware of their own image and to stress truthfulness as a goal, even if this is a hard requirement not only for them, but for every single person. Language is essential in this issue, we think, since it is prone to be twisted and to become untrue. The old asthmatic man illustrates it with his ‘There’ll be speeches’ and his ‘Our dead…’, but this is not the only time in the novel in which Camus brings out the topic.

For instance, he does so when he equates silence (nothing can be thought as further from wordiness) with truth:It is at the moment of misfortune that one becomes accustomed to truth, that is to say to silence. (Camus 2002, Part II)or when he makes a solid statement against false words:…I understood that all the misfortunes of mankind came from not stating things in clear terms. (Camus 2002, Part IV)The old asthmatic, in fact, while praising the deceased Tarrou, remarks that he used to admire him because ‘he didn’t talk just for the sake of it.’ (Camus 2002, Part V).Related to this topic, what the old asthmatic says about political authorities may be transposed in our case to other public figures, such as scholars and researchers, media leaders, businessmen and women, health professionals… and, if we extend the scope, to every single citizen. Because hypocrisy, language manipulation and the fact of putting individual interests ahead of collective welfare fit badly with collective issues such as epidemics.

Hopefully, also examples to the contrary have been observed during hypertension medications.The story ends with the fireworks in Oran and the depiction of Dr Rieux’s last feelings. While he is satisfied because of his medical performance and his activity as a witness of the plague, he is concerned about future disasters to come. When hypertension medications will have passed, it will be time for us as well to review our life during these months. For now, we are just looking forward to achieving our particular ‘part V’.AbstractThis study addresses the existing gap in literature that ethnographically examines the experiences of Spanish-speaking patients with limited English proficiency in clinical spaces.

All of the participants in this study presented to the emergency department (ED) for evaluation of non-urgent health conditions. Patient shadowing was employed to explore the challenges that this population face in unique clinical settings like the ED. This relatively new methodology facilitates obtaining nuanced understandings of clinical contexts under study in ways that quantitative approaches and survey research do not. Drawing from the field of medical anthropology and approach of narrative medicine, the collected data are presented through the use of clinical ethnographic vignettes and thick description.

The conceptual framework of health-related deservingness guided the analysis undertaken in this study. Structural stigma was used as a complementary framework in analysing the emergent themes in the data collected. The results and analysis from this study were used to develop an argument for the consideration of language as a distinct social determinant of health.emergency medicinemedical anthropologymedical humanitiesData availability statementData sharing not applicable as no datasets were generated and/or analysed for this study..

Does lasix cause hypokalemia

Start Preamble does lasix cause hypokalemia http://hannahshands.org/what-do-you-need-to-buy-viagra/ Start Printed Page 58150 Food and Drug Administration, HHS. Proposed rule. The Food and Drug Administration (FDA, does lasix cause hypokalemia we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements.

Amend existing rules for consistency with a new OTC category does lasix cause hypokalemia. Repeal the conditions for sale applicable to hearing aids. Amend the existing labeling requirements for hearing aids. And update does lasix cause hypokalemia regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements.

This action, if finalized, would more clearly define prescription hearing aids. However, it would does lasix cause hypokalemia not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health. Submit either electronic or written comments on the proposed rule by does lasix cause hypokalemia January 18, 2022.

Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021. You may submit comments as follows. Please note that late, does lasix cause hypokalemia untimely filed comments will not be considered. Electronic comments must be submitted on or before January 18, 2022.

The https://www.regulations.gov electronic filing system does lasix cause hypokalemia will accept comments until 11:59 p.m. Eastern Time at the end of January 18, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic does lasix cause hypokalemia Submissions Submit electronic comments in the following way.

• Federal eRulemaking Portal. Https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.

Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows.

• Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions.

All submissions received must include the Docket No. FDA-2021-N-0555 for “Establishing Over-the-Counter Hearing Aids.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.

You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff.

If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket.

For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) at https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.

The title of this proposed collection is “Medical Device Labeling Regulations.” Start Further Info Srinivas Nandkumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, 301-796-5620, Srinivas.Nandkumar@fda.hhs.gov. With regard to the information collection. Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov. End Further Info End Preamble Start Supplemental Information Table of Contents Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Legal Authority Costs and Benefits Table of Abbreviations and Acronyms Commonly Used in This Document I.

Background A. Need for the Regulation B. Current Regulatory Framework for Hearing Aids C. History of This Rulemaking D.

Incorporation by Reference II. Legal Authority III. Description of the Proposed Rule A. Scope (Proposed § 800.30(a)) B.

Definitions (Proposed §§ 800.30(b) and 801.422(b)) C. Labeling (Proposed § 800.30(c)) D. Output Limits (Proposed § 800.30(d)) E. Other Requirements (Proposed § 800.30(e) and (f)) F.

Condition for Sale (Proposed § 800.30(g)) G. Preemption Provisions (Proposed § 800.30(h)) H. Proposed Repeal of Conditions for Sale and Modifications for Prescription Labeling (§§ 801.420, 801.421, 801.422) I. Proposed Amendments to Previous Exemption Decisions (Part 808) J.

Other Proposed Amendments IV. Findings Regarding Premarket Notification V. Proposed Effective and Compliance Dates A. Effective Date B.

Compliance Date for Hearing Aids Not Legally Offered for Sale Prior to the Effective Date C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to the Effective Date VI. Preliminary Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII.

Paperwork Reduction Act of 1995 IX. Federalism X. Consultation and Coordination With Indian Tribal Governments XI. References Executive Summary Purpose of the Proposed Rule Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life.

Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is proposing rules to address some of these concerns. Moreover, the FDA Reauthorization Act of 2017 (FDARA) directs FDA to establish a category of OTC hearing aids through rulemaking, and FDARA sets forth various requirements for OTC hearing aids, including preemption provisions.

In addition to protecting and promoting the public health, we have developed these proposed rules to establish the OTC category and implement the requirements of FDARA. Summary of the Major Provisions of the Proposed Rule FDA is proposing to establish a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids will be intended to address perceived mild to moderate hearing loss in people age 18 or older. Alongside the OTC category, we are proposing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the eventual OTC category.

We believe the proposals set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology. Among other things, FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls. We are proposing general controls for OTC hearing aids consistent with FDARA. Moreover, because the FD&C Act specifies that OTC hearing aids are those that use the same fundamental scientific technology as air-conduction hearing aids, we would realign the existing classification regulations for hearing aids by sound conduction technology.

However, the realignment would not affect the device class or premarket notification exemption status of any existing device. On the effective date of the final rule, we would realign current product codes to correspond with the revised regulations for consistency but would not otherwise change the codes. This rulemaking also affects other existing regulations that apply to hearing aids. FDA has established device restrictions for hearing aids that include labeling requirements as well as conditions for sale.

We are proposing to remove these device restrictions for hearing aids, and establish a new regulation for prescription hearing aid labeling. Further, FDA has by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are proposing to remove the regulations codifying these decisions and establish other regulations clarifying some of the effects of statutory preemption under FDARA.

Legal Authority The FD&C Act establishes a comprehensive system for the regulation of devices intended for human use. Hearing aids are devices intended for human use and so are subject to, among other requirements, the device provisions of the FD&C Act. FDA has authority to establish regulatory controls needed to provide reasonable assurance of safety and effectiveness for these devices. As such, FDA is establishing regulatory controls for OTC hearing aids and amending regulatory controls for prescription hearing aids.

Specific to OTC hearing aids, the FD&C Act and FDARA authorize multiple controls, including authority for FDA to establish requirements for device labeling, output limits, conditions for sale and distribution, and other requirements that provide reasonable assurance of safety and effectiveness of OTC hearing aids. FDARA specifically directs FDA to establish a category of OTC hearing aids by regulation that must include the aforementioned requirements. More generally, the FD&C Act further provides for labeling requirements as general controls such that devices (and other medical products) will not be misbranded. The FD&C Act also authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.

We are proposing the following regulations pursuant to these authorities and to fulfill the directive under FDARA. Additionally, both the FD&C Act and FDARA include preemption provisions applicable to hearing aids. Costs and Benefits This proposed rule to establish OTC hearing aids and align other regulations, if finalized, would generate potential cost savings for consumers with perceived mild to moderate hearing loss who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online. The proposed rule, if finalized, Start Printed Page 58152 would also generate costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule.

We estimate benefits of between $6 million and $147 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $63 million per year. We estimate annualized costs of between $1 million and $2 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $1 million per year. Combining benefits and costs, we used Monte Carlo analysis to estimate annualized net benefits of between $5 million and $145 million per year based on the 5th and 95th Monte Carlo percentile results with a mean of $62 million per year at both 3 percent and 7 percent discount rates. Table of Abbreviations and Acronyms Commonly Used in This DocumentAbbreviation/acronymWhat it means510(k)A premarket notification for certain devices.ANSIAmerican National Standards Institute.ASAAcoustical Society of America.CFRCode of Federal Regulations.CTAConsumer Technology Association.dBDecibel.dBAA-weighted decibel.EAEnvironmental assessment.FDAFood and Drug Administration.FD&C ActFederal Food, Drug, and Cosmetic Act.FDARAFDA Reauthorization Act of 2017.FONSIFinding of no significant impact.FRFederal Register.GMPsGood manufacturing practices.HzHertz.ISOInternational Organization for Standardization.MSWMunicipal solid waste.NASEMNational Academies of Sciences, Engineering, and Medicine.NIOSHNational Institute for Occupational Safety and Health.OMBOffice of Management and Budget.OSPL90Output sound pressure level with 90-dB input.OTCOver-the-counter.PCASTPresident's Council of Advisors on Science and Technology.PRIAPreliminary Regulatory Impact Analysis.PSAPPersonal sound amplification product.Pub.

LPublic Law.QSQuality System.SPLSound pressure level.U.S.CUnited States Code. I. Background FDA is proposing to define and establish general controls for an OTC category of hearing aids. We intend these proposals to provide for reasonable assurance of safety and effectiveness for these devices and improve access to and foster innovation in hearing aid technology for Americans, thereby promoting and protecting the public health.

We would make various other revisions, as described in this document, to align existing regulations with statutory requirements and the new OTC category. A. Need for the Regulation Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life (Refs. 1 and 2).

Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention (Ref. 3). The use of hearing aids has been linked to, among other health benefits, reductions in the incidence or severity of cognitive decline, depression, and other health problems in older adults (Ref. 3a and 3b).

Additionally, benefits of hearing aid use can include improved social participation and a better quality of life. Besides health benefits for individuals, more-widespread adoption of hearing aids could have broader effects. By increasing social participation, hearing aids could help to improve inclusion of individuals in family, economic, civic, and religious life. Thus, reducing barriers to hearing aid access might contribute to such improvements.

This could be particularly true for people of color, rural Americans, low-income individuals, and others for whom barriers to hearing aid access may be especially burdensome. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price) (Ref. 4). In addition, stakeholders have cited Federal regulations that require specific labeling and conditions for sale, initially implemented in the late 1970s, as barriers to access ( e.g., Refs.

5 to 7). This document proposes a number of changes to the regulatory framework for hearing aids to remove or reduce barriers to certain air-conduction hearing aids for perceived mild to moderate hearing impairment—a type of impairment often associated with aging—that have the potential to be of great benefit to the public health. These proposals follow the enactment of FDARA, which included provisions directing FDA to establish regulatory requirements for a new category of OTC hearing aids and amended the FD&C Act to add section 520(q) (21 U.S.C. 360j(q).

See Pub. L. 115-52). Section 520(q)(1) of the FD&C Act defines OTC hearing aids, in part, as devices available over-the-counter, without the supervision, Start Printed Page 58153 prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

Section 520(q)(2) of the FD&C Act requires that such devices be subject to the regulations FDA issues for them in accordance with section 709(b) of FDARA. Section 709(b) of FDARA requires that FDA establish a category of OTC hearing aids that includes, among other elements, requirements to provide reasonable assurances of the safety and effectiveness of these devices. We also make multiple proposals to prevent the sale of OTC hearing aids to or for people younger than age 18. This document does not, however, propose to create or classify a new device type.[] Further, this document does not propose to exempt additional devices from the premarket notification requirements under section 510(k) of the FD&C Act, commonly referred to as “a 510(k)” (21 U.S.C.

360(k)). Section IV of this document discusses our findings regarding premarket notification in more detail. We are simultaneously proposing related changes to the regulatory framework that currently applies to all hearing aids, as they are defined in § 801.420 (21 CFR 801.420), in light of the new OTC category and to ensure consistency across rules pertaining to hearing aids (see § 801.420(a)(1)). Detailed information about each proposal appears in section III.

B. Current Regulatory Framework for Hearing Aids Hearing aids, as defined in § 801.420(a)(1), are currently restricted class I and class II devices of multiple types. A summary of the current regulatory framework for these devices appears in table 1. Table 1—Summary of Current Regulatory FrameworkClassification regulation, 21 CFR section874.3300874.3305874.3315874.3325874.3950Device RestrictionsRestrictedRestrictedRestrictedRestrictedRestricted.Class I, 510(k) exempt 1Air-conduction (“legacy”)Class II, 510(k) exempt 1Wireless air-conductionClass IIBone-conductionTympanic membrane contact hearing aidSelf-fitting air-conductionTranscutaneous air-conduction hearing aid system.Product codesESD, LXB, MAH, LRB, LDGOSMPLKQDDNIX.1  510(k) exemptions are subject to the limitations in 21 CFR 874.9.

1. Hearing Aid Classifications Hearing aids are class I and class II wearable sound-amplifying devices intended to compensate for impaired hearing. They currently fall under five classification regulations (the following references are to sections in Title 21 of the CFR). a.

Hearing aid (§ 874.3300 (21 CFR 874.3300)). This device type includes air-conduction (class I, 510(k) exempt, subject to the limitations of exemption in § 874.9) and bone-conduction (class II) hearing aids. Class II bone-conduction hearing aids require a 510(k) notification. These are all restricted devices.

b. Wireless air-conduction hearing aid (§ 874.3305 (21 CFR 874.3305)). This device type is a hearing aid that incorporates wireless technology in its programming or use, for example, controls over Bluetooth. These devices are class II restricted, subject to the special controls that have been issued for these devices, and 510(k) exempt, subject to the limitations of exemption in § 874.9.

c. Tympanic membrane contact hearing aid (§ 874.3315 (21 CFR 874.3315)). This device type is a prescription device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. d. Self-fitting air-conduction hearing aids (§ 874.3325 (21 CFR 874.3325)). This device type is a hearing aid that incorporates technology, including software, that allows users to program their hearing aids.

This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fittings and settings. These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. e. Transcutaneous air conduction hearing aid system (§ 874.3950 (21 CFR 874.3950)).

This device type consists of an air-conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. Devices of these types may be either prescription (for example, devices for insertion deep in the ear canal) or non-prescription devices (which include the majority of air-conduction hearing aids).[] For the purposes of this rulemaking, we refer to non-wireless, non-self-fitting, air-conduction hearing aids as “legacy hearing aids,” which means all air-conduction hearing aids currently within § 874.3300 but not air-conduction hearing aids currently within §§ 874.3305, 874.3325, or 874.3950. Start Printed Page 58154 2.

Hearing Aid Restrictions Hearing aids are currently subject to a set of restrictions on sale, distribution, and use, established in accordance with section 520(e) of the FD&C Act. We will refer to those as “Hearing Aid Restrictions,” and they include requirements for professional and patient labeling, as a well as conditions for sale (see §§ 801.420 and 801.421 (21 CFR 801.420 and 801.421, respectively)). All legacy hearing aids, wireless air-conduction hearing aids, and self-fitting hearing aids (as well as other device types) fall within a separate, broader definition of hearing aids in § 801.420(a)(1), and therefore are currently subject to these restrictions. Among other requirements, § 801.420 specifies that the User Instructional Brochure labeling for hearing aids contain a warning statement for hearing aid dispensers that prompts them to advise prospective purchasers to consult with a physician if any of the listed medical conditions are present (see § 801.420(c)(2)).

We will refer to these medical conditions as “red flag” conditions in this proposal. The rule further prescribes a notice to prospective users and an additional statement about hearing loss in children (see § 801.420(c)(3)). It also requires the disclosure of technical data useful in selecting, fitting, and checking the performance of hearing aids (see § 801.420(c)(4)). Currently, § 801.421 specifies a number of conditions for sale for hearing aids.

Such conditions include that a prospective user must present to the dispenser a signed statement of medical evaluation from a physician prior to sale (see § 801.421(a)(1)). However, a prospective user who is 18 years of age or older may waive the medical evaluation requirement by signing a statement with a prescribed advisement (see § 801.421(a)(2)). A dispenser must provide an opportunity for the prospective user to review the User Instructional Brochure prior to signing a waiver and the sale of a hearing aid (see § 801.421(b)). Manufacturers and distributors must provide sufficient copies of User Instructional Brochures to dispensers, and upon written request, to prospective users.

Dispensers must similarly provide the brochures (or the name and address of a manufacturer or distributor to obtain a brochure) to prospective users upon request (see § 801.421(c)). Dispensers generally must retain a copy of a medical evaluation statement or signed waiver for 3 years (see § 801.421(d)). However, we announced in a guidance entitled “Conditions for Sale for Air-Conduction Hearing Aids” that we do not intend to enforce the medical evaluation, waiver, or recordkeeping requirements of § 801.421 with respect to prospective purchasers who are 18 or older (Ref. 8).

In addition to other applicable misbranding and adulteration provisions in sections 501 and 502 of the FD&C Act (21 U.S.C. 351 and 21 U.S.C. 352, respectively), hearing aids are currently subject to misbranding provisions for restricted devices under section 502(q) and (r) of the FD&C Act. Section 704(a) of the FD&C Act (21 U.S.C.

374(a)) authorizes FDA to inspect, among other things, certain records relating to restricted devices. 3. State Requirements for Hearing Aids Under certain circumstances, State requirements apply to hearing aids notwithstanding Federal requirements. In general, FDA's regulation of hearing aids preempts State law, meaning that a State or a political subdivision ( e.g., a city) may not establish or continue in effect its own requirement if that requirement is “different from, or in addition to,” a requirement under the FD&C Act (see section 521(a) (21 U.S.C.

360k(a))). Many States have established requirements equivalent to § 801.420 or § 801.421 ( i.e., not “different from, or in addition to” those regulations), which are not preempted by these Federal requirements. However, for other State requirements, FDA has granted and denied exemptions from preemption under section 521(b) of the FD&C Act for some States that have applied. FDA responds to applications for such exemptions by regulation, codified in subpart C of part 808 (21 CFR part 808).

Most of these regulations relate to hearing aids, and in some of these regulations, FDA has granted exemptions—meaning those States' requirements apply instead of, or in addition to, FDA's requirements—for. Specifying the physician expertise needed to examine prospective purchasers who are younger than 18 years of age. Advising purchasers when to seek medical attention based on “red flag” conditions. Providing purchasers with certain information and disclosures on receipts and other documentation.

Recordkeeping requirements in addition to the Hearing Aid Restrictions. And Providing written notice of a money-back guarantee where a State court held the State requirement was preempted. And FDA has denied exemptions—meaning the States could not establish or continue in effect requirements—for. Removing the waiver option for prospective purchasers who are 18 years of age or older.

Lowering the age at which a waiver of medical examination prior to purchase was available. Changing the expertise for examinations, when conducted, for people 18 years of age and older. Prohibiting certain marketing claims about improving hearing. And Adopting different device testing standards.

FDARA added a separate Federal preemption provision for State and local laws, regulations, orders, or other requirements (for brevity, we will refer to “State or local requirements” in this rulemaking) specifically related to hearing products (FDARA section 709(b)(4)).[] That provision may affect the applicability of State or local requirements for OTC hearing aids. Section III.G discusses the OTC hearing aid preemption provisions and the effects of this rulemaking. 4. Hearing Products Not Regulated as Hearing Aids FDA does not consider personal sound amplification products (PSAPs) to be “devices” within the meaning of section 201(h) of the FD&C Act (21 U.S.C.

321(h)) when they are not intended to aid a person with, or compensate for, impaired hearing and do not otherwise meet the device definition. Such PSAPs are not subject to medical device regulations, nor would the proposed requirements of this rulemaking apply to such PSAPs.[] Note that the name of a product on its own would not ordinarily demonstrate intended use. Thus, merely calling a product something besides “hearing aid” would not remove a product from device regulation under the FD&C Act if, for example, its labeling demonstrated that the product was intended to compensate for hearing loss. C.

History of This Rulemaking Although this proposal is the first step in this rulemaking, FDA has taken other steps to initiate an update of the regulatory framework for hearing aids. Start Printed Page 58155 Prior to the enactment of FDARA, FDA had considered means to improve access to hearing aids. For example, we considered a report on the public health implications of hearing loss in adults that made recommendations to improve affordability and accessibility of hearing aids and to foster innovative hearing aid technology. The October 2015 report by the President's Council of Advisors on Science and Technology (PCAST) recommended, among other actions, that, “FDA should approve [a] class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser” (Ref.

7). In addition, the report concluded, among other things, that the Federal requirement for a medical examination, or a written waiver of such examination, “provides little patient benefit, while acting as a barrier to access for the millions of Americans needing hearing assistance” (Ref. 7). Similarly, FDA, other Federal Agencies, and a consumer advocacy group co-sponsored a study entitled “Hearing Health Care for Adults.

Priorities for Improving Access and Affordability” through the National Academies of Sciences, Engineering, and Medicine (NASEM). The resulting NASEM report, published on June 2, 2016, similarly recommends that FDA create a new category of OTC “wearable hearing devices” (using a term distinct from “hearing aids”) and also that FDA remove the medical evaluation requirement for adults for hearing aids (Ref. 6). After a review of the literature and relevant clinical databases from the U.S.

Department of Defense and the U.S. Department of Veterans Affairs, NASEM concluded that the health risk of missed diagnosis of treatable causes of hearing loss in adults is low, and “[the] regulation [requiring a medical examination or waiver] provides no clinically meaningful benefit, and the waiver presents a barrier to access with no substantial enhancement of patient safety.” Both PCAST and NASEM provided recommendations regarding FDA Quality System requirements (which set forth requirements for good manufacturing practices or GMPs) for the proposed category of OTC hearing aids. PCAST stated the following. FDA should exempt this class of hearing aids from QSR regulation in its present form and substitute compliance with standards for product quality and recordkeeping appropriate for the consumer-electronics industry, developed by an appropriate third-party organization and approved by FDA.

Similar actions should be taken with respect to diagnostic hearing tests used to dispense and fit Class I hearing aids. However, NASEM recommended that these devices “[b]e subject to quality system regulation (QSR) requirements, but be considered for exemption from certain QSR requirements as determined by FDA to be appropriate for this category.” We held a public workshop on April 21, 2016, entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids,” (announced at 81 FR 784. See Ref. 9 for materials).

FDA requested comments on several topics relating to hearing healthcare technology and improved access, including the appropriate level of GMP regulation (Quality System requirements) to ensure the safety and effectiveness of air-conduction hearing aid devices in consideration of the PCAST report recommendations. FDA received hundreds of comments to the docket for this workshop prior to the (extended) deadline of June 30, 2016. In addition, 2 keynote speakers (from PCAST and NASEM), 12 invited speakers, and 24 public speakers offered comments or presentations at the workshop. Workshop speakers and submitters of docket comments were generally.

Healthcare professionals (or healthcare professional organizations), members of industry, patients or consumers, academics, consensus standards developers, and science organizations. Comments from this workshop ranged generally from strong opposition to strong support for the PCAST recommendations. Other comments were more nuanced. To summarize very broadly, all parties agreed that some combination of regulatory requirements and flexibility in compliance would provide reasonable assurance of safety and effectiveness.

The differences in opinion lie in the preferred approach and its implementation to achieve these common goals. For example, some preferred amending the QS regulation and relying on inspections while others preferred allowing voluntary conformity to a consensus standard potentially relying on third-party certification. In another effort to address the current regulatory framework, FDA also issued a guidance document, as noted above, related to the conditions for sale for air-conduction hearing aids. In that document, we announced our intent to reexamine and modify § 801.421 based on the PCAST and NASEM recommendations, as well as from other stakeholders, taking into consideration and addressing their recommendations as appropriate before adopting regulations for OTC hearing aids.

The docket no. FDA-2016-D-3466 included commentary that expressed support for the creation of a “basic” category of hearing aids such as OTC hearing aids and provided recommendations for measures to support safe and effective use. We also received multiple telephone calls expressing similar interest in reducing regulatory burdens and questioning how the issuance of the guidance affected States' requirements. In developing this proposed rule, we considered the input and questions we have received on the guidance, as well as the comments from the April 2016 public workshop and the recommendations from PCAST and NASEM.

D. Incorporation by Reference FDA is proposing to incorporate by reference the Method and tables for clause 4.1 of ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” dated January 2017, from the American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036. Https://www.ansi.org, 202-293-8020. You may download the standard from the web at https://webstore.ansi.org/​standards/​ansi/​cta20512017ansi.

The Method and tables for clause 4.1 describe how to measure frequency response and include technical data for adaptations for different circumstances. The Method and tables would provide a standardized way to quantify frequency response for OTC hearing aids and meet the related proposed requirements (see section III.E.1). FDA is also proposing to incorporate by reference ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” dated November 2014, from the American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036. Https://www.ansi.org, 202-293-8020.

ANSI/ASA S3.22-2014 describes tolerances and test methods used for certain measurements of hearing aid performance. The application of ANSI/ASA S3.22-2014 provides professional hearing aid fitters with standardized technical information to help them select the correct hearing aid and ensure optimal fit and performance for hearing aid users (see section III.H.2). II. Legal Authority The FD&C Act establishes a comprehensive system for the regulation of devices, as defined in section 201(h) of the FD&C Act, intended for human use.

Section 513 of the FD&C Act (21 U.S.C. 360c) defines three classes of devices, reflecting the regulatory Start Printed Page 58156 controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval) (see 21 U.S.C. 360c).

Hearing aids are devices intended for human use and are subject to the FD&C Act. Currently, air-conduction hearing aids are generally either class I or class II devices. FDARA amended the FD&C Act to apply requirements specific to certain hearing aids and defined the term “over-the-counter hearing aid” (see 21 U.S.C. 360j(q)).

We are issuing these requirements for OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes FDA to establish requirements for labeling, output limits, conditions for sale and distribution of OTC hearing aids, and other requirements that provide for reasonable assurance of safety and effectiveness of these devices. In addition, the FD&C Act provides that a device is misbranded unless, among other requirements, its labeling bears adequate directions for use (see section 502(f)(1) of the FD&C Act). Consistent with section 502 of the FD&C Act, FDA has issued regulations that exempt certain kinds of devices from the requirement for adequate directions for use. Section 502(f)(2) further requires adequate warnings against use of a device in those pathological conditions, or by children, where use of the device may be dangerous to health.

The labeling must also bear adequate warnings against unsafe dosage or methods or duration of administration or application (see section 502(f)(2) of the FD&C Act). Such warnings must be in such manner and form as are necessary for the protection of the users (see section 502(f)(2) of the FD&C Act). A device is also misbranded if its labeling is false or misleading in any particular (see section 502(a) of the FD&C Act). Section 201(n) of the FD&C Act states that in determining whether labeling or advertising is misleading, there shall be taken into account not only representations made or suggested but also the extent to which labeling or advertising fails to reveal material facts.

Other misbranding provisions under the FD&C Act would apply as well, including section 502(c), which deems a device to be misbranded if any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Additionally, section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act (21 U.S.C. 371(a)). The proposals in this rulemaking would be for the efficient enforcement of the FD&C Act because, if finalized, they will provide standards for the legal marketing of safe and effective hearing aid devices.

Violations of any final rules from this rulemaking, once in effect, would render the hearing aids adulterated and/or misbranded under sections 501 and/or 502 of the FD&C Act, and subject to enforcement action, for example, seizure (see section 304 of the FD&C Act (21 U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C. 332)), and criminal prosecution (see section 303 of the FD&C Act (21 U.S.C. 333)).

Prohibited acts include, among others, introducing an adulterated or misbranded device into interstate commerce (see section 301 of the FD&C Act (21 U.S.C. 331)). Under section 521 of the FD&C Act, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement that is different from, or in addition to, any requirement applicable under the FD&C Act to the device and that relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the FD&C Act (21 U.S.C. 360k).

Section 521 of the FD&C Act also provides that FDA may grant an exemption from preemption under certain circumstances. Section 709(b) of FDARA also includes a preemption provision with respect to requirements for OTC hearing aids. III. Description of the Proposed Rule We are proposing multiple related actions in this rulemaking.

Add to part 800, subpart B (21 CFR part 800, subpart B), definitions and other rules for OTC hearing aids. Remove § 801.420 and repeal § 801.421. Add to part 801, subpart H (21 CFR part 801, subpart H), § 801.422, labeling requirements for prescription hearing aids. Amend part 874, subpart D (21 CFR part 874, subpart D), in multiple places to update classification regulations for hearing aids and align hearing aid types by sound-conduction technology.

And Amend part 808, subparts A and C (21 CFR part 808, subparts A and C), by updating the Scope and removing most of the current regulations codifying previous decisions for exemption from Federal preemption for certain States. If this action is finalized, all non-OTC hearing aids will be prescription devices and would be subject to the labeling requirements in new § 801.422 as well as those in the existing § 801.109, but they would no longer be restricted devices. Note that a prescriber is any practitioner licensed by the law of the State in which the practitioner practices to use, or order the use of, the device. When the prescriber of a hearing aid need not be a physician, the labeling of a prescription hearing aid will describe other prescribers, for example, audiologists (see § 801.109(b)(1)).

We believe the proposed actions will, in combination, promote and protect the public health by, among other things, providing reasonable assurance of safety and effectiveness of OTC and prescription hearing aids. These actions would also help minimize the complexity of the applicable regulations, if finalized, through organization. We are proposing to add the OTC Hearing Aid Controls to 21 CFR part 800, subpart B, entitled “Requirements for Specific Medical Devices,” which would make them easy to locate. Labeling requirements for prescription devices would remain in part 801, Labeling, subpart H, “Special Requirements for Specific Devices.” Table 2 outlines the proposed hearing aid rules.

Section III.I summarizes the proposed revisions to part 808. Table 2—Outline of Proposed Hearing Aid Rule800.30801.422874.3301874.3305Over-the-counter hearing aid controls 1Prescription hearing aid labeling 1Bone-conduction hearing aidAir-conduction hearing aid(a) Scope.(a) Scope.(a) Identification.(a) Identification.(b) Definitions.(b) Definitions.(b) Classification.(b) Classification.Start Printed Page 58157(c) Labeling.(c) Labeling.Product codes LXB, MAH. • Legacy. • Package. • Package. • Wireless. • Labeling Inside the Package. • Labeling Inside the Package. • Self-Fitting. • Labeling on the Device. • Labeling on the Device.Product codes ESD, OSM, QDD, • Technical Specifications. • Technical Specifications. LRB, and LDG.  • Misbranding.(d) Output Limits.(d) Incorporation by Reference.(e) Electroacoustic Performance. • Distortion Control. • Self-generated Noise. • Latency. • Bandwidth. • Smoothness.(f) Design Requirements. • Insertion Depth. • Atraumatic Materials. • Proper Fit. • Tools, Tests, or Software.(g) Condition for Sale.(h) Effect on State Law.(i) Incorporation by Reference.1  These requirements would apply in addition to all other applicable requirements, including applicable labeling requirements in parts 801 and 830 (21 CFR parts 801 and 830). For example, for prescription devices, the labeling requirements in § 801.109 would continue to apply in addition to new § 801.422. A.

Scope (Proposed § 800.30(a)) The regulation would clarify which devices are subject to the OTC Hearing Aid Controls. Among other changes, FDARA amended the FD&C Act to define the term “over-the-counter hearing aid,” and section 709 of FDARA directs FDA to establish certain requirements for labeling, output limits, conditions for sale, and other requirements that provide reasonable assurances of the safety and effectiveness of OTC hearing aids. We propose to call this set of requirements “Over-the-Counter Hearing Aid Controls” and add § 800.30 to establish the OTC category of hearing aids and their requirements. The scope, proposed paragraph (a), would specify the devices to which the regulation would apply, assisting with the determination of applicable requirements.

This provision clarifies that a hearing aid is either in the prescription or OTC category and that, regardless of category, special controls found in the applicable classification regulation and other requirements in the FD&C Act apply. B. Definitions (Proposed §§ 800.30(b) and 801.422(b)) FDA proposes to include the definition of an OTC hearing aid, consistent with the definition in section 520(q)(1) of the FD&C Act, and the definitions of other terms integral to understanding § 800.30. In several cases, we are proposing parallel definitions (sometimes slightly modified) under the proposed requirements for prescription hearing aid labeling in § 801.422.

Defining hearing aids. FDARA authorizes controls for devices that, among other characteristics, use the same fundamental scientific technology as air-conduction hearing aids under §§ 874.3300 or 874.3305. Section 520(q)(1)(A)(i) of the FD&C Act does not specifically refer to § 874.3325 because, at the time of FDARA's enactment, FDA had not classified that device type. However, we consider self-fitting hearing aids currently classified under § 874.3325 to be eligible for regulation as OTC hearing aids.

We consider them as such because, although self-fitting hearing aids under § 874.3325 differ from hearing aids under §§ 874.3300 and 874.3305 in that they incorporate technology, including software, that allows users to program their hearing aids, self-fitting hearing aids use the same air-conduction technology as hearing aids under §§ 874.3300 and 874.3305. Self-fitting hearing aids also meet the other elements of the OTC hearing aid definition in section 520(q)(1)(A) of the FD&C Act. For example, self-fitting hearing aids, through tools, tests, or software, allow the user to control the hearing aid and customize it to the user's hearing needs (see section 520(q)(1)(A)(iii) of the FD&C Act). The proposed definitions of “hearing aid” (which is the current definition), “air-conduction hearing aid,” “over-the-counter hearing aid,” and “prescription hearing aid” help to delineate the different device categories.[] As stated in section 520(q)(1)(B) of the FD&C Act, the definition of “over-the-counter hearing aid” does not include PSAPs.

Similarly, the definition of “hearing aid” more generally excludes PSAPs that are not intended to aid with or compensate for impaired hearing. The proposed definition of “prescription hearing aid” in proposed § 801.422 is the same as that in the OTC Hearing Aid Controls except that the definition for prescription devices would cross-reference the OTC Hearing Aid Controls, proposed § 800.30. Defining licensed persons. In that vein, OTC hearing aids will be available without the supervision, prescription, or other order, involvement, or intervention of a licensed person (section 520(q)(1)(A)(v) of the FD&C Act).

A definition of “licensed person” would help delineate that a patient or consumer of OTC hearing aids will not need to consult an audiologist, a physician, or other licensed person prior to or after purchasing an OTC Start Printed Page 58158 hearing aid. The proposed definition of “licensed person” also clarifies that FDA interprets “licensed person” to include businesses consistent with the broad definition of “person” in section 201(e) of the FD&C Act. For example, OTC hearing aids may be available for sale from businesses that are not specially licensed to distribute OTC hearing aids.[] FDA does not interpret section 520(q)(1)(A)(v) of the FD&C Act or section 709(b) of FDARA as preempting a State's ability to establish or continue in effect generally applicable State business or professional licensing requirements. In general, such requirements would not be “specifically related to hearing products,” so they are not subject to section 709(b)(4) of FDARA.

If a person purports to be a licensed professional or business, then a State could regulate the person as such. Thus, for example, a person identifying as an “audiologist” would be subject to State professional or facility licensure requirements because an audiologist is a licensed professional. However, unlike identifying as an “audiologist,” some descriptions for professions do not on their own imply licensure in relation to OTC hearing aids. Section 709(b)(4) of FDARA lists certain activities that may be undertaken with respect to OTC hearing aids without the supervision, prescription, or other order, involvement or intervention of a licensed person.

FDARA specifically lists the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids. (For convenience, we will refer to these activities collectively as “commercial activity” in this document.) Thus, a person representing as a marketer, seller, dispenser, distributor, or customer support representative (or an equivalent description) of OTC hearing aids would not be a “licensed person” for the purposes of § 800.30 solely for that reason. Nor could a State require such persons to undertake special licensing or equivalent activities. In contrast, a person voluntarily identifying, for example, as a “licensed dispenser” ( i.e., not just a “dispenser”) would be subject to corresponding State requirements for such dispensers to the extent that the State requirements do not restrict or interfere with commercial activity involving OTC hearing aids (see section 709(b)(4) of FDARA).

The proposed definition of “licensed person” specifies the descriptions of profession, consistent with section 709(b)(4) of FDARA, that would not, on their own, imply licensure relating to OTC hearing aids. Section III.G of this document describes other preemption scenarios in addition to licensed persons. Defining tools, tests, or software. Another element of the definition of OTC hearing aids requires that users be able to control or customize the devices through tools, tests, or software (see section 520(q)(1)(A)(iii) of the FD&C Act).

We interpret this requirement to refer to the ability for a layperson to perform such activities. As such, the proposed definition of “tools, tests, or software” clarifies that OTC hearing aids are those devices that allow lay users to control the device and customize it, such as the device's output, to meet their individual hearing needs. Other definitions. The proposed definition of “used hearing aid” in both the OTC and prescription device provisions clarifies which hearing aids would be subject to certain proposed labeling requirements for used or rebuilt hearing aids.

The proposed definitions are the same for OTC and prescription hearing aids, and they are derived from the current definition in § 801.420 except that we have revised the wording for clarity. The proposal for prescription hearing aid labeling in § 801.422 retains the definition for “dispenser” that is currently applicable to all hearing aids. However, we propose to revise the wording to clarify that the definition applies only for purposes of prescription hearing aid labeling and propose other clarifying revisions to track the definition of “person” in section 201(e) of the FD&C Act more closely. We believe the definition will continue to be useful because the proposed requirements for prescription hearing aids refer to the dispenser.

FDA welcomes comments on the definitions pertinent to the regulation of OTC hearing aids (as well as any other portion of this proposal). In particular, we seek comments on the clarity of the definitions and ways to improve the definitions to encourage and support the broad availability of safe and effective devices. C. Labeling (Proposed § 800.30(c)) We are proposing labeling requirements to provide consumers with essential information for the safe and effective use of OTC hearing aids.

Section 709(b)(2)(C) of FDARA specifically directs FDA to include, among appropriate labeling requirements, a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed healthcare practitioner. In addition, section 709(b)(2)(A) of FDARA directs FDA to establish requirements that provide reasonable assurances of the safety and effectiveness of OTC hearing aids, and we intend the proposed labeling requirements to do so. In considering which statements to require, we note the important role of information in supporting broader use of OTC hearing aids. As part of the 2016 FDA hearing aid workshop, the Hearing Loss Association of America presentation stressed the importance of clear labeling to inform consumers so that the consumer “is empowered and knows what they're buying and knows the limitations and what's possible” (Refs.

9 and 10). FDA agrees, and we have proposed labeling requirements to empower consumers. Further the proposed conspicuous statement that OTC hearing aids are intended for people age 18 years and older is necessary because the use of OTC hearing aids in people younger than 18 presents risks to health beyond those typically associated with use in older people. Whereas hearing loss in older adults is most commonly related to noise exposure and aging, the etiology (causes) of hearing loss in younger people is varied and may result from conditions that warrant prompt diagnosis to avoid serious risks to health.

These conditions may not be readily apparent and can include, but are not limited to. Congenital malformations (present since birth) of the external, middle, or inner ear. s, for example, otitis media (an inflammation of the middle ear) or congenital s. Genetic causes, including hereditary syndromes that can involve cardiac, ophthalmic, renal, neurologic, and other organ systems (that is, syndromes that can involve the heart, eyes, kidneys, nerves, and other organs).

Or Certain exposures, for example, lead poisoning, hyperbilirubinemia (a buildup of a metabolic byproduct, bilirubin, in the blood), and drug ototoxicity (a toxic effect on the ear or its nerves). The use of a hearing aid to treat hearing loss related to these conditions, without a medical evaluation, may delay diagnosis and treatment of the Start Printed Page 58159 underlying condition. Further, prompt diagnosis is critical because, left untreated, these conditions may worsen, with potentially lifelong, adverse health effects. Because the use of OTC hearing aids in people younger than 18 presents risks to health beyond those typically associated with use in older people, the proposed conspicuous statements are appropriate and provide reasonable assurance of safety and effectiveness of OTC hearing aids.

The proposed labeling provisions include requirements for labeling on the package and inside the package, along with requirements for labeling on the device itself. These requirements would apply in addition to all other applicable labeling requirements in, for example, parts 801 and 830. In any of the labeling, manufacturers could continue to include additional truthful, non-misleading information provided it does not conflict with other requirements (such as those mentioned above). In proposing where to place labeling statements—on the package or inside the package—we have considered when users, prospective users, and others should become aware of information (before or after purchase).

We have also considered the limited space available on the packaging as well as simplicity of format. FDA welcomes your comments on the proposed labeling requirements, including the placement or conspicuousness of statements, as well as whether the statements are clear and understandable. For example, in reviewing the proposals, did you find important information quickly?. Did you find the information clear and easy to understand?.

We are particularly interested in your feedback about phrasing or formatting to convey information to people who are anticipated users, or more generally, who are not hearing health professionals. A rationale or evidence would make your feedback more useful. For example, if a proposed statement is unclear, telling us why is generally more helpful than saying only that you find the statement to be unclear. 1.

Package Labeling We are proposing that the outside of the package include information that consumers would need to know prior to purchasing the device, such as who is a candidate for the device, how to determine if you are a candidate, and when to seek professional help before trying the device. We believe this information empowers consumers and answers threshold questions about the suitability of purchasing an OTC hearing aid for their hearing needs. This proposal would also emphasize who the intended user is, to reduce the likelihood that people younger than 18 would purchase or use an OTC hearing aid. To summarize, the proposed statements on the package describe.

A conspicuous warning that the device is not for users younger than 18 years old. The symptoms of perceived mild-to-moderate hearing loss. Considerations for seeking a consultation with a hearing healthcare professional. And Red flag conditions.

Warnings to consumers regarding signs and symptoms that should prompt a consultation with a licensed physician (preferably an ear specialist). However, we are not proposing to require other information on the package, for example, mobile operating system compatibility or whether the package contains the necessary batteries. Further, we are proposing language that accurately conveys information to readers without relying on specialized knowledge ( i.e., for laypeople). We welcome your comments on whether to require other information on the package labeling and whether you had any difficulty understanding the information (and if so, your suggestions for improvements).

a. Symptoms suggesting perceived mild to moderate hearing loss. Prospective users may not know their definitive degree, configuration, or etiology of hearing loss. That is, they may not know the exact nature or cause, so commenters for the public meeting discussed various ways to communicate the signs of perceived mild to moderate hearing loss and reasons to seek medical evaluation.

They generally agreed that such information should appear on the outside of the package. We agree with this sentiment and are proposing that the information be readily apparent prior to purchase to help people to determine whether an OTC hearing aid may benefit them. To that end, we are proposing four scenarios that a person may recognize (symptoms) that suggest perceived mild to moderate hearing loss. We have selected these scenarios because they commonly present difficulties to people with perceived mild to moderate hearing loss and are situations in which users are likely to benefit from the use of OTC hearing aids.

We have also based the selection on stakeholder input from the public workshops. Although people with normal hearing may sometimes experience these scenarios, people with perceived mild to moderate hearing loss will experience them more frequently, if not regularly. We have phrased the information to emphasize that the device is intended for people who are 18 or older, and the phrasing avoids medical and technical terms while describing everyday situations. b.

Considerations for seeking consultation with a hearing healthcare professional. However, because a prospective user may have hearing impairment beyond, or different from, perceived mild to moderate hearing loss, we are proposing a statement to assist people in evaluating the potential for increased benefit from an OTC hearing aid. We believe this information is important, and have titled it as such, and appropriate for users and prospective users who are not familiar with hearing aids. c.

€œRed flag” conditions. In that vein, we are proposing to continue to require a statement advising users and prospective users to seek medical care if they exhibit any one of a number of conditions. We are not modifying the list of conditions from its present form except for phrasing and formatting changes to improve readability, as well as a change to the time periods (from 90 days to 6 months). We intend the change to the time periods to encourage consumers to consider a longer personal history, which may help them to identify the conditions without the involvement of a licensed person.

The list includes reliable indicators of the possibility of an underlying medical condition that a hearing aid cannot treat. For example, fluid, pus, or blood coming out of the ear may indicate an active , as could sudden, quickly worsening, or fluctuating hearing loss. An examination by a physician, preferably an ear specialist, would determine whether such an underlying condition is present and treatable, potentially halting or reversing hearing loss. d.

Other information. We are also proposing to require that the outside package include a web address and telephone number for consumers to access a digital copy or request a paper copy of all labeling, including the labeling inside the package, for that OTC hearing aid. A website could provide easy access to the more comprehensive information found in the labeling inside the package and could allow the use of other media to convey information. FDA is proposing to require that this labeling be available online or be able to be requested by phone prior to purchase to facilitate product familiarity to make a purchasing decision.

We believe having the information found inside the package will help prospective users Start Printed Page 58160 choose a safe and effective device without the involvement of a licensed person. As proposed, this information would be available without the need for consumers to register for access, for example, by registering for a website member login. Further, a download page could include, but would not be required to include, additional resources, for example, video explanations or tutorials to aid prospective users in selecting and using a device, as well as a mechanism for reporting complaints or adverse events. Since such additional resources would not be required under this proposal, accessing such resources could entail, for example, registering as a website member.

Please note that we are not proposing to require the distribution of paper copies for all OTC hearing aids because an analogous provision in the Hearing Aid Restrictions yielded little benefit—very few people requested a review of the paper copy—while adding to the regulatory burden. We are seeking comment on these proposed requirements (and any other portion of this proposed rule) regarding equitable access to the information and/or OTC hearing aids. We are also proposing to require that the manufacturer disclose its return policy or, if none, state that it does not accept returns. Such a requirement would be appropriate, because prospective users of OTC hearing aids may be unsure whether an OTC hearing aid will meet their hearing needs.

If an OTC hearing aid does not meet a user's hearing needs, the user may leave the device in the “dresser drawer.” (This is a common description of the phenomenon of relegating the device to disuse—putting it away, never to use it again—and foregoing the potential benefit of a more-satisfactory device). Thus, a statement of the return policy would be appropriate because, without the services of a licensed person, some users may be more dependent on the manufacturer's return policy (as opposed to the licensed person's) to avoid leaving an OTC hearing aid in the dresser drawer. A statement of the return policy would provide appropriate information to prospective users to help them determine the suitability of options given individual circumstances and preferences such as budget and willingness to try multiple OTC hearing aids. Additionally, consistent with the existing hearing aid requirement in § 801.420(c)(5), we are proposing that, when an OTC hearing aid is used or rebuilt, the outside package declare that fact.

These requirements would advance the public health by facilitating the purchase of devices that meet users' hearing needs. We are not proposing to require that manufacturers accept returns under these proposed Federal regulations. However, we likely would not consider a generally applicable State or local requirement to accept returns ( i.e., the requirement applies to any product) as a requirement specifically related to hearing products. Further, we believe that a State or local requirement for retailers (persons who sell to end users) to accept returned OTC hearing aids would likely promote—rather than restrict or interfere with—commercial activity involving the devices by reducing the financial risk to purchasers.

As such, generally, State or local requirements for returns would continue to apply provided they do not conflict with the final rule based on this rulemaking. We are seeking comment on whether such a State or local requirement would promote, rather than restrict or interfere with, commercial activities involving OTC hearing aids. Participants at the June 9, 2017, NASEM public workshop generally agreed with the importance and utility of requiring certain information on the package. Participants discussed potential labeling requirements such as these for OTC hearing aids (see Ref.

11). Numerous participants focused on the signs and symptoms of consumers who have mild-to-moderate hearing loss and might potentially benefit from OTC hearing aids. Specifically, participants expressed concerns that consumers would need information to help decide whether to purchase the products and/or whether to seek professional services. The proposed requirements in this document have taken these comments into account.

2. Labeling Inside the Package We are proposing to require that manufacturers place labeling inside of the package with the information that consumers will need after purchasing an OTC hearing aid for its safe and effective use. The proposed content of this labeling includes. Warnings, cautions, and notes, including a conspicuous statement warning against the use of the OTC hearing aid in people younger than 18 years old as well as a warning regarding “red flag” medical conditions to prompt consumers to consult with a licensed physician and a note about how to report adverse events to FDA.

Illustration(s) of and information about the controls, user adjustments, and the battery compartment. A description of any accessory that accompanies the OTC hearing aid. • Adequate directions for use, consistent with § 801.5 (21 CFR 801.5), including but not limited to information on sizing and inserting the eartip as well as the tools, tests, or software that allow the user to control and customize the OTC hearing aid to the user's hearing needs ( e.g., to self-select, self-fit, and self-check the performance of the device). Technical specifications to allow users, prospective users, and others to evaluate and compare the performance of OTC hearing aids.

Description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid. Identification of known physiological side effects associated with using the OTC hearing aid that may warrant consultation with a physician, including but not limited to skin irritation and accelerated build-up of ear wax (cerumen accumulation). Information on repair services. And If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies.

We believe these labeling requirements for OTC hearing aids will help provide reasonable assurance of safe and effective use of OTC hearing aids for consumers with perceived mild-to-moderate hearing loss. We intend the proposed labeling requirements to provide lay consumers with adequate information, in particular, to ensure that those purchasing OTC hearing aids know when to seek professional intervention, how to use the device safely and effectively, and where and how to obtain additional information or assistance. The 2016 NASEM report supports FDA's proposal in that it similarly recommends that OTC hearing aids “[i]nclude thorough consumer labeling, including information on. Frequency gain characteristics.

Adequate directions for use. Communication challenges for which it may be helpful to seek professional consultation. And medical situations, symptoms, or signs for which to consult with a physician” (Ref. 6).

We agree that thorough consumer labeling will assist users, potential users, and others with selecting, fitting, and wearing OTC hearing aids. Even so, the proposed requirements in this rulemaking are not intended as a substitute for other FDA regulations. Thus, for example, if adequate directions for use were to require additional information beyond that proposed in this rulemaking, manufacturers would need to include Start Printed Page 58161 that additional information (see § 801.5 regarding adequate directions for use). As for the NASEM report's recommendations for OTC hearing aids regarding information about communication challenges and medical indicators, we agree that such information will help provide reasonable assurance of safety and effectiveness, and we have included that information, as well as the full-on gain value in our proposed labeling requirements.

(Gain is a measure of amplification, and its full-on value is its maximum. We provide an explanation of gain in section III.D.2.) We are not proposing to require additional technical information in the labeling for OTC hearing aids other than those in proposed § 800.30(c)(4). However, the labeling may optionally include such information if desirable. For example, technical information similar to what is currently required for all hearing aids may be useful in assisting audiologists offering services to users (see § 801.420(c)(4)).

Multiple stakeholders voiced a similar view during the 2016 FDA workshop (Refs. 9, 10, and 12). Some added that scientific or technical information (in addition to the information we are proposing to require for OTC hearing aids) may be meaningful for consumers to make their decisions, especially if they are familiar with the technology. Although such additional information may be desirable for some consumers, FDA does not believe it is necessary to assist consumers in their selection.

FDA intends to issue at a later date a separate comprehensive guidance document that discusses, in part, labeling information and communicating that information with the goals of increasing transparency and choice to consumers. In accordance with 21 CFR 10.115, we will announce the availability of the draft of that guidance separately from this rulemaking, and the announcement will include information for submitting comments about that guidance, which will be separate and distinct from comments for this rulemaking. We do not intend to consider comments submitted to the docket for this rulemaking unless they pertain to the proposals in this document. 3.

Labeling on the Device Itself We are proposing to require that the labeling on the device itself include the serial number and symbol(s) for proper battery insertion orientation when applicable. If the device has been used or rebuilt, a tag indicating such would have to be physically attached to the device in addition to the statement on the outside of the package. D. Output Limits (Proposed § 800.30(d)) FDA is proposing a maximum acoustic output limit requirement for an OTC hearing aid to provide reasonable assurance of safety and effectiveness.

Section 709(b)(2)(B) of FDARA directs FDA to establish or adopt output limits appropriate for OTC hearing aids. A high output can be unsafe and further impair hearing. However, too low an output reduces device effectiveness and can lead to poor device performance, including clipping and distortion. In turn, poor performance would reduce consumer satisfaction and use of the devices.

We believe that the proposed output limits balance the above considerations for these devices, so the limits are therefore appropriate for OTC hearing aids. 1. Overview of Proposed Output Limits We propose a maximum OSPL90 output level of 115 dB sound pressure level (SPL) as a general rule to balance consumer safety with device performance.[] However, we would permit a limit of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control ( i.e., volume adjustment). This is because a user-adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device's limit.

Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device's limit, at any given moment. Relatedly, we are proposing that the device labeling state the value of the maximum OSPL90 level (see section III.C.1). We have proposed output limits to prevent injuries from exposure to loud sounds when amplified by OTC hearing aids while still allowing a sufficient dynamic range of outputs, called “headroom,” to provide effective amplification for users with perceived mild to moderate hearing loss.

A device without sufficient headroom (when the output limit is too low) would not be as effective as a device with a higher output. However, a device with too high an output limit could further worsen hearing impairment. 2. Data and Stakeholder Perspectives on the Proposed Output Limit We base the proposed limits on physiological data and stakeholder input, some of which appear in Clause 4.3 of ANSI/CTA-2051, a voluntary consensus standard (Ref.

13). Note that, although ANSI/CTA-2051 is a consensus standard for PSAPs, we believe that this standard is also relevant for OTC hearing aids, which provide personal sound amplification, albeit for purposes of aiding with or compensating for impaired hearing. The standard's basis for the output limit is a national workplace safety guideline, Occupational Noise Exposure, from the National Institute for Occupational Safety and Health (NIOSH) (Ref. 14).

NIOSH developed this standard, which we will refer to as NIOSH-98, to define permissible exposure time depending on the intensity of the sound. In general, the relationship between the loudness (SPL) and the time before damage to hearing is inversely related. The louder the sound, the shorter the time before hearing damage. Above about 85 dBA (A-weighted decibels), the exposure time is cut in half for every 3 dB increase in sound level (Ref.

14).[] Thus, the difference between recommended exposure times for 115 dB SPL and 120 dB SPL is approximately 61 seconds, where 115 dB SPL provides approximately triple the permissible exposure time than 120 dB SPL (see the next section for a more detailed explanation of the “3-dB exchange rate”). Appendix A of ANSI/CTA-2051 describes this tradeoff between output level and exposure time, providing a rationale for a maximum OSPL90 output limit of 120 dB based on NIOSH-98. For the purposes of that standard, NIOSH found that 115 dBA SPL is acceptable for up to about 30 seconds. ANSI/CTA-2051 explains that this allows the user sufficient time to turn off or remove the hearing aid before the exposure becomes Start Printed Page 58162 unacceptably dangerous to hearing ability.

ANSI/CTA-2051 observes that sound levels of desirable, “real-life sonic events” can approach the NIOSH-98 level, for example, a live symphony in which a user would want to experience “occasional peaks” undistorted. However, a lower output limit would not allow enough headroom for a faithful reproduction of such peaks and would lead to output clipping or distortion. Thus, a limit that allows desirable peaks, but sufficient time to react to undesirably loud sounds, would be ideal. As ANSI/CTA-2051 explains, 115 dBA is equivalent to an OSPL90 value of approximately 120 dB SPL with an allowance of 28 seconds to react.

FDA agrees that an OTC hearing aid should provide sufficient headroom to amplify relatively loud sounds such as those in a symphony, yet the device should not have an output so high that the user does not have time to act before sustaining injury. Further, the output should not be consistently at a limit of 120 dB SPL, accomplished through the inclusion of input-controlled compression and user-adjustable volume control. In addition to considering the ANSI/CTA and NIOSH standards supporting the proposed limits, we considered stakeholder input. On June 9, 2017, NASEM held a public workshop meeting where participants discussed, among other topics, a 120-dB SPL maximum output limit for an OTC hearing aid (see Ref.

11). Numerous speakers commented that an OSPL90 output limit somewhat lower than 120 dB SPL for OTC devices would likely still provide sufficient amplification and headroom for individuals with perceived mild to moderate hearing loss while providing a safety margin in terms of sound-intensity exposure. Additional comments during the NASEM workshop raised the importance of input-controlled compression and the inclusion of a user-adjustable volume control in order to help reduce overamplification. Each of those features can limit the device's output by dynamically reducing device gain as the input level increases, thus increasing the safety profile of a device.

The user generally would not be listening at louder output levels as often as would occur without these features. FDA has also reviewed numerous public comments on the risk of harm from excessive output, stemming from our 2016 public workshop, Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids (see Refs. 9, 15, and 16). We agree that excessive amplification from OTC hearing aids could pose a risk to individuals' health and thus are proposing that the maximum output (OSPL90) of OTC hearing aids not exceed a certain value, depending on device design features, that would provide users enough time to react to loud sounds to prevent injuries.

Some stakeholders have suggested inclusion of gain limits for OTC hearing aids. Gain is a measurement based on the ratio between the output and the input or, to simplify further, how much the device amplifies (or reduces) the input. A gain limit would further reduce the maximum device output because the device would sometimes reach the gain limit, providing no further amplification, before it reached the output limit. We are proposing not to limit the device gain because we believe that the proposed maximum output limit (together with the other proposed requirements) will provide reasonable assurance of safety and effectiveness without limiting the device gain also.

Moreover, a gain limit may unduly constrain the design of effective devices. Appropriate gain characteristics can depend on the implementation of the amplification circuit design ( e.g., linear amplification versus wide dynamic range compression). Thus, appropriate gain settings for one device may not be appropriate for another device of a different design. We believe that allowing flexibility in the gain settings will help maximize the effectiveness of the particular circuit design a manufacturer implements for a device to address perceived mild to moderate hearing loss.

In light of this, and since a maximum output limit would also in effect limit gain, we do not believe a separate, additional gain limit is necessary to provide reasonable assurance of safety and effectiveness. We also note that the NASEM report does not recommend any limit on gain for OTC devices, only on maximum output (Ref. 6). 3.

The Proposed Output Limit Requirements Help Provide Reasonable Assurance of Safety and Effectiveness In further consideration of user-adjustable volume controls and input-controlled compression, we believe that these two design features together will sufficiently mitigate the risk of a higher maximum output limit (from 115 dB SPL up to and including 120 dB SPL) by reducing the likelihood that the user will experience excessive sound levels for periods long enough to sustain damage to hearing (Ref. 14). Input-controlled compression such as wide dynamic range compression is also associated with hearing performance benefits in realistic environments that have varying levels of sound intensity for persons with mild-to-moderate sensorineural hearing loss (see, e.g., Refs. 17 to 21).

That is, besides reducing the device's effective output limit, input-controlled compression also generally helps users hear better in daily situations. In reaching this proposal on output limits, we note that hearing aids, including OTC hearing aids, are intended to be worn during all waking hours in a wide variety of listening environments and situations. Thus, user comfort is relevant to safety and effectiveness, and input-controlled compression and user-adjustable volume control increase comfort by dynamically adjusting gain and keeping outputs lower. This contributes to effectiveness and user satisfaction because users are generally more willing to wear a comfortable device consistently, maximizing the benefits of the device and the impact on public health.

We are not proposing to require input-controlled compression and a user-adjustable volume control for all OTC hearing aids, however. Thus, devices that do not have both of these features (which, in effect, reduce the device's output limit) would have to respect a 115 dB SPL limit, which would more than triple the safe exposure time compared to a 120 dB SPL limit (Ref. 14).[] Users would have ample time to take appropriate action to mitigate unacceptably high sound levels, for example, by adjusting the volume (if the device has a user-adjustable volume control), turning the device off, removing the device from the ear, or moving out of the loud environment. As noted above, the device labeling would also be required to include a reminder to consumers that, if they are in a loud listening environment that warrants hearing protection, they should remove their hearing aid(s) and use hearing protection.

To summarize, we believe that a 115 dB SPL output limit would help provide reasonable assurance of safety and effectiveness for the intended population. However, we acknowledge that 120 dB SPL could have additional effectiveness potential in certain circumstances, for example, when listening to a symphony by a live orchestra (Ref. 13). As discussed above, we believe that achieving that potential would be safe only if the device also Start Printed Page 58163 includes input-controlled compression and a user-adjustable volume control.

Overall, we believe this device-design contingent proposal for output limits helps provide reasonable assurance of safety and effectiveness of OTC hearing aids while providing ample design space for innovation. E. Other Requirements (Proposed § 800.30(e) and (f)) Although certain labeling and output limits are necessary for reasonable assurance of safety and effectiveness of OTC hearing aids, these requirements alone are not sufficient to do so. FDA is therefore proposing that the devices must meet certain performance and design requirements in order to help provide reasonable assurance of safety and effectiveness, pursuant to section 709(b)(2)(A) of FDARA.

1. Electroacoustic Performance Requirements To Help Provide a Reasonable Assurance of Safety and Effectiveness We are proposing to establish electroacoustic performance requirements to help ensure that the output of an OTC hearing aid safely and effectively compensates for perceived mild to moderate hearing loss in people age 18 and older. Electroacoustic performance describes how well a hearing aid converts an electrical signal, either digital or analog, into a sound (acoustic energy) or vice versa. Currently, hearing aid labeling must include technical data for certain performance characteristics gathered according to the test methods specified in ANSI/ASA S3.22-2003 (see § 801.420(c)(4)).

We do not believe, however, that the data that conform to ANSI/ASA S3.22 are adequate for consumers to select their own hearing aid without the supervision, involvement, or intervention of a licensed person (among other reservations). This is because ANSI/ASA S3.22 does not specify any minimum performance requirements. Instead, it specifies tolerances, which are acceptable ranges of deviation from manufacturer-stated specifications. The manufacturer, not a standard, determines how the hearing aid performs.

As a result, achieving optimal hearing aid performance currently depends in part on interpreting the technical data supplied by the manufacturer for selection and adjustment. The interpretation of this information is highly technical, so the information is useful to a professional but generally not the lay user. For OTC hearing aids, we believe that the devices must meet certain electroacoustic performance specifications so that any OTC hearing aid would perform safely and effectively for perceived mild to moderate hearing loss after the user customizes the device for individual needs. To that end, we are proposing to use several applicable specifications for device performance from ANSI/CTA-2051 for OTC hearing aids.

A device that met these performance specifications would safely and effectively reproduce sounds without the need for professional involvement. Specifically, an OTC hearing aid should provide amplification with high fidelity so that the user can accurately perceive daily social and environmental sounds. High-fidelity (accurate) output means that the device reproduces the input frequencies clearly, without distortion and without undue frequency shaping. We believe such an OTC hearing aid will have certain performance characteristics to achieve fidelity.

The OTC hearing aid would have sufficiently low distortion, would not introduce excessive self-generated noise or time delays between input and output, and would provide a sufficient frequency response bandwidth and smoothness. An OTC hearing aid would have to achieve these, after customization to the individual's hearing needs, without the intervention of a licensed professional. That is, by design. We have reviewed ANSI/CTA-2051:2017, which includes specifications for electroacoustic performance, and we believe that performance requirements based primarily on its Category 1 specifications would help provide reasonable assurance of safety and effectiveness of OTC hearing aids.[] These specifications relate to the device's processing of the input sound (the sounds detected by the device) to generate the output sound (the amplified sound that the device produces to assist the user).

To summarize, FDA believes that the specifications that would help provide reasonable assurance of safety and effectiveness, as well as set an objective baseline for device performance, are. Distortion control limits. Self-generated noise limits. Latency limit.

Frequency response bandwidth. And Frequency response smoothness limits. We believe that the above listed electroacoustic requirements would ensure that an OTC hearing aid can accurately reproduce daily speech and other environmental sounds without the need for professional involvement. We believe that this performance level is requisite for the device to meet the needs of people with perceived mild to moderate hearing loss.

Likewise, the performance requirements would help ensure that undesirable effects (such as distortion) do not impair safety and effectiveness. ANSI/CTA-2051 is, to FDA's knowledge, the first voluntary consensus standard to describe performance characteristics for hearing amplifiers (as opposed to standardized test methods and tolerances). Upon reviewing the voluntary consensus standard, and in consideration of related presentations during FDA's 2016 hearing aid workshop, we believe that the rationale and methodology of the standard are sound, and we believe that adhering to the specifications in this standard would yield high-fidelity OTC hearing aids. However, we are proposing to establish as requirements the subset of those specifications that we believe would help provide reasonable assurance of safety and effectiveness in conjunction with the other proposals in this rulemaking.

Whether to require such electroacoustic performance specifications for OTC hearing aids, and the specific values, were topics of discussion during the June 9, 2017, NASEM public workshop (Ref. 11). Additionally, public presentations of amplification measurements at FDA's hearing aid workshop showed performance differences and suitability in terms of frequency response bandwidth and smoothness across devices that presenters considered (Refs. 9, 15, 16, 22).

After seeing such information, several participants opined that the Category 1 limits of ANSI/CTA-2051, together with the device latency limits (a Category 2 limit in ANSI/CTA-2051), would collectively help ensure safety and effectiveness of an OTC hearing aid with respect to its electroacoustic performance. In addition to the performance aspects of the voluntary consensus standard, we recognize that aligning FDA regulations with a voluntary consensus standard may reduce administrative burdens while encouraging and facilitating greater availability of safe and effective OTC hearing aids. Note that we are not proposing to apply the electroacoustic performance requirements to Start Printed Page 58164 prescription hearing aids, nor are we proposing to establish requirements for OTC hearing aids that mirror the technical data requirements under current § 801.420(c)(4). We expect that the involvement of a licensed professional for prescription hearing aids will help provide for reasonable assurance of safety and effectiveness for those devices.

Similarly, although the technical data in current § 801.420(c)(4) will assist licensed professionals to select and fit a prescription hearing aid, we do not believe that the technical data are generally helpful for lay users of OTC hearing aids that meet electroacoustic performance requirements. a. Distortion control limits. Distortion control limits describe how faithfully an OTC hearing aid reproduces a given frequency or range of frequencies at a given sound pressure level.

An OTC hearing aid that produces less perceptible total harmonic distortion, plus hearing-aid-originated noise ( i.e., total harmonic distortion plus noise), will deliver a higher-fidelity sound to the user, meaning that the user will be able to perceive sounds more accurately or clearly than a device with higher perceptible total harmonic distortion plus noise. Total harmonic distortion plus noise can depend on both the input and output sound pressure levels and the corresponding (level-dependent) gain settings of the device if applicable. We believe that the proposed allowable levels of total harmonic distortion plus noise, when measured as proposed at the specified sound pressure levels, will help ensure accurate or clear amplification for the user of an OTC hearing aid. b.

Self-generated noise level limit. The self-generated noise level limit describes the maximum sound pressure level of noise that the OTC hearing aid may produce, where “self-generated noise” means sounds that are present in the output but not the input. Excessive self-generated noise can obscure or overwhelm softer output sounds, preventing the user from hearing such sounds. Excessive self-generated noise may also distract or annoy users.

Appropriately limiting self-generated noise will therefore help users to hear softer output sounds as well as improve their experience by avoiding the production of perceptible noise or sounds that are not input sounds. We believe that the proposed rule will appropriately limit self-generated noise. c. Latency limit.

The latency limit describes how quickly an OTC hearing aid produces the output sound relative to the input sound. A shorter latency interval means that the device takes less time to produce the output, and when short enough, the user will not perceive a delay. A perceived delay is generally most noticeable when the device amplifies the user's own voice, causing an effect much like an echo that can be disorienting, distracting, or annoying. We believe that the proposed latency limit will help to avoid perceptible output delays that would reduce the benefit from an OTC hearing aid.

d. Frequency response bandwidth. The frequency response bandwidth of an OTC hearing aid is the range of frequencies that the device can reproduce for the user to hear. Cutoff frequencies, both lower and upper, are the limits of the bandwidth.

The device would generally not sufficiently amplify signals with frequencies outside of these limits, meaning, below the lower cutoff or above the upper cutoff. A wider bandwidth means that the device can amplify a broader range of sound frequencies for users to hear. A bandwidth that is too narrow, especially if the upper cutoff is too low, will result in insufficient amplification of critical high-frequency sounds, including but not limited to speech sounds such as /s/,/z/,/t/, and/sh/. We believe that the proposed required frequency bandwidth, 250 Hz to 5 kHz, will ensure amplification of daily speech or other environmental sounds because almost all such sounds typically fall between these proposed lower and upper cutoff frequencies.

e. Frequency response smoothness limit. The frequency response smoothness limit describes how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth. A uniform frequency response when graphed would correspond to a smooth and relatively uniform curve, which is the “smoothness” described by this limit.

To describe this requirement, we divide the frequency range into multiple, narrower ranges called one-third octave bands. Any given peak in a one-third octave band would have to remain below a set level compared to neighboring bands, two bands above and two bands below, based on the averages. Meeting this requirement for frequency response smoothness means that the amplification performance is consistent across frequencies for users. If a device does not amplify sounds uniformly across frequencies, the user would potentially perceive differences in intensity for different frequencies, reducing the audio fidelity and consequently the user's hearing perception.

This may include a perceptibly altered speech quality (such as undue changes in the tone or timbre of the intended sound), which may be distracting or annoying. In addition, device output that is relatively excessive at lower frequencies (compared to higher frequencies) poses an increased risk for damaging a user's hearing at lower frequencies. This is because the typical user has more residual hearing ( i.e., better hearing thresholds) at lower frequencies, consistent with a typical sloping hearing loss, the kind of hearing loss associated with aging. We believe that the proposed frequency response smoothness limit will ensure consistent performance across frequency ranges and thereby help to provide reasonable assurance of device safety and effectiveness.

f. Performance test methods. For each of these proposed electroacoustic requirements, we are specifying performance test methods, including input and output sound pressure levels when appropriate. We are proposing specific performance test methods because different test methods could yield different results for the same metric of device performance.

Thus, specifying test methods helps establish a common baseline to benchmark performance for any given device. Additionally, a common baseline would allow prospective users and others to compare electroacoustic performance across devices. Facilitating comparison shopping may also promote users' satisfaction with the OTC hearing aids that they decide to purchase. 2.

Design Requirements To Ensure Proper Physical Fit and Prevent User Injury We are proposing that the design of an OTC hearing aid must meet certain requirements for safety and effectiveness. Maximum insertion depth. Eartip made from atraumatic materials. Proper physical fit.

And Tools, tests, or software allowing the lay user to control the device and customize it to the user's hearing needs. The above listed requirements seek to balance effective fit and safe fit of an OTC hearing aid, accomplished by users themselves, without professional assistance. An OTC hearing aid eartip (the part of the OTC hearing aid that contacts and fits into the user's ear) must fit the user so the device performs optimally, but an OTC hearing aid must not damage the ear, including the ear canal and eardrum (tympanic membrane). The device could damage the ear by scratching (abrading) the skin around the eartip parts, puncturing the eardrum, or exacerbating hearing loss if Start Printed Page 58165 the device is too close to the eardrum.

In particular, the skin that lines the ear canal is especially thin and delicate. The lateral (outer) third of the canal is composed of cartilage, and the medial (inner) two-thirds, which ends at the ear drum, of bone. Each of these parts of the ear is therefore quite sensitive and easily injured. To provide reasonable assurance of safety and effectiveness, the design of an OTC hearing aid must allow insertion and prolonged contact with these sensitive areas while preventing injury to them.

We believe the above listed requirements would ensure proper physical fit for optimal performance while avoiding injury to the user's ear canal skin, bony inner ear canal, the eardrum, or other middle ear structures. a. Maximum insertion depth. We considered whether we could express a design requirement for manufacturers for maximum insertion depth as a given length.

However, specific anatomical dimensions such as the length of the cartilaginous and bony portions of the external auditory canal and distance to the tympanic membrane can vary greatly among adults. That is, the distance to the eardrum differs greatly from person to person. A given length may be too long for one person (potentially resulting in injury with device insertion or placement) but too short for another (potentially impairing device performance by too shallow of an insertion). In contrast, we believe that the bony-cartilaginous junction is a readily identifiable and consistent anatomical landmark that can serve as a design limit for manufacturers of OTC hearing aids.

That is, we believe a practical way to describe the depth limit is to base it on the area of the ear canal corresponding to where cartilage meets bone. However, we welcome comments, particularly those with support from peer-reviewed sources, about other design requirements ( e.g., in terms of absolute length) to limit the insertion depth and prevent damage to the tympanic membrane or other injuries while also promoting device effectiveness. b. Construction from atraumatic materials.

We are proposing that the eartip be encased by atraumatic materials, that is, materials that prevent injuries to the skin and bone, for example, because they are very flexible. The use of atraumatic materials reduces the chance that daily use or accidental contacts will cause damage to the delicate skin or bone of the ear. c. Proper physical fit.

We are proposing that the OTC hearing aid have features that enable users to readily achieve a safe, customized, acoustically favorable, and comfortable physical fit in the ear canal and/or external ear. For example, the manufacturer may wish to provide interchangeable eartips of varying sizes. However, we are not proposing a specific design feature or strategy because such specificity may constrain the design of an OTC hearing aid and impede design innovations. This proposed requirement corresponds with the proposed labeling requirements to describe how users may obtain such a fit, including sizing or inserting the eartip to minimize the risk of injury.

d. Tools, tests, or software. We are proposing to codify the requirement that an OTC hearing aid must include tools, tests, or software through which a lay user can control the device and customize it to the user's hearing needs. Examples of tools, tests, or software include but are not limited to.

A user-adjustable volume control, a user-adjustable tone control, the ability for a user to change preset listening programs manually, interactive software for self-selecting, testing, and fitting, or a switch to enable or disable automatically determined settings, such as acoustic environment sensing or noise cancellation. An OTC hearing aid would need to include tools, tests, or software, or some combination of those features, sufficient to customize the device to meet the user's hearing needs. 3. QS Requirements We are soliciting further input on potential revisions to the applicable QS requirements for OTC hearing aids.

The input that we have already received, while valuable, is sometimes contradictory and does not fully address FDA's concerns for the quality of medical devices. As described in section I.C, we received stakeholder input suggesting that FDA reduce the provisions of the QS regulation applicable to the devices as the provisions are overly burdensome. We also received input that the current requirements are important and not unduly burdensome (Ref. 9).

While FDA wishes to minimize regulatory burdens, we must have reasonable assurance of safety and effectiveness, which a quality system helps to provide. In considering the range of feedback already received, we note that the QS requirements are interdependent yet inherently flexible. This scheme relies on each of the provisions working together. Further, because hearing aids are medical devices, a quality system for medical devices specifically, as opposed to a quality system for consumer electronics more generally, is necessary to provide reasonable assurance of safety and effectiveness.

This is because medical device quality systems address regulatory concerns regarding safety and effectiveness that systems for consumer electronics do not. While the use of the quality system described in part 820 would be more appropriate for OTC hearing aids and straightforward to implement than another standard with various reservations, exceptions, and modifications, FDA is open to considering alternatives to the existing QS requirements. Any such changes would be proposed in a separate rulemaking proceeding, and interested parties would have an opportunity to comment during that rulemaking. However, we welcome proposals for how the QS requirements could be modified, or an alternate approach implemented, to ensure the quality of OTC hearing aids and provide a reasonable assurance of safety and effectiveness.

Finally, with regard to the QS requirements, FDA is undertaking other separate efforts to minimize regulatory burdens for manufacturers by proposing the harmonization of part 820 with an international consensus standard. In light of the foregoing—including contradictory input already received, the inherent flexibility of the QS requirements, the need for a quality system suited to medical devices, and other changes that FDA is proposing—we are seeking further input on potential modifications to the QS requirements that would be applicable to OTC hearing aids to inform future rulemaking. F. Condition for Sale (Proposed § 800.30(g)) FDA is proposing to establish a condition for sale of OTC hearing aids to prevent sale to people younger than 18, helping to provide reasonable assurance of safety and effectiveness.

We are proposing the condition for sale pursuant to section 709(b)(2)(D) of FDARA, which directs FDA to describe the requirements under which the sale of OTC hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online. For the purposes of this provision, we interpret “sale” broadly to include, among other transactions, leases and rentals. The proposed condition for sale is consistent with 709(b)(2)(C) of FDARA and section 520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids are only intended for people age 18 and older. As described above, the use of OTC hearing aids in people younger Start Printed Page 58166 than 18 presents risks to health beyond those typically associated with use in older people.

Accordingly, we are proposing to prohibit the sale of an OTC hearing aid to or for a person younger than 18 years. FDA has considered whether other conditions for sale for OTC hearing aids are necessary in addition to the proposed labeling that includes conspicuous statements that OTC hearing aids are only intended for people age 18 and older. This proposed condition for sale provides a basis for comments on the subject. FDA also considered whether requirements on sellers to verify the age of purchasers or, in the case of online or mail-order sales, the age of the recipient, would promote the public health.

However, mindful that the current conditions for sale have been criticized as described above, we believe that a requirement to obtain proof of age could make hearing aids more difficult to obtain. For example, people with limited means or mobility may not have a government-issued photographic identification that shows their birthdate. Similarly, age verification for online or mail-order sales could impede delivery of OTC hearing aids or reduce the number of willing sellers, which could disproportionately affect OTC hearing aid access in remote or rural areas. Moreover, FDA does not expect high demand for OTC hearing aids from or for people younger than 18.

Thus, a requirement for age verification could impose a barrier to access, particularly for underserved populations, without a corresponding benefit to the public health. FDA welcomes your comments on whether a prohibition of sales to or for people younger than 18 years, without the need to verify age, would best promote access to OTC hearing aids while protecting the hearing health of people younger than 18 years. Alternatively, we welcome your comments on what other conditions for sale may protect the hearing health of people younger than 18 years. In the case of alternative conditions for sale, FDA is particularly interested in conditions that would not disproportionately burden underserved communities.

FDA is also interested in your comments on whether labeling, without the prohibition on sales, adequately protects the health of people younger than 18. We intend to minimize burdens and provide flexibility for sellers, while also protecting the hearing health of people younger than 18, helping to promote the public health by promoting the availability of OTC hearing aids for people who are 18 and older. G. Preemption Provisions (Proposed § 800.30(h)) FDA is proposing to codify the provisions regarding preemption and private remedies under section 709(b)(4) and (5) of FDARA to assist stakeholders in understanding the legal framework for OTC hearing aids.

These provisions are not codified in the FD&C Act, meaning they do not appear under Title 21 of the U.S. Code, but apply nonetheless. We believe that including these provisions in the Code of Federal Regulations will assist our stakeholders, who may not be as familiar with requirements that are not codified in the FD&C Act, such as these, by consolidating applicable requirements in one location that is more familiar. This may be particularly helpful because FDARA added to the existing preemption framework for devices.

In general, under section 521(a) of the FD&C Act, device requirements established by a State (or a political subdivision) are preempted when the requirements are different from, or in addition to, requirements applicable to the device under the FD&C Act and which relate to the safety or effectiveness of the device or to any other matter included in the requirements applicable to the device. FDA may by regulation grant or deny exemptions to this preemption in response to an application from a State (or political subdivision) under certain conditions specified in section 521(b) of the FD&C Act. Prior to the enactment of FDARA, FDA issued regulations in response to such applications, most of them relating to hearing aids, which are codified in part 808. However, section 709(b)(4) of FDARA established preemption specific to OTC hearing aids that is different from the general rule for preemption under section 521(a) of the FD&C Act.

Although FDARA did not explicitly address the existing exemptions from preemption related to hearing aids, section 709(b)(4) of FDARA applies preemption to any requirement of a State (or local government) specifically related to hearing products, that would restrict or interfere with commercial activity involving OTC hearing aids (which, as mentioned above, we will use as shorthand in this document for the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online), that is different from, in addition to, or otherwise not identical to, FDA's regulations issued under FDARA section 709(b). We are therefore proposing to amend the scope of part 808 to reflect the additional preemption set by FDARA (see section III.I.1). 1. FDARA Preempts State Regulation of OTC Hearing Aids Under FDARA section 709(b)(4), the OTC Hearing Aid Controls that are the subject of this rulemaking, proposed § 800.30, if finalized, would preempt any State or local requirement specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids, that is different from, in addition to, or otherwise not identical to, the OTC Hearing Aid Controls, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids.

FDA interprets section 709(b)(4) of FDARA, including the terms therein, as consistent with its purpose that State or local government requirements specifically related to hearing products not restrict or interfere with commercial activity involving OTC hearing aids. For example, we interpret this provision as preempting State or local requirements specifically related to hearing products that would restrict or interfere with leases, consignments, or deliveries of OTC hearing aids, though not explicitly mentioned in FDARA, because such activities fall within the commercial activity involving OTC hearing aids covered by the provision, in this example, within the marketing, sale, dispensing, use, and/or distribution. Further, the FDARA preemption provision applies to requirements specifically related to hearing products generally, as opposed to devices or hearing aids more specifically, where such requirements restrict or interfere with commercial activity involving OTC hearing aids. As explained, we do not interpret section 709(b) of FDARA as necessarily preempting State requirements regulating professional services such as speech pathology, audiology, or fitting.

A State could, for example, continue to regulate such professional services generally. However, to the extent State or local governments require that purchasers of OTC hearing aids seek those services, such requirements would be preempted by section 709(b)(4) of FDARA as interfering with or restricting commercial activity involving OTC hearing aids. The same would be true were a State, for example, to require providers to undertake an activity, such as certification and examination specific Start Printed Page 58167 to hearing aids, in order to sell OTC hearing aids. 2.

Generally Applicable State and Local Requirements Are Not Necessarily Preempted Under FDARA As noted in section III.B, FDA does not interpret FDARA to preempt generally applicable requirements. By “generally applicable,” we mean that the requirement relates to other products in addition to hearing products, to services not specific to hearing products, or to unfair trade practices in which the requirements are not limited to hearing products.[] Requirements that apply to any place of business that offers goods or services for sale would likely be generally applicable and therefore not preempted (see also § 808.1(d)(1)). Similarly, requirements that apply to certain places of business may be generally applicable provided the requirements do not attach on account of selling, or other commercial activity involving, hearing products. State or local requirements that make compliance with Federal regulations enforceable by State or local authorities would also not generally be preempted.

The examples below focus only on the FDARA preemption provision that applies to OTC hearing aids. a. Example 1. For example, any given pharmacy may be subject to certain State licensing requirements that apply regardless of whether the pharmacy sells OTC hearing aids.

It would not be exempt from such licensing requirements merely because it sells OTC hearing aids. Similarly, a requirement to include terms of sale or return on the receipt that applied also to the sales of other (non-hearing) products would not be preempted. b. Example 2.

In contrast, requirements that attach on account of the sale of hearing products (or would not attach but for the sale of hearing products), would not be “generally applicable.” For example, a requirement that any place of business must obtain a license or certification to sell OTC hearing aids would be a requirement specifically related to hearing products. In addition, it would serve to restrict or interfere with commercial activity involving OTC hearing aids and would be different from, in addition to, or not otherwise identical to, the regulations issued under section 709(b) of FDARA. Therefore, it would be preempted. A requirement may attach on account of the sale of hearing products in a more indirect manner as well, and if it was in effect different from, in addition to, or not otherwise identical to the terms of the statute or Federal regulations, and if it restricted or interfered with commercial activity involving OTC hearing aids, it would be preempted.

That is, a State or local requirement may appear on its face to be generally applicable, but if in practice it was specifically related to hearing products and would restrict or interfere with commercial activity involving OTC hearing aids, the State or local requirement would be preempted. c. Example 3. A requirement that a retailer may only sell OTC hearing aids when it has an audiologist on premises would require the involvement of a licensed person in at least some cases.

This requirement would restrict or interfere with commercial activity involving OTC hearing aids, including by requiring the involvement of a licensed person, and would be preempted. d. Example 4. Similarly, a requirement that sellers advise purchasers of any hearing aids, whether prescription or OTC, of specific medical information not required in the OTC Hearing Aid Controls would be preempted with respect to the sale of OTC hearing aids.

Although the requirement attaches on account of the sale of hearing aids more generally (not just OTC devices), it is “specifically related to hearing products” and would operate as a condition of sale that is different from, in addition to, or otherwise not identical to those proposed in this rulemaking. The requirement would also restrict or interfere with commercial activity involving OTC hearing aids. Therefore, the requirement would be preempted as applied to the sale of OTC hearing aids. e.

Example 5. A professional or ethical requirement that deemed a sale to be professional malpractice if the dispenser permitted the sale of any hearing aid without consultation would be preempted under FDARA. It specifically relates to hearing products and by requiring consultation prior to the sale of an OTC hearing aid, it would restrict or interfere with commercial activity involving OTC hearing aids even though the requirement on its face applies only to the dispenser (who must meet licensing requirements). f.

Example 6. A requirement that a seller maintain a statement of medical examination, in connection with the sale of a hearing product, would be preempted under FDARA because such a condition of sale would restrict or interfere with commercial activity involving an OTC hearing aid. Moreover, the requirement for a statement of medical evaluation would restrict or interfere with commercial activity involving OTC hearing aids by requiring the involvement of a licensed person during the course of the commercial activity. 3.

Requirements for Professionals and Establishments As with generally applicable requirements, we do not interpret section 709 of FDARA as generally prohibiting the regulation of professionals or establishments or exempting them from applicable professional requirements, even in the case that the professional or establishment only undertakes activities related to OTC hearing aids. Thus, a person that purports to be a specially licensed professional or establishment would be subject to applicable State and local requirements. Such requirements may include periodic professional examination or mandating the availability of testing equipment. FDA does, however, interpret section 709 of FDARA as preempting certain kinds of professional or establishment requirements.

To use one specific example, many States have established definitions for hearing aid fitters, dispensers, or other sellers and servicers. In some cases, State or local requirements may deem an individual or establishment to be a dispenser (or other defined term) by virtue of engaging in the sale of or providing services for hearing aids. That status in turn incurs legal obligations. As explained, we interpret section 709 of FDARA as preempting such requirements to the extent that they would require the involvement of a licensed person for consumers to access OTC hearing aids or would otherwise restrict or interfere with commercial activity involving (the servicing, marketing, sale, dispensing, use, customer support, or distribution of) OTC hearing aids.

For the reasons explained in section III.B regarding the definition of “licensed person,” we are specifying certain related terms that would not on their own, as they relate to OTC hearing aids, indicate professional or specialized obligations. For example, under the proposed definition of “licensed person,” identifying as a Start Printed Page 58168 hearing aid “dispenser” would not imply licensure. Note that we would consider a person identifying as a “licensed dispenser” to be subject to State or local requirements applicable to licensed dispensers and therefore considered a “licensed person” under section 709(b)(4) of FDARA. The examples below focus only on the FDARA preemption provision that applies to OTC hearing aids.

a. Example 7. In contrast to identifying as a dispenser (without using the word “licensed”), as proposed, identifying as an audiologist or hearing aid fitter, for example, may imply licensure, depending on State and local requirements. Thus, a person who advertises as an audiologist or hearing aid fitter—professional services that may be provided, but cannot be required to be provided, to sell OTC hearing aids—would be subject to State requirements that apply to audiologists or hearing aid fitters.

This would be true even if such an audiologist or fitter only sold OTC hearing aids. b. Example 8. In contrast, a person who advertises as a hearing aid dispenser or seller, and who only sells OTC hearing aids, cannot be required to obtain specialized licenses to engage in commercial activity involving OTC hearing aids.

c. Example 9. As in Example 7, a person who only sells OTC hearing aids but advertises as a licensed dispenser even though such licensing is not required to sell OTC hearing aids—the person purports to be a licensed person, not a “dispenser” more generally—would be subject to State or local requirements that apply to licensed dispensers. We are proposing a preemption provision that speaks specifically to professional requirements in order to clarify in the regulations that the servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids, on its own, does not obligate a person to obtain specialized licenses, certificates, or any other State or local sanction.

H. Proposed Repeal of Conditions for Sale and Modifications for Prescription Labeling (§§ 801.420, 801.421, 801.422) FDA is proposing to repeal the conditions for sale for hearing aids, § 801.421, because these would no longer be necessary. Currently, those conditions apply to all hearing aids, but section 520(q)(2) of the FD&C Act specifies that OTC hearing aids will be exempt from §§ 801.420 and 801.421 or any successor regulations. Instead of continuing to apply those conditions to non-OTC hearing aids, FDA is proposing to repeal them.

Additionally, FDA is proposing to remove the current labeling requirements for hearing aids in § 801.420 and issue prescription labeling requirements under § 801.422, which would be in addition to the prescription labeling requirements in § 801.109. The repeal of § 801.421 and the amendments to the labeling requirements (amending the current labeling requirements, moving them to a new section, and removing § 801.420) would have further regulatory implications. In proposing new § 801.422, FDA is not relying on its restricted device authority in section 520(e) of the FD&C Act. Therefore, if this proposed rule is finalized, class I and class II hearing aids would no longer be “restricted devices” under section 520(e) of the FD&C Act.

As such, certain Federal requirements related to restricted devices would no longer apply to class I and class II hearing aids. Further, the basis for some of FDA's exemption decisions about preempted State requirements would change. The next section of this document discusses those changes along with the additional Federal preemption implications of FDARA and how we would remove, update, or clarify those regulations. Repeal of the conditions for sale would also obviate the need for the guidance entitled “Conditions for Sale for Air-Conduction Hearing Aids”.

If the repeal of the conditions for sale is finalized, we would withdraw that guidance (Ref. 8). 1. Repeal of Conditions for Sale § 801.421 As summarized in section I.C.2, the conditions for sale of hearing aids under § 801.421 require a statement of medical evaluation, unless waived by a user 18 years of age or older.

The availability of a user instructional brochure and an opportunity to review it. And records of the statements of medical evaluation or waiver. The conditions also provide an exemption from the requirements in § 801.421 for auditory trainers. In light of the fact that FDA is proposing to clarify that non-OTC hearing aids would be prescription devices, such hearing aids would be subject to State and local requirements for obtaining written or oral authorization of a practitioner licensed by State law to administer the use of the devices.

For example, some States license audiologists to administer the use of prescription hearing aids for an adult, so adults could obtain a prescription for hearing aids from an audiologist in those States. In the case of people younger than age 18, the proposed prescription labeling statements described in the next section of this document would in manner and form emphasize the importance of medical evaluations. Because prescription hearing aids will require a written or oral authorization from a practitioner licensed by law to administer the device, and because we are proposing certain labeling requirements in a certain manner and form, FDA is proposing to repeal the conditions for sale (including the requirement for a medical evaluation and for providing a user instructional brochure) because they would no longer be necessary to provide reasonable assurance of safety and effectiveness of prescription hearing aids. Thus, hearing aids that do not meet the definition of, or the requirements for, OTC hearing aids would all be prescription hearing aids, but they would no longer be restricted devices.

We expect that the application of prescription requirements with the removal of device restrictions will not increase the burden to obtain non-OTC hearing aids, and that the change will promote consistency with other products, easing the burden on purchasers. Specifically, hearing aids will be either prescription or OTC. Users and other interested people would not also need to inquire whether a device is restricted. Additionally, repeal of the requirements discussed above would obviate the need for the exemption for group auditory trainers, which we are correspondingly proposing to repeal.

2. Revised Labeling for Prescription Hearing Aids We continue to believe that the labeling requirements are necessary to provide reasonable assurance of safety and effectiveness of prescription hearing aids. As such, we are proposing to retain most of the required information currently in § 801.420 in substance, except as revised below, and place the proposed revised labeling requirements that would be specific to prescription hearing aids in § 801.422, thereby removing § 801.420. These proposed revisions are to ensure that the wording is consistent with and similar to the proposed labeling statements for OTC hearing aids when appropriate.

In particular, we are proposing to revise the labeling statements to be more understandable and, when addressed to users and prospective users, less technical. In general, as summarized in section II, a device's labeling must bear adequate directions for use and certain adequate warnings in the manner and form necessary to protect the user (see section 502(f) of the FD&C Act). We Start Printed Page 58169 have defined “adequate directions for use,” in part, as directions by which a layperson can use the device safely and for the purposes for which it is intended (see § 801.5). However, we have exempted prescription devices from the requirement for labeling to bear adequate directions for use provided they meet certain conditions (see § 801.109).

For prescription devices, labeling must bear, among other statements, information for use under which practitioners licensed by law to administer the device can use it safely and for the purpose for which it is intended (see § 801.109(c)). In any case, the labeling for a device must not be false or misleading in any particular (see section 502(a)(1) of the FD&C Act). Labeling may be false or misleading because, among other reasons, it fails to reveal facts material to its use (see section 201(n) of the FD&C Act). Therefore, prescription hearing aid labeling must include certain adequate warnings as well as information for the licensed professional to use the device safely and for the purpose for which it is intended, and the labeling must not fail to reveal certain material facts.

To determine whether those requirements are met, we consider the sale, distribution, and use of prescription hearing aids. In the case of prescription hearing aids, a prospective user would obtain one from a practitioner licensed by law in that State. However, the professional qualifications for fitters and other licensed practitioners, as well as dispensers more generally, vary widely. Therefore, we are proposing to require information for dispensers to ensure necessary warnings are conveyed in an adequate manner and form for every device.

The proposal includes warnings. (1) Of possibilities for underlying pathological conditions, (2) against use in people younger than 18 without a medical evaluation, and (3) of injury potential from high output. We are further proposing to require the disclosure of certain technical specifications, which is necessary to provide fitters and dispensers information for the safe and effective use of the device. This information is material to the use of the device, as this information would be necessary for a hearing health professional to select an appropriate device.

Without this information, a hearing health professional would be unable to determine a safe and effective device for the user without unnecessarily increasing the risks to health to the user. This provision includes a proposed requirement that measurement of the specifications conforms to ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” to provide for uniformity in testing and measurement, which in turn aids hearing health professionals in selecting or fitting an appropriate prescription hearing aid. The proposed user labeling requirements are also intended to provide adequate warnings against use in certain pathological (“red flag”) conditions, and by children, where the use would be dangerous to health. As well as adequate warnings against unsafe dosage or methods or duration of administration or application.

We propose that this manner and form are necessary for the protection of the users. Once a user obtains a prescription hearing aid, use of the device occurs without direct supervision of a licensed professional, and notably, such use is generally intended to occur over long periods each day, every day. Therefore, in addition to the proposed information for hearing health professionals summarized above, we are proposing warnings and information specifically for users. We intend this information to be more understandable for laypeople while communicating warnings against use in certain pathological (“red flag”) conditions, against use in children without a medical evaluation, and in a manner and form that are necessary for the protection of the users.

For the reasons explained above, we believe that the proposed labeling requirements for prescription hearing aids are necessary to provide reasonable assurance of safety and effectiveness. This proposal also maximizes consistency with OTC hearing aid labeling to reduce the burden on manufacturers that wish to offer both categories of hearing aids. Although we are proposing the foregoing warnings and information in manner and form as are necessary for the protection of users, the specificity of this proposal would also encourage uniformity while conveying essential information appropriate for the type of hearing healthcare delivery. By minimizing burdens and fostering familiarity, the specificity and consistency would also help promote availability and use of prescription devices.

To provide for clarity and efficient enforcement of the FD&C Act, FDA is proposing to provide explicitly that a prescription hearing aid that does not satisfy the labeling requirements of proposed § 801.422, if finalized, would be misbranded under sections 201(n), 502(a), and 502(f) of the FD&C Act. Moreover, as explained, we believe that the labeling statements as we propose to revise them are material to and necessary for the safe and effective use of prescription hearing aids. Thus, we believe that an explicit misbranding provision in the prescription labeling requirements will provide for clarity as well as the efficient enforcement of the FD&C Act. If we finalize the repeal of the conditions for sale under § 801.421, we would correspondingly withdraw the guidance document entitled “Conditions for Sale for Air-Conduction Hearing Aids” because that guidance announces our policy regarding certain provisions of § 801.421 and would cease to be relevant (Ref.

8). I. Proposed Amendments to Previous Exemption Decisions (Part 808) A State or a political subdivision ( e.g., a city) may not establish or continue in effect its own requirement with respect to a device for human use if that requirement is different from, or in addition to, a requirement applicable under the FD&C Act to the device (see section 521(a) of the FD&C Act). Under section 521(b) of the FD&C Act, upon application of a State or political subdivision of a State, FDA may, by regulation, exempt from preemption a State or political subdivision requirement applicable to a device if.

(1) The requirement is more stringent than a requirement under the FD&C Act that would be applicable to the device if an exemption were not in effect or (2) the requirement is required by compelling local conditions and compliance with the requirement would not cause the device to be in violation of the FD&C Act. FDA has granted some exemption requests and most, if not all, of FDA's decisions to grant exemption from preemption were based on the State or local requirement being more stringent. FDA's decisions on States' applications for exemption from Federal preemption under section 521 of the FD&C Act are codified in regulations under part 808, subpart C. The regulations codifying these decisions include both granting and denial of exemption from preemption.

Therefore, “exemption decisions” as used in this document include both types of decisions. Most of the applications for exemption from Federal preemption related to State medical device requirements that apply to hearing aids, as they existed at the time of the exemption decisions, and that were different from or in addition to the requirements in §§ 801.420 and/or 801.421. Because FDARA directs FDA to establish different requirements for some hearing aids that are not subject to section 521(b) of the FD&C Act, many of the current exemption decisions would not accurately reflect the regulatory Start Printed Page 58170 framework for hearing aids under FDARA and the FD&C Act as amended. Moreover, if we finalize the changes we are proposing to the existing requirements for hearing aids in §§ 801.420 and 801.421, the previous exemption decisions based on those requirements may no longer apply.

1. Exemption Decisions Under Section 521(b) Are Affected by FDARA (Proposed § 808.1(g)) As explained in section III.G of this document, and as indicated above, some decisions on exemption from Federal preemption under section 521(b) of the FD&C Act would no longer accurately reflect the applicability of State requirements after the enactment of FDARA and upon establishing the OTC category of hearing aids. To assist stakeholders to understand the changes effected by FDARA, we are proposing to codify how FDARA limits the scope of exemption decisions under section 521(b) of the FD&C Act. We believe this proposal will provide a concise reference for stakeholders to ascertain the changes effected by FDARA.

Note that we are not considering exemptions from section 709(b)(4) of FDARA for State or local requirements. This is because FDARA does not provide a parallel mechanism to exempt State or local requirements regarding hearing products that would restrict or interfere with commercial activity involving OTC hearing aids. We refer to preemption under section 709(b)(4) simply to clarify how FDARA affects State and local requirements. 2.

Removal of Regulations Codifying Exemption Decisions Affected by Amendments to § 801.420 and Repeal of § 801.421 if Finalized As explained above, FDA's exemption decisions are codified in regulations under part 808, subpart C. These decisions were issued in the 1980s and apply to the specific State provisions identified in the regulations and the specific Federal requirements in effect at the time. As mentioned above, most of the exemption decisions related to State medical device requirements that apply to hearing aids and that were different from or in addition to the requirements in §§ 801.420 and/or 801.421. We are proposing to remove all of the regulations in part 808 related to hearing aids.

That is, almost all regulations codifying the previous decisions in §§ 808.53 through 808.101, except for the portions of § 808.55 (California) that do not relate solely to hearing aids. We are proposing this because the exemption decisions codified in those regulations may no longer apply due to changes to the Federal hearing aid requirements as proposed in this rulemaking and changes to the specific State provisions we have identified in those regulations since the decisions were made over 30 years ago. In particular, the repeal of the conditions for sale would eliminate specific Federal requirements that preempt certain State or local requirements. As such, whether we previously granted or denied exemptions, the exemption decisions would no longer apply because the State or local requirements that differed from, or were in addition to, § 801.421 would no longer be preempted.

Therefore, we are proposing to remove the State-specific regulations in part 808 codifying exemption decisions pertaining to the conditions for sale for hearing aids because those decisions would no longer be applicable if the conditions for sale are repealed. Also, the proposed amendments to the hearing aid labeling requirements may affect the exemption decisions relating to § 801.420. Although the proposed § 801.422 is similar to § 801.420 in that it too would address labeling for hearing aids, the labeling requirements are not identical to those in § 801.420 and include substantive changes. Moreover, FDA is aware that several States have modified their requirements that were the subject of the exemption decisions since they applied for exemptions, in which case the exemption decision may no longer be applicable.

Thus, not only will the Federal requirements change, but the State requirements that were the subject of the exemption decisions may have changed too since the decisions were made. Given that the exemption decisions were based on specific Federal requirements and specific State requirements that existed at the time of the decision, changes in either may affect those decisions such that they are no longer applicable. Because the exemption decisions relating to hearing aid labeling requirements may no longer be applicable, we are proposing to remove the regulations codifying these decisions. We specifically seek comments from the States regarding the proposed removal of the regulations in part 808, subpart C, codifying these exemption decisions.

For example, if a State disagrees with the proposed removal of the regulation(s) in part 808, subpart C, because the State believes the exemption decision still applies, a statement and explanation why in the comments may be helpful. We note that when § 801.422 is finalized and in effect, no State or political subdivision of a State may establish or continue in effect with respect to prescription hearing aids, any requirement which is different from, or in addition to, any requirement in § 801.422 (see section 521(a) of the FD&C Act). However, a State or political subdivision thereof may apply for an exemption from preemption by following the process in part 808 for any requirement that is preempted by § 801.422 (see also section 521(b) of the FD&C Act). J.

Other Proposed Amendments FDA is proposing several amendments to provide for consistency, including with the proposals in this rulemaking, if finalized, and to improve clarity. We are proposing the following. To realign the hearing aid classification regulations by sound conduction mode so that legacy air-conduction hearing aids, wireless air-conduction hearing aids, and self-fitting air-conduction hearing aids would be under one classification regulation. Bone-conduction hearing aids would be under a separate classification regulation.

To clarify that air-conduction hearing aids are subject to § 800.30 or § 801.422, as applicable, and bone-conduction hearing aids are subject to § 801.422. To revise the special control currently in § 874.3305(b)(1) for consistency with the special control currently in § 874.3325(b)(3). Although the proposed revision to § 874.3305(b)(1) would require demonstration of electrical safety and thermal safety, we believe that generally manufacturers of wireless air-conduction hearing aids regulated under § 874.3305 have been evaluating these safety aspects for their devices and therefore, this proposed revision would have little to no impact on these manufacturers. To revise the special controls for wireless hearing aids currently in § 874.3305(b) and for self-fitting hearing aids currently in § 874.3325(b) to eliminate redundancy, for example, removing special controls that would be addressed by the proposed labeling requirements for both OTC and prescription hearing aids.

To revise §§ 874.3315 and 874.3950 to clarify that these devices are subject to the prescription hearing aid labeling requirements, including in proposed § 801.422. • To clarify that a tympanic membrane contact hearing aid under § 874.3315 is a wearable device for Start Printed Page 58171 purposes of prescription hearing aid labeling. We are also proposing non-substantive modifications to the decisions regarding exemption from Federal preemption in part 808 to assist stakeholders to understand the subject matter of the individual exemption decisions. 1.

Realignment of Hearing Aid Classification Regulations by Sound Conduction Mode To increase clarity and to reduce administrative burdens associated with interpreting regulations, we are proposing to separate the classification regulations for bone-conduction and air-conduction hearing aids. We believe this will increase clarity because air-conduction devices are technologically more similar to each other than they are to bone-conduction devices. In addition, section 520(q)(1)(A)(i) defines an OTC hearing aid as a device that, among other criteria, uses the same fundamental scientific technology as air-conduction hearing aids that are wearable devices. Therefore, bone-conduction hearing aids do not fall within the scope of the OTC hearing aid definition and moving them to a separate classification regulation (proposed § 874.3301) will help make that clear.

Tympanic membrane contact hearing aids also do not fall within the scope of the OTC hearing aid definition because, among other reasons, they do not use the same fundamental scientific technology as air-conduction hearing aids, and as specified in § 874.3315, they will continue to be regulated as prescription devices. The proposed realignment of the air-conduction hearing aid types would also locate all OTC hearing aids within the same classification regulation. However, not all air-conduction hearing aids would be OTC hearing aids. For example, high-output air-conduction devices would be prescription.

Further, transcutaneous air conduction hearing aid systems entail surgical implantation of a tube to conduct sound, so we do not consider them suitable for OTC availability. The devices will continue to be regulated under § 874.3950. The realignment will not affect any device that does not use the same fundamental scientific technology, such as cochlear implants (product code MCM) or implantable middle ear hearing devices (product code MPV). In realigning the regulations by sound conduction mode, we are not proposing to reclassify any device or change the exemption status under section 510(m)(2) of the FD&C Act for premarket notification for any device type (see 21 U.S.C.

360(m)(2)). For example, wireless air-conduction hearing aids regulated under § 874.3305 would continue to be class II exempt, subject to the limitations of exemption in § 874.9, and special controls would continue to apply to these devices in addition to the general controls. (The proposed general controls under § 800.30 or § 801.422, if finalized, would also apply.) As of the effective date of the final rule, we would realign current product codes to correspond with the revised regulation numbers for consistency but would not otherwise change the codes. Also, we would change the name of each classification regulation to reflect the sound conduction mode.

Note that the regulation for air-conduction hearing aids would embody a split classification, where different devices under the regulation would have different classifications and special controls depending on the technology and design. As discussed above, we would also amend the wireless hearing aid special controls to provide for consistency with the special controls for self-fitting hearing aids, and we would amend the special controls for wireless hearing aids and self-fitting hearing aids to eliminate redundancy. 2. Non-Substantive Revisions to Exemption Decisions for Clarity and Ease of Use In addition to the amendments in part 808 explained in section III.I., we are proposing to amend the remaining State-specific regulation in part 808 to include paragraph headings that would appear in italics.

Currently, the regulations do not include paragraph headings and, as such, require stakeholders to look elsewhere to understand the content of the State or local requirements as they were at the time FDA made an exemption decision. The paragraph headings will assist stakeholders by briefly describing the subject of the individual exemption decisions, thereby providing additional information and context for stakeholders. IV. Findings Regarding Premarket Notification FDA may, in appropriate circumstances, exempt a class II device from premarket notification requirements under section 510(m)(2) of the FD&C Act.

Section 709(b)(3) of FDARA directs FDA to make such findings, that is, to determine whether OTC hearing aids require a report under section 510(k) to provide reasonable assurance of safety and effectiveness. As described in section I.B, legacy and wireless air-conduction hearing aids are exempt from section 510(k) subject to the limitations of exemption, and we are not proposing to alter the exemption status of such devices. Self-fitting air-conduction hearing aids are not currently exempt. FDA classified this device type in October 2019 (see 84 FR 57610), and the Agency does not have sufficient information or experience with this device type to exempt these devices from premarket notification.

Accordingly, FDA has determined that, at this time, reports under section 510(k) continue to be necessary to provide reasonable assurance of safety and effectiveness. We therefore do not propose to exempt them at this time. V. Proposed Effective and Compliance Dates A.

Effective Date FDA proposes that this rule, if finalized, be effective 60 days after the publication of the final rule in the Federal Register. We propose the following compliance dates. B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior to the Effective Date For hearing aids that have not been offered for sale prior to the effective date of the final rule, or have been offered for sale but are required to submit a new 510(k) under 21 CFR 807.81(a)(3), compliance with the new or revised requirements applicable to the hearing aid, and obtaining 510(k) clearance if applicable, must be achieved before marketing the device on or after the effective date of the final rule.

If a person ( e.g., manufacturer) markets such a device without complying with the new or revised requirements or if applicable, receiving 510(k) clearance, then FDA would consider taking action against such person under our usual enforcement policies. C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to the Effective Date For hearing aids that have been legally offered for sale prior to the effective date of the final rule, including those that already have a 510(k) clearance, compliance with the new or revised requirements that apply to the hearing aid must be achieved 180 days after the effective date of the final rule ( i.e., 240 days after the publication of the final rule). After that date, if a person ( e.g., manufacturer) continues to market such a device but does not comply with the new or revised requirements that apply to the device, then FDA would consider taking action Start Printed Page 58172 against such person under our usual enforcement policies.

At present, legacy and wireless air-conduction hearing aids are exempt from section 510(k) of the FD&C Act, subject to the limitations of exemption described in § 874.9. (Legacy hearing aids are class I devices and are 510(k) exempt under section 510( l )(1) of the FD&C Act.) However, self-fitting air-conduction hearing aids are not exempt and, therefore, are subject to premarket notification requirements. We believe that modifications to hearing aids, including labeling changes, to comply with the proposed OTC Hearing Aid Controls may exceed the limitations of exemption, for example because the device was formerly intended for use by healthcare professionals only. We believe that labeling changes for such hearing aids to comply with the proposed prescription hearing aid labeling requirements are less likely to exceed the limitations of exemption.

VI. Preliminary Economic Analysis of Impacts We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.

104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages. Distributive impacts. And equity).

Based on our preliminary analysis, OMB's Office of Information and Regulatory Affairs has determined that this proposed rule is an economically significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We believe we can certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. The estimated annualized cost over 10 years is $0.009 million per firm, which is unlikely to represent more than 3 percent to 5 percent of the revenue of an affected manufacturer.

However, we note that some uncertainty exists as to these impacts, so we have chosen to draft an initial regulatory flexibility analysis. We request comments relating to the effect of this proposed rule on small manufacturers. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The proposed rule, if finalized, would define a new regulatory category for OTC hearing aids and make corresponding changes to the existing regulatory framework, including defining hearing aids not meeting the proposed OTC requirements as prescription medical devices, as well as providing new labeling requirements for both OTC and prescription hearing aids. This proposed rule, if finalized, would generate potential cost savings for consumers with perceived mild to moderate hearing loss who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online. The proposed rule, if finalized, would also generate costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule. Table 3 summarizes our estimate of the annualized costs and the annualized benefits of the proposed rule, if finalized.

Table 3—Summary of Benefits, Costs and Distributional Effects of Proposed RuleCategoryPrimary estimateLow estimateHigh estimateUnitsNotesYear dollarsDiscount rate (%)Period covered (years)Benefits:Annualized Monetized $millions/year$63 63$6 6$147 1472020 20207 310 10Annualized Quantified7 3QualitativePotential increase in hearing aid and hearing technology use, leading to associated health benefits, potential fostering of innovation in hearing aid technology.Costs:Annualized Monetized $millions/year1 11 12 22020 20207 310 10Annualized Quantified7 3QualitativePotential loss of consumer utility from inability to buy existing hearing aids under existing conditionsTransfers:Federal Annualized Monetized $millions/year7 3From/ToFrom:To:Start Printed Page 58173Other Annualized Monetized $millions/year7 3From/ToFrom:To:Effects:State, Local or Tribal Government:Small Business:Wages:Growth. We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 23) and at https://www.fda.gov/​about-fda/​reports/​economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact FDA has carefully considered the potential environmental impact of this proposed rule and of possible alternative actions. In doing so, the Agency focused on the environmental impacts of its action as a result of increased use and eventual disposal of OTC hearing aids that will need to be handled if the proposed rule is finalized. The environmental assessment (EA) considers environmental impacts related to additional waste to landfills at municipal solid waste (MSW) facilities.

The proposed action would increase the availability and use of hearing aid devices, which would result in additional waste from increased disposal of these devices and their associated batteries and an increase in industrial waste associated with any domestic production to meet market demand for the new devices. Overall, given the current limited use of these devices, projected slow growth with increase in availability, and the small mass of waste material to be disposed or recycled, the proposed action is not expected to have a significant impact on MSW, landfill facilities, and the environment. The Agency has concluded that the proposed rule will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an EA prepared under 21 CFR 25.40, are on display with the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m.

And 4 p.m., Monday through Friday. They are also available electronically at https://www.regulations.gov. FDA invites comments and submission of data concerning the EA and FONSI. VIII.

Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). A description of these provisions is given in the Description section of this document with an estimate of the annual recordkeeping and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on these topics. (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected.

And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title. Medical Device Labeling Regulations. OMB Control Number 0910-0485—Revision.

Description. FDA is proposing to establish a regulatory category and related rules for OTC hearing aids to improve access to hearing aid technology for Americans. FDARA amended the FD&C Act by placing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls, which is what these rules would be. Alongside the OTC category, we are proposing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the eventual OTC category while continuing to provide a reasonable assurance of safety and effectiveness.

We believe the proposals set forth in this rulemaking will promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology. The set of general controls we are proposing, Over-the-Counter Hearing Aid Controls, would apply to all hearing aids that meet the definition of an OTC hearing aid under the FD&C Act, regardless of the device's class. Among other provisions, the controls would include requirements for labeling and device design, as well as a condition for sale to prevent the sale and use of the devices by people younger than age 18. We are also proposing to remove the labeling requirements in the existing restrictions but establish a new regulation for labeling specific to prescription hearing aids.

The new prescription labeling requirements would be similar to the current labeling requirements but maintain consistency with the new labeling requirements for OTC hearing aids (for example, so that “red flag” conditions, as revised, will be the same). We are proposing to repeal the other existing restrictions, i.e., the conditions of sale, because, if this rule is finalized as proposed, the new labeling requirements for prescription hearing aids, the requirement for a prescription, and other existing requirements would provide reasonable assurance of safety and effectiveness. Description of Respondents. Respondents to the information collection are manufacturers of hearing aids.

Start Printed Page 58174 We estimate the burden of the collection of information as follows. Table 4—Estimated One-Time Burden 1  2ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursTotal capital costsUnderstanding and implementing new regulatory requirements from hearing aids rule105110528429,820$4,100,000Hearing aids relabeling. One-time burden10588406857,1206,000,0001  There are no operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Table 5—Estimated Annual Recordkeeping Burden 1  2Activity.

21 CFR sectionNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursProposed labeling disclosures under 800.30(c)(2) and 801.422(c)(2). Hearing aids. Electronic version of user instructional brochure105884018401  There are no capital costs or operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Table 6—Estimated Annual Third-Party Disclosure Burden 1  2Activity.

21 CFR SectionNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursOTC Hearing Aid Controls—800.3010577351913,965Prescription Hearing Aid Labeling—801.4221051105191,995Total15,9601  There are no capital costs or operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Our burden estimate is based on FDA Uniform Registration and Listing System data. FDA's Operational and Administrative System for Import Support data. Informal communications with industry.

And our knowledge of and experience with information collection pertaining to medical device labeling. We intend the burden estimates to be consistent with our Preliminary Regulatory Impact Analysis (PRIA) for this rulemaking (Ref. 23). Estimated One-Time Burden.

OTC Hearing Aids proposed rule—one-time burden (Recordkeeping). As noted in the PRIA for this proposed rule, we estimate it will take 3 hours each for an executive, a lawyer, and a marketing manager to read and understand the rule. Also included in our estimate is time for revising guidelines or standard operating procedures. We assume this may take up to 25 hours for one executive, up to 100 hours for one marketing manager, and up to 150 hours for one technical writer.

Therefore, we estimate a one-time recordkeeping burden of 284 hours for each manufacturer. OTC Hearing Aids proposed rule — one-time relabeling burden (Third-Party Disclosure). The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840). The labeling cost model used in the PRIA suggests, based on a compliance period of 6 months, a one-time estimated third-party disclosure burden for relabeling of about 68 hours per product.

We request comments on these estimates. Estimated Annual Burden. Over-the-Counter Hearing Aid Controls—§ 800.30 (Recordkeeping and Third-Party Disclosure). Proposed § 800.30 sets forth labeling requirements for OTC hearing aids.

Proposed § 800.30(c)(1) describes the warnings and other important information that the outside package must bear. Additionally, manufacturers must include on the outside package label a weblink to all labeling and any additional resources, their return policy or lack thereof, and, if the OTC hearing aid is used or rebuilt, they must declare that fact. Proposed § 800.30(c)(2) describes device-specific requirements for labeling, inside the package. Among the labeling requirements listed are a user instructional brochure, an electronic version of which is to be made available for download.

Additional warnings. Caution and notices for users. Other specified information. And any other information necessary for adequate directions for use as defined in § 801.5.

Also required under proposed § 800.30(c)(2) is the identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician. The technical specifications required by § 800.30(c)(4). A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid. If applicable, information regarding repair service.

And, if applicable, a summary of all clinical or non-clinical studies Start Printed Page 58175 conducted to support the performance of the OTC hearing aid. Proposed § 800.30(c)(3) provides requirements for the labeling on an OTC hearing aid itself, specifically, name of the manufacturer, model name or number, serial number, and year of manufacture and if applicable, information regarding the battery. Also, if the OTC hearing aid is used or rebuilt, the manufacturer must physically attach a removable tag to the hearing aid declaring that fact. We include no estimate for provisions under proposed § 800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) and (B), and (c)(2)(iii)(A) through (D) because we consider the labeling to be “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public,” consistent with 5 CFR 1320.3(c)(2).

Thus, those labeling provisions are not within the definition of collection of information. The PRIA for this proposed rule estimates that 105 firms manufacture air-conduction hearing aids sold in the United States, based on FDA Medical Device Registration data. We estimate that each manufacturer has an average of eight products that would need relabeling. For each hearing aid product, we assume a 1-hour annual recordkeeping burden for maintaining the electronic version of the user instructional brochure (under proposed §§ 800.30(c)(2) and 801.422(c)(2)).

The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840) according to either the proposed OTC or prescription hearing aid labeling requirements. While we lack specific data regarding what portion of hearing aids will be relabeled as prescription devices and what portion will be relabeled as OTC hearing aids, for this analysis, we assume that 10 percent will be relabeled as prescription medical devices (about 1 product per manufacturer) and 90 percent as OTC hearing aids (about 7 products per manufacturer). The labeling cost model used in the PRIA suggests an annual estimated third-party disclosure burden of about 19 hours per product. We request comments on these estimates and assumptions.

Prescription Hearing Aid Labeling—§ 801.422 (Third-Party Disclosure). Proposed § 801.422(c) sets forth labeling requirements for prescription hearing aids. However, as with some of the provisions under proposed § 800.30(c), we include no estimate for provisions under proposed § 801.422(c)(1)(i)(A) and (B), (c)(2)(i)(A) through (C), and (c)(2)(ii)(A) through (E) because we consider the labeling to be “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public,” consistent with 5 CFR 1320.3(c)(2). Proposed § 801.422(c)(1) provides the warnings that must be on the outside package labeling and, if applicable, that the prescription hearing aid is used or rebuilt.

Proposed § 801.422(c)(2) describes requirements for prescription hearing aid labeling, inside the package. Among the labeling requirements listed are a user instructional brochure, an electronic version of which is to be made available for download. Additional warnings. Caution and notices for users.

And additional information that must be included in the user instructional brochure. Proposed § 801.422(c)(3) provides the requirements for the labeling on a prescription hearing aid itself, specifically, name of the manufacturer, model name or number, serial number, and year of manufacture. As well as information regarding the battery if applicable. And if the prescription hearing aid is used or rebuilt, the manufacturer must physically attach a removable tag to the hearing aid declaring that fact.

Proposed § 800.422(c)(4) provides the technical specification elements that must appear in the user instructional brochure or in separate labeling that accompanies the device. The PRIA estimates that 105 firms manufacture air conduction hearing aids sold in the United States, based on FDA Medical Device Registration data. We estimate that each manufacturer has an average of eight products that would need relabeling. For each hearing aid product, we assume a 1-hour annual recordkeeping burden for maintaining the electronic version of the user instructional brochure (under proposed §§ 800.30(c)(2) and 801.422(c)(2)).

The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840) according to either the proposed OTC or prescription hearing aid labeling requirements. While we lack specific data regarding what portion of hearing aids will be relabeled as prescription devices and what portion will be relabeled as OTC hearing aids, for this analysis, we assume that 10 percent will be relabeled as prescription medical devices (about 1 product per manufacturer) and 90 percent as OTC hearing aids (about 7 products per manufacturer). The labeling cost model used in the PRIA suggests an annual estimated third-party disclosure burden of about 19 hours per product. We request comments on these estimates and assumptions.

To ensure that comments on information collection are received, OMB recommends that written comments be submitted through https://www.reginfo.gov/​public/​do/​PRAMain (see ADDRESSES ). All comments should be identified with the title of the information collection. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review.

These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the Federal Register. IX. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132.

Section 4(a) of the Executive Order requires Agencies to “construe. . . A Federal statute to preempt State law only where the statute contains an express preemption provision or where there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from, or in addition to, any requirement applicable under” chapter V of the FD&C Act that is applicable to devices.

(See section 521 of the FD&C Act. Medtronic v. Lohr, 518 U.S. 470 (1996).

And Riegel v. Medtronic, 552 U.S. 312 (2008)). Federal law also preempts State or local laws “specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of [OTC hearing aids] through in-person transactions, by mail, or online, that [are] different from, in addition to, or otherwise not identical to, the regulations promulgated under” section 709(b) of FDARA (see section 709(b)(4) of FDARA).

Section 521(b) of the FD&C Act provides that the Commissioner of Food and Drugs may, upon application of a State or local government, exempt a requirement from preemption, if the State or local requirement for the device is more stringent than the requirement Start Printed Page 58176 under the FD&C Act, or if the requirement is necessitated by compelling local conditions and compliance with it would not cause the device to be in violation of a requirement under the FD&C Act.” Following this process, and if this rule becomes final, a State or local government may request an exemption from preemption for those State or local requirements pertaining to hearing aid products that are preempted by the Agency's final rule under section 521 of the FD&C Act. However, because FDARA does not provide a parallel mechanism to exempt State or local requirements from its express preemption provision, FDA is not considering exemptions under section 709(b)(4) of FDARA for OTC hearing aids. Thus, if this proposed rule is made final, the final rule would create requirements that fall within the scope of section 521 of the FD&C Act and/or section 709(b)(4) of FDARA. If made final, it would also amend § 801.420 and repeal § 801.421, and such changes would affect many of the decisions on applications for exemption from preemption that were issued in relation to these two regulations under section 521(b) of the FD&C Act, resulting in the removal of the regulations codifying such decisions, as discussed further in section III.I.

Above. The scope of preemption of this proposed rule, if finalized, is discussed in more detail in sections III.G through I, above. X. Consultation and Coordination With Indian Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175.

We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action. XI. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m.

And 4 p.m., Monday through Friday. They are also available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed.

References without asterisks are available for viewing only with the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time. 1. Lin, F., J.

Niparko, and L. Ferruci, “Hearing Loss Prevalence in the United States.” Archive of Internal Medicine, 171:1851-1853, 2011. 2. Dalton, D.S., “The Impact of Hearing Loss on Quality of Life in Older Adults.” The Gerontologist, 43(5):661-668, 2005.

*3. NIH. Hearing Aids Fact Sheet. National Institute on Deafness and Communication Disorders.

2010. Available at. Https://www.nidcd.nih.gov/​health/​statistics/​quick-statistics-hearing. 3a.

Maharani, A., Dawes, P., et al., “Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans.” Journal of the American Geriatrics Society, 66(6):1130-1136, 2018. 3b. Mahmoudi, E., Basu, T., et al., “Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Americans?. € Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.

4. McCormack, A. And H. Fortnum, “Why Do People Fitted With Hearing Aids Not Wear Them?.

€ International Journal of Audiology, 52(5):360-368, 2013. *5. Gudmundsen, G., Citizen Petition, FDA-2003-P-0342. Received August 11, 2003.

6. NASEM, “Hearing Health Care for Adults. Priorities for Improving Access and Affordability.” Board on Health Sciences Policy, Committee on Accessible and Affordable Hearing Health Care for Adults. Blazer, D.G., S.

Domnitz, and C.T. Liverman, Eds., 2016. DOI. 10.17226/23446.

Available at. Https://www.nap.edu/​catalog/​23446/​hearing-health-care-for-adults-priorities-for-improving-access-and. *7. Executive Office of the President.

€œAging America &. Hearing Loss. Imperative of Improved Hearing Technologies.” PCAST. 2015.

Available at. Https://obamawhitehouse.archives.gov/​sites/​default/​files/​microsites/​ostp/​PCAST/​pcast_​hearing_​tech_​letterreport_​final.pdf. *8. FDA, “Immediately in Effect Guidance Document.

Conditions for Sale for Air-Conduction Hearing Aids.” Guidance for Industry and Food and Drug Administration Staff. December 12, 2016. Available at. Https://www.fda.gov/​downloads/​medicaldevices/​deviceregulationandguidance/​guidancedocuments/​ucm531995.pdf.

*9. FDA, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” public workshop. Silver Spring, MD. April 21, 2016.

Available at. Https://wayback.archive-it.org/​7993/​20171114234227/​https://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm480336.htm. *10. Wallhagen, M., “HLAA Response to Call for Comment.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.

Silver Spring, MD. April 21, 2016. Available at. Https://wayback.archive-it.org/​7993/​20171115155122/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497333.pdf.

11. NASEM, “Over-The-Counter Hearing Devices Discussion. Safety and Quality Requirements and Considerations Session.” MP3, 1:15:39 (English). National Academies' Hearing Health Care Report.

June 2017 Dissemination Meeting. Washington, DC, 2017. *12. Lintz, J.S., “FDA Testimony.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.

Silver Spring, MD. April 21, 2016. Available at. Https://wayback.archive-it.org/​7993/​20171114234227/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM500626.pdf.

13. ANSI/CTA 2051. Personal Sound Amplification Performance Criteria (voluntary consensus standard). 2017.

Available at. Https://webstore.ansi.org/​standards/​ansi/​cta20512017ansi. *14. NIOSH, Occupational Noise Exposure, publication number 98-126.

June 1998. Available at. Https://www.cdc.gov/​niosh/​docs/​98-126/​pdfs/​98-126.pdf. *15.

Killion, M.C., “Presentation on the Work of the CTA PSAP Standard Committee.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD. April 21, 2016. Available at.

Https://wayback.archive-it.org/​7993/​20171115155142/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497364.pdf. *16. Laureyns, M., “The Potential Risk of Using PSAPs.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD.

April 21, 2016. Available at. Https://wayback.archive-it.org/​7993/​20171115155108/​https:/www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497406.pdf. 17.

Dillon, H., Hearing Aids. 2nd ed. New York, NY. Thieme Publishers, 2012.

18. Kuk, F.K., “Theoretical and Practical Considerations in Compression Hearing Aids.” Trends in Amplification, 1(1):5-39, 1996. *19. Bose, “Hearing Health and Technology Workshop,” public comment, P171200 #00140, to FTC.

Received May 18, 2017. Available at. Https://www.ftc.gov/​policy/​public-comments/​2017/​05/​18/​comment-00140. 20.

Hearing Review, “NASEM Committee Looks at Regulations for OTC Hearing Devices.” June 12, 2017. Available at. Https://www.hearingreview.com/​2017/​06/​nasem-committee-looks-regulations-otc-hearing-devices/​. 21.

Starkey Hearing Technologies, The Compression Handbook. An Overview of the Characteristics and Applications of Compression Amplification. 4th ed., 2017. Visit https://starkeypro.com/​pdfs/​The_​Compression_​Handbook.pdf.

Start Printed Page 58177 22. Smith, C., L.A. Wilber, and K. Cavitt, “PSAPs vs Hearing Aids.

An Electroacoustic Analysis of Performance and Fitting Capabilities.” Hearing Review, June 14, 2016, 2016. Available at. Https://www.hearingreview.com/​2016/​06/​psaps-vs-hearing-aids-electroacoustic-analysis-performance-fitting-capabilities/​. *23.

FDA, “Preliminary Regulatory Impact Analysis. Initial Regulatory Flexbility Analysis. Unfunded Mandates Reform Act Analysis.” 2019. Available at.

Https://www.fda.gov/​AboutFDA/​ReportsManualsForms/​Reports/​EconomicAnalyses/​default.htm. Start List of Subjects 21 CFR Part 800 Administrative practice and procedureIncorporation by referenceMedical devicesOphthalmic goods and servicesPackaging and containersReporting and recordkeeping requirements 21 CFR Part 801 Incorporation by referenceLabelingMedical devicesReporting and recordkeeping requirements 21 CFR Part 808 Intergovernmental relationsMedical devices 21 CFR Part 874 Medical devices End List of Subjects Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR parts 800, 801, 808, and 874 be amended as follows. Start Part End Part Start Amendment Part1. The authority citation for part 800 is revised to read as follows.

End Amendment Part Start Authority 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j, 360k, 361, 362, 371. End Authority Section 800.30 also issued under Sec. 709, Pub.

L. 115-52, 131 Stat. 1065-67. Start Amendment Part2.

Add § 800.30 to subpart B to read as follows. End Amendment Part Over-the-Counter Hearing Aid Controls. (a) Scope. This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids.

Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act and do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation. (b) Definitions for the purposes of this section.

This section uses the following definitions. Air-conduction hearing aid. An air-conduction hearing aid is a hearing aid that conducts sound to the ear through the air. Hearing aid.

A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Licensed person. A licensed person is a person as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a license or degree for the diagnosis, assessment, or treatment of hearing loss. Or that holds a license to sell or distribute hearing aids.

A person that must meet generally applicable licensing or operating requirements such as annual health and safety inspections, provided the generally applicable licensing or operating requirement is consistent with this section and other applicable requirements under the Federal Food, Drug, and Cosmetic Act, is not a “licensed person” solely for that reason. A person that represents as a marketer, seller, dispenser, distributor, or customer support representative (or an equivalent description) is not a “licensed person” solely by making such representations. Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid is an air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment.

The device, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. The device may use wireless technology or may include tests for self-assessment of hearing loss. The device is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section. Prescription hearing aid.

A prescription hearing aid is a hearing aid that is not an OTC hearing aid as defined in this section or a hearing aid that does not satisfy the requirements in this section. Sale. Sale includes a lease, rental, or any other purchase or exchange for value. Tools, tests, or software.

Tools, tests, or software are components of the device that, individually or in combination, allow a lay user to control the device and customize it sufficiently, such as the device's output, to meet the user's hearing needs. Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user.

A hearing aid evaluation is “bona fide” if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination. (c) Labeling. An OTC hearing aid shall bear all of the following in the labeling. (1) Outside package labeling.

The outside package of an OTC hearing aid shall bear all of the following. (i) Warnings and other important information. All of the following shall appear on the outside package. Start Printed Page 58178 Start Printed Page 58179 (ii) Statement of build condition.

If the OTC hearing aid is used or rebuilt, the outside package shall declare that fact. A sticker under and visible through the outer wrapper will suffice to declare such fact. (2) Labeling, inside the package. The manufacturer or distributor of an OTC hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service.

The user instructional brochure shall include all of the following. (i) The following warnings, which shall appear in the following order and prior to any content except the cover page. Start Printed Page 58180 (ii) Any additional warnings the manufacturer may include prior to the caution and notices to users in paragraph (c)(2)(iii) of this section. (iii) The following caution and notices for users, which shall appear prior to any content except the cover page and the warnings under paragraphs (c)(2)(i) and (ii) of this section.

Start Printed Page 58181 Start Printed Page 58182 (iv) An illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and the battery compartment. (v) Information on the function of all controls intended for user adjustment. (vi) A description of any accessory that accompanies the OTC hearing aid, including but not limited to wax guards and accessories for use with a computer, television, or telephone. (vii) Specific instructions for all of the following.

(A) Instructions for sizing or inserting the eartip of the OTC hearing aid to prevent insertion past the bony-cartilaginous junction of the external auditory canal and damage to the tympanic membrane. (B) The tools, tests, or software that allow the user to control the OTC hearing aid, including self-select, self-fit, and self-check the performance of the OTC hearing aid, and customize it to the user's hearing needs, including information about properly fitting eartips. (C) Use of the OTC hearing aid with any accompanying accessories. (D) Maintenance and care of the OTC hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time.

(E) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries. (F) Expected battery life. (G) Any other information necessary for adequate directions for use as defined in § 801.5. (viii) Identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax).

(ix) The technical specifications required by paragraph (c)(4) of this section. (x) A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid, including but not limited to ear wax buildup, drops, immersion in water, or exposure to excessive heat. (xi) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xii) If the manufacturer provides a repair service or licenses or certifies third-party repair services, information on how and where to obtain repair service, including at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service.

(xiii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies. (3) Labeling on the device. The labeling on an OTC hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section. (i) The serial number.

(ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the OTC hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact. (4) Technical specifications. All of the following technical specifications shall appear in the user instructional brochure that accompanies the device.

You may additionally include it on the outside package. (i) The maximum output limit value (OSPL90). (ii) The full-on gain value, which is the gain with a 50 dB SPL pure-tone input and volume set to full on. (iii) The total harmonic distortion value.

(iv) The self-generated noise value. (v) The latency value. (vi) The upper and lower cutoff frequencies for bandwidth. (d) Output limits.

The output limit for an OTC hearing aid shall be the device maximum acoustic output sound pressure level (SPL) in a 2-cubic centimeter (cm3 ) coupler when the device input is a 90 dB SPL pure-tone, and the gain/volume control is full on. An OTC hearing aid shall not exceed the following limits. (1) General output limit. An OTC hearing aid shall not exceed an output limit of 115 dB SPL at any frequency except as provided in paragraph (d)(2) of this section.

(2) Output limit for a device with input-controlled compression and user-adjustable volume control. An OTC hearing aid that includes input-controlled compression and a user-adjustable volume control shall not exceed an output limit of 120 dB SPL at any frequency. (e) Electroacoustic performance limits. An OTC hearing aid shall perform within all of the following electroacoustic limits.

Measure each electroacoustic performance characteristic using a 2-cm3 coupler where applicable. (1) Output distortion control limits. Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section. (i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method.

Start Printed Page 58183 (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL. Or (B) Using a 500-Hz one-third-octave pulsed-noise signal, measure at 67 dB SPL and 97 dB SPL. (ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid. (iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs.

(2) Self-generated noise level limits. Self-generated noise shall not exceed 32 dB SPL. You must disable any methods that artificially lower the apparent noise floor for the measurement. Such methods would include but are not limited to auto-muting and downward expansion.

(3) Latency. Latency shall not exceed 15 ms. You must measure the latency with a method that is accurate and repeatable to within 1.5 ms. (4) Frequency response bandwidth.

The lower cutoff frequency shall extend to 250 Hz or below, and the upper cutoff frequency shall extend to 5 kHz or greater. You must measure the frequency response bandwidth as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (5) Frequency response smoothness. No single peak in the one-third-octave frequency response shall exceed 12 dB relative to the average levels of the one-third-octave bands, two-thirds octave above and below the peak.

You must measure the frequency response smoothness using values for a diffuse field and the corrected one-third-octave frequency insertion response as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (f) Design requirements. An OTC hearing aid must conform to all of the following design requirements. (1) Insertion depth.

The design of an OTC hearing aid shall limit the insertion of the eartip to the bony-cartilaginous junction of the external auditory canal and no deeper. (2) Use of atraumatic materials. The material for the eartip of an OTC hearing aid shall be atraumatic. (3) Proper physical fit.

The OTC hearing aid shall be designed to enable consumers to readily achieve a safe, customized, acoustically favorable, and comfortable physical fit in the ear canal and/or external ear. (4) Tools, tests, or software. The OTC hearing aid shall, through tools, tests, or software, permit a lay user to control the device and customize it to the user's hearing needs. (g) Condition for sale of an OTC hearing aid.

The sale of an OTC hearing aid to or for a person younger than 18 years of age is prohibited. (h) Effect on State law. Any State or local government requirement for an OTC hearing aid is preempted to the following extent. (1) Preemption.

No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations issued under section 709(b) of the FDA Reauthorization Act of 2017, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids. (2) Professional requirements. €”(A) General rule. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids, or an equivalent activity, whether through in-person transactions, by mail, or online, shall not cause, require, or otherwise obligate a person providing such services to obtain specialized licensing, certification, or any other State or local sanction unless such requirement is generally applicable to the sale of any product or to all places of business regardless of whether they sell OTC hearing aids.

However, although a State or local government may not require the order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids, a licensed person may service, market, sell, dispense, provide customer support for, or distribute OTC hearing aids. (B) Sale of OTC hearing aids is not an exemption. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids does not exempt a person from any State or local government's professional or establishment requirements that are consistent with this section. (C) Representations may create professional obligations.

A person shall not incur specialized obligations by representing as a servicer, marketer, seller, dispenser, customer support representative, or distributor (or an equivalent description) of OTC hearing aids. However, a person representing as any other defined professional or establishment, or as a State licensed dispenser, is subject to applicable State and local requirements even if the person undertakes commercial or professional activities only in relation to OTC hearing aids. (3) Private remedies. This section does not modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.

(i) Incorporation by reference. (A) The standard required in this section is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html. (B) ANSI.

The American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036, storemanager@ansi.org, https://www.ansi.org, 202-293-8020. ( 1 ) ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” clause 4.1, dated January 2017. ( 2 ) [Reserved] (ii) [Reserved] Start Part End Part Start Amendment Part3. The authority citation for part 801 is revised to read as follows.

End Amendment Part Start Authority 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374. End Authority Start Amendment Part4. Remove § 801.420.

End Amendment Part Start Amendment Part5. Remove § 801.421. End Amendment Part Start Amendment Part6. Add § 801.422 to subpart H to read as follows.

End Amendment Part Prescription hearing aid labeling. (a) Scope. This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device.

Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the Start Printed Page 58184 applicable classification regulation. This section does not apply to group auditory trainers. (b) Definitions for the purposes of this section. This section uses the following definitions.

Dispenser. A dispenser is any person, as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of prescription hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person. Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.

Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an over-the-counter (OTC) hearing aid as defined in § 800.30 of this chapter or a hearing aid that does not satisfy the requirements in § 800.30 of this chapter. Sale. Sale includes a lease, rental, or any other purchase or exchange for value.

Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is “bona fide” if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination.

(c) Labeling. A prescription hearing aid shall bear all of the following labeling. (1) Outside package labeling. The outside package of a prescription hearing aid shall bear all of the following.

(i) Warnings. All of the following shall appear on the outside package. Start Printed Page 58185 (B) Statement of build condition. If the prescription hearing aid is used or rebuilt, the outside package shall declare that fact.

A sticker under and visible through the outer wrapper will suffice to declare such fact. (2) Labeling, inside the package. The manufacturer or distributor of a prescription hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service. The user instructional brochure shall include all of the following.

(i) The following warnings, which shall appear in the following order and prior to any content except the cover page. Start Printed Page 58186 Start Printed Page 58187 Start Printed Page 58188 (iii) An illustration(s) of the prescription hearing aid that indicates operating controls, user adjustments, and the battery compartment. Start Printed Page 58189 (iv) Information on the function of all controls intended for user adjustment. (v) A description of any accessory that accompanies the prescription hearing aid, including but not limited to wax guards, and accessories for use with a computer, television, or telephone.

(vi) Specific instructions for all of the following. (A) Use of the prescription hearing aid with any accompanying accessories. (B) Maintenance and care of the prescription hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time. (C) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries.

(D) Expected battery life. (vii) Identification of any known physiological side effects associated with the use of the prescription hearing aid that may warrant consultation with a physician, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax). (viii) The technical specifications required by paragraph (c)(4) of this section unless such specifications appear in separate labeling accompanying the prescription hearing aid. (ix) A description of commonly occurring, avoidable events that could adversely affect or damage the prescription hearing aid, including but not limited to ear wax buildup, drops, immersion in water, or exposure to excessive heat.

(x) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xi) If the manufacturer provides a repair service or licenses or certifies third-party repair services, information on how and where to obtain repair service, including at least one specific address where the user can go or send the prescription hearing aid to obtain such repair service. (xii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the prescription hearing aid, a summary of all such studies. (3) Labeling on the device.

The labeling on a prescription hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section. (i) The serial number. (ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the prescription hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact.

(4) Technical specifications. Technical specifications useful in selecting, fitting, and checking the performance of the prescription hearing aid shall appear in the user instructional brochure or in separate labeling that accompanies the device. You must determine the technical specification values for the prescription hearing aid labeling in accordance with the test procedures of the American National Standard, “Specification of Hearing Aid Characteristics,” ANSI/ASA S3.22-2014. As a minimum, the user instructional brochure or such other labeling shall include the appropriate values or information for the following technical specification elements as these elements are defined or used in such standard.

(i) Saturation output curve (SSPL 90 curve). (ii) Frequency response curve. (iii) Average saturation output (HF-Average SSPL 90). (iv) Average full-on gain (HF-Average full-on gain).

(v) Reference test gain. (vi) Frequency range. (vii) Total harmonic distortion. (viii) Equivalent input noise.

(ix) Battery current drain. (x) Induction coil sensitivity (telephone coil aids only). (xi) Input-output curve (only for hearing aids with automatic gain control). (xii) Attack and release times (only for hearing aids with automatic gain control).

(5) Misbranding. A prescription hearing aid that is not labeled as required under this section and § 801.109 of this chapter shall be misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and Cosmetic Act. (d) Incorporation by reference. (1) The standard required in this section is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C.

552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA).

For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html.. (2) ANSI. The American National Standards Institute, 1889 L Street NW, 11th Floor, Washington, DC 20036, storemanager@ansi.org, https://www.ansi.org, 202-293-8020. (i) ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” dated November 2014.

(ii) [Reserved] Start Part End Part Start Amendment Part7. The authority citation for part 808 is revised to read as follows. End Amendment Part Start Authority 21 U.S.C. 360j, 360k, 371.

End Authority Section 808.1 also issued under Sec. 709, Pub. L. 115-52, 131 Stat.

1065-67. Start Part End Part Start Amendment Part8. In part 808, remove the words “the act” and add in their place “the Federal Food, Drug, and Cosmetic Act”. End Amendment Part Start Amendment Part9.

In § 808.1, add headings to paragraphs (a) through (f) and add paragraph (g) to read as follows. End Amendment Part Scope. (a) Introduction. * * * (b) General rule for State and local requirements respecting devices.

* * * (c) Exempting from preemption certain State or local requirements respecting devices. * * * (d) Meaning of “requirements applicable to a device.” * * * (e) Determination of equivalence or difference of requirements applicable to a device. * * * (f) Applicability of Federal requirements respecting devices. * * * (g) Exemptions not applicable to certain State or local government requirements specifically related to hearing products.

An exemption under this part shall not apply to any State or local government law, regulation, order, or other requirement specifically related to hearing products, including any requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids, that. (1) Would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of Start Printed Page 58190 over-the-counter hearing aids, as defined under section 520(q) of the Federal Food, Drug, and Cosmetic Act, through in-person transactions, by mail, or online. And (2) Is different from, in addition to, or otherwise not identical to, the regulations issued under section 709(b) of the FDA Reauthorization Act of 2017. Start Amendment Part10.

Revise § 808.3 to read as follows. End Amendment Part Definitions. Compelling local conditions includes any factors, considerations, or circumstances prevailing in, or characteristic of, the geographic area or population of the State or political subdivision that justify exemption from preemption. More stringent refers to a requirement of greater restrictiveness or one that is expected to afford to those who may be exposed to a risk of injury from a device a higher degree of protection than is afforded by a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.

Political subdivision or locality means any lawfully established local governmental unit within a State which unit has the authority to establish or continue in effect any requirement having the force and effect of law with respect to a device intended for human use. State means any State or Territory of the United States, including but not limited to, the District of Columbia and the Commonwealth of Puerto Rico. Substantially identical to refers to the fact that a State or local requirement does not significantly differ in effect from a Federal requirement. [Removed and Reserved] Start Amendment Part11.

Remove and reserve § 808.53. End Amendment Part Start Amendment Part12. Revise § 808.55 to read as follows. End Amendment Part California.

The following California medical device requirements are preempted under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and FDA has denied them exemption from preemption. (a) Medical devices. General provisions. Sherman Food, Drug, and Cosmetic Law, Division 21 of the California Health and Safety Code, sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to the extent that they apply to devices.

And (b) Ophthalmic devices. Quality standards. California Business and Professions Code, section 2541.3 to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2. [Removed and Reserved] Start Amendment Part13.

Remove and reserve §§ 808.57 through 808.101. End Amendment Part Start Part End Part Start Amendment Part14. The authority citation for part 874 continues to read as follows. End Amendment Part Start Authority 21 U.S.C.

351, 360, 360c, 360e, 360j, 360l, 371. End Authority Start Amendment Part15. Redesignate § 874.3300 as § 874.3301 and revise to read as follows. End Amendment Part Bone-conduction hearing aid.

(a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that transmits sound to the inner ear through the skull. A bone-conduction hearing aid is subject to the requirements in § 801.422 of this chapter. (b) Classification.

Class II. Start Amendment Part16. Revise § 874.3305 to read as follows. End Amendment Part Air-conduction hearing aid.

(a) Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid may be wireless, self-fitting, or both. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.

Air-conduction hearing aid generic types exclude the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively. (b) Classification. (1) Legacy hearing aid. Class I for an air-conduction hearing aid that is not a wireless or self-fitting device.

This hearing aid is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. (2) Wireless hearing aid. Class II (special controls) for an air-conduction hearing aid that incorporates wireless technology in its programming or use. A wireless hearing aid may also be a self-fitting hearing aid.

A wireless hearing aid that is not a self-fitting hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. The special controls for a wireless hearing aid are. (i) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. (ii) Performance testing must validate safety of exposure to non-ionizing radiation.

And (iii) Performance data must validate wireless technology functions. (3) Self-fitting hearing aid. Class II (special controls) for a wireless air-conduction hearing aid that incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fittings and settings.

A self-fitting hearing aid is not exempt from premarket notification procedures, notwithstanding the exemption in paragraph (b)(2) of this section. The special controls for a self-fitting hearing aid, in addition to the special controls for a wireless hearing aid if the device incorporates wireless technology, are. (i) Clinical data must evaluate the effectiveness of the self-fitting strategy. (ii) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.

(iii) Software verification, validation, and hazard analysis must be performed. And (iv) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. Start Amendment Part17. In § 874.3315, revise paragraph (a) to read as follows.

End Amendment Part Tympanic membrane contact hearing aid. (a) Identification. A tympanic membrane contact hearing aid is a prescription wearable device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

A tympanic membrane contact hearing aid is subject to the requirements in § 801.422 of this chapter. * * * * * Start Printed Page 58191 [Removed] Start Amendment Part18. Remove § 874.3325. End Amendment Part Start Amendment Part19.

In § 874.3950, add a sentence at the end of paragraph (a) to read as follows. End Amendment Part Transcutaneous air conduction hearing aid system. (a) * * * A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter. * * * * * Start Signature Dated.

October 8, 2021. Janet Woodcock, Acting Commissioner of Food and Drugs. End Signature End Supplemental Information BILLING CODE 4164-01-PBILLING CODE 4164-01-PBILLING CODE 4164-01-C[FR Doc. 2021-22473 Filed 10-19-21.

Start Preamble Start Printed how much lasix cost Page 58150 http://hannahshands.org/what-do-you-need-to-buy-viagra/ Food and Drug Administration, HHS. Proposed rule. The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish how much lasix cost a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids.

Specifically, we propose to define OTC hearing aids and establish applicable requirements. Amend existing rules for consistency with a how much lasix cost new OTC category. Repeal the conditions for sale applicable to hearing aids.

Amend the existing labeling requirements for hearing aids. And update how much lasix cost regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids.

However, it would not change the how much lasix cost classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health. Submit either electronic or how much lasix cost written comments on the proposed rule by January 18, 2022.

Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021. You may submit comments as follows. Please note that late, untimely filed comments will not how much lasix cost be considered.

Electronic comments must be submitted on or before January 18, 2022. The https://www.regulations.gov electronic filing system will accept comments how much lasix cost until 11:59 p.m. Eastern Time at the end of January 18, 2022.

Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions how much lasix cost Submit electronic comments in the following way. • Federal eRulemaking Portal.

Https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.

Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions Submit written/paper submissions as follows. • Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the Docket No.

FDA-2021-N-0555 for “Establishing Over-the-Counter Hearing Aids.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.

You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at.

Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) at https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.

The title of this proposed collection is “Medical Device Labeling Regulations.” Start Further Info Srinivas Nandkumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, 301-796-5620, Srinivas.Nandkumar@fda.hhs.gov. With regard to the information collection. Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information Table of Contents Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Legal Authority Costs and Benefits Table of Abbreviations and Acronyms Commonly Used in This Document I. Background A. Need for the Regulation B.

Current Regulatory Framework for Hearing Aids C. History of This Rulemaking D. Incorporation by Reference II.

Legal Authority III. Description of the Proposed Rule A. Scope (Proposed § 800.30(a)) B.

Definitions (Proposed §§ 800.30(b) and 801.422(b)) C. Labeling (Proposed § 800.30(c)) D. Output Limits (Proposed § 800.30(d)) E.

Other Requirements (Proposed § 800.30(e) and (f)) F. Condition for Sale (Proposed § 800.30(g)) G. Preemption Provisions (Proposed § 800.30(h)) H.

Proposed Repeal of Conditions for Sale and Modifications for Prescription Labeling (§§ 801.420, 801.421, 801.422) I. Proposed Amendments to Previous Exemption Decisions (Part 808) J. Other Proposed Amendments IV.

Findings Regarding Premarket Notification V. Proposed Effective and Compliance Dates A. Effective Date B.

Compliance Date for Hearing Aids Not Legally Offered for Sale Prior to the Effective Date C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to the Effective Date VI. Preliminary Economic Analysis of Impacts VII.

Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X.

Consultation and Coordination With Indian Tribal Governments XI. References Executive Summary Purpose of the Proposed Rule Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention.

Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is proposing rules to address some of these concerns. Moreover, the FDA Reauthorization Act of 2017 (FDARA) directs FDA to establish a category of OTC hearing aids through rulemaking, and FDARA sets forth various requirements for OTC hearing aids, including preemption provisions.

In addition to protecting and promoting the public health, we have developed these proposed rules to establish the OTC category and implement the requirements of FDARA. Summary of the Major Provisions of the Proposed Rule FDA is proposing to establish a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids will be intended to address perceived mild to moderate hearing loss in people age 18 or older.

Alongside the OTC category, we are proposing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the eventual OTC category. We believe the proposals set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology. Among other things, FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls.

We are proposing general controls for OTC hearing aids consistent with FDARA. Moreover, because the FD&C Act specifies that OTC hearing aids are those that use the same fundamental scientific technology as air-conduction hearing aids, we would realign the existing classification regulations for hearing aids by sound conduction technology. However, the realignment would not affect the device class or premarket notification exemption status of any existing device.

On the effective date of the final rule, we would realign current product codes to correspond with the revised regulations for consistency but would not otherwise change the codes. This rulemaking also affects other existing regulations that apply to hearing aids. FDA has established device restrictions for hearing aids that include labeling requirements as well as conditions for sale.

We are proposing to remove these device restrictions for hearing aids, and establish a new regulation for prescription hearing aid labeling. Further, FDA has by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope.

We are proposing to remove the regulations codifying these decisions and establish other regulations clarifying some of the effects of statutory preemption under FDARA. Legal Authority The FD&C Act establishes a comprehensive system for the regulation of devices intended for human use. Hearing aids are devices intended for human use and so are subject to, among other requirements, the device provisions of the FD&C Act.

FDA has authority to establish regulatory controls needed to provide reasonable assurance of safety and effectiveness for these devices. As such, FDA is establishing regulatory controls for OTC hearing aids and amending regulatory controls for prescription hearing aids. Specific to OTC hearing aids, the FD&C Act and FDARA authorize multiple controls, including authority for FDA to establish requirements for device labeling, output limits, conditions for sale and distribution, and other requirements that provide reasonable assurance of safety and effectiveness of OTC hearing aids.

FDARA specifically directs FDA to establish a category of OTC hearing aids by regulation that must include the aforementioned requirements. More generally, the FD&C Act further provides for labeling requirements as general controls such that devices (and other medical products) will not be misbranded. The FD&C Act also authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.

We are proposing the following regulations pursuant to these authorities and to fulfill the directive under FDARA. Additionally, both the FD&C Act and FDARA include preemption provisions applicable to hearing aids. Costs and Benefits This proposed rule to establish OTC hearing aids and align other regulations, if finalized, would generate potential cost savings for consumers with perceived mild to moderate hearing loss who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online.

The proposed rule, if finalized, Start Printed Page 58152 would also generate costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule. We estimate benefits of between $6 million and $147 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $63 million per year. We estimate annualized costs of between $1 million and $2 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $1 million per year.

Combining benefits and costs, we used Monte Carlo analysis to estimate annualized net benefits of between $5 million and $145 million per year based on the 5th and 95th Monte Carlo percentile results with a mean of $62 million per year at both 3 percent and 7 percent discount rates. Table of Abbreviations and Acronyms Commonly Used in This DocumentAbbreviation/acronymWhat it means510(k)A premarket notification for certain devices.ANSIAmerican National Standards Institute.ASAAcoustical Society of America.CFRCode of Federal Regulations.CTAConsumer Technology Association.dBDecibel.dBAA-weighted decibel.EAEnvironmental assessment.FDAFood and Drug Administration.FD&C ActFederal Food, Drug, and Cosmetic Act.FDARAFDA Reauthorization Act of 2017.FONSIFinding of no significant impact.FRFederal Register.GMPsGood manufacturing practices.HzHertz.ISOInternational Organization for Standardization.MSWMunicipal solid waste.NASEMNational Academies of Sciences, Engineering, and Medicine.NIOSHNational Institute for Occupational Safety and Health.OMBOffice of Management and Budget.OSPL90Output sound pressure level with 90-dB input.OTCOver-the-counter.PCASTPresident's Council of Advisors on Science and Technology.PRIAPreliminary Regulatory Impact Analysis.PSAPPersonal sound amplification product.Pub. LPublic Law.QSQuality System.SPLSound pressure level.U.S.CUnited States Code.

I. Background FDA is proposing to define and establish general controls for an OTC category of hearing aids. We intend these proposals to provide for reasonable assurance of safety and effectiveness for these devices and improve access to and foster innovation in hearing aid technology for Americans, thereby promoting and protecting the public health.

We would make various other revisions, as described in this document, to align existing regulations with statutory requirements and the new OTC category. A. Need for the Regulation Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life (Refs.

1 and 2). Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention (Ref. 3).

The use of hearing aids has been linked to, among other health benefits, reductions in the incidence or severity of cognitive decline, depression, and other health problems in older adults (Ref. 3a and 3b). Additionally, benefits of hearing aid use can include improved social participation and a better quality of life.

Besides health benefits for individuals, more-widespread adoption of hearing aids could have broader effects. By increasing social participation, hearing aids could help to improve inclusion of individuals in family, economic, civic, and religious life. Thus, reducing barriers to hearing aid access might contribute to such improvements.

This could be particularly true for people of color, rural Americans, low-income individuals, and others for whom barriers to hearing aid access may be especially burdensome. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price) (Ref. 4).

In addition, stakeholders have cited Federal regulations that require specific labeling and conditions for sale, initially implemented in the late 1970s, as barriers to access ( e.g., Refs. 5 to 7). This document proposes a number of changes to the regulatory framework for hearing aids to remove or reduce barriers to certain air-conduction hearing aids for perceived mild to moderate hearing impairment—a type of impairment often associated with aging—that have the potential to be of great benefit to the public health.

These proposals follow the enactment of FDARA, which included provisions directing FDA to establish regulatory requirements for a new category of OTC hearing aids and amended the FD&C Act to add section 520(q) (21 U.S.C. 360j(q). See Pub.

L. 115-52). Section 520(q)(1) of the FD&C Act defines OTC hearing aids, in part, as devices available over-the-counter, without the supervision, Start Printed Page 58153 prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

Section 520(q)(2) of the FD&C Act requires that such devices be subject to the regulations FDA issues for them in accordance with section 709(b) of FDARA. Section 709(b) of FDARA requires that FDA establish a category of OTC hearing aids that includes, among other elements, requirements to provide reasonable assurances of the safety and effectiveness of these devices. We also make multiple proposals to prevent the sale of OTC hearing aids to or for people younger than age 18.

This document does not, however, propose to create or classify a new device type.[] Further, this document does not propose to exempt additional devices from the premarket notification requirements under section 510(k) of the FD&C Act, commonly referred to as “a 510(k)” (21 U.S.C. 360(k)). Section IV of this document discusses our findings regarding premarket notification in more detail.

We are simultaneously proposing related changes to the regulatory framework that currently applies to all hearing aids, as they are defined in § 801.420 (21 CFR 801.420), in light of the new OTC category and to ensure consistency across rules pertaining to hearing aids (see § 801.420(a)(1)). Detailed information about each proposal appears in section III. B.

Current Regulatory Framework for Hearing Aids Hearing aids, as defined in § 801.420(a)(1), are currently restricted class I and class II devices of multiple types. A summary of the current regulatory framework for these devices appears in table 1. Table 1—Summary of Current Regulatory FrameworkClassification regulation, 21 CFR section874.3300874.3305874.3315874.3325874.3950Device RestrictionsRestrictedRestrictedRestrictedRestrictedRestricted.Class I, 510(k) exempt 1Air-conduction (“legacy”)Class II, 510(k) exempt 1Wireless air-conductionClass IIBone-conductionTympanic membrane contact hearing aidSelf-fitting air-conductionTranscutaneous air-conduction hearing aid system.Product codesESD, LXB, MAH, LRB, LDGOSMPLKQDDNIX.1  510(k) exemptions are subject to the limitations in 21 CFR 874.9.

1. Hearing Aid Classifications Hearing aids are class I and class II wearable sound-amplifying devices intended to compensate for impaired hearing. They currently fall under five classification regulations (the following references are to sections in Title 21 of the CFR).

a. Hearing aid (§ 874.3300 (21 CFR 874.3300)). This device type includes air-conduction (class I, 510(k) exempt, subject to the limitations of exemption in § 874.9) and bone-conduction (class II) hearing aids.

Class II bone-conduction hearing aids require a 510(k) notification. These are all restricted devices. b.

Wireless air-conduction hearing aid (§ 874.3305 (21 CFR 874.3305)). This device type is a hearing aid that incorporates wireless technology in its programming or use, for example, controls over Bluetooth. These devices are class II restricted, subject to the special controls that have been issued for these devices, and 510(k) exempt, subject to the limitations of exemption in § 874.9.

c. Tympanic membrane contact hearing aid (§ 874.3315 (21 CFR 874.3315)). This device type is a prescription device that compensates for impaired hearing.

Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. d.

Self-fitting air-conduction hearing aids (§ 874.3325 (21 CFR 874.3325)). This device type is a hearing aid that incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fittings and settings.

These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. e. Transcutaneous air conduction hearing aid system (§ 874.3950 (21 CFR 874.3950)).

This device type consists of an air-conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. These devices are class II restricted, subject to the special controls that have been issued for these devices, and require a 510(k) notification. Devices of these types may be either prescription (for example, devices for insertion deep in the ear canal) or non-prescription devices (which include the majority of air-conduction hearing aids).[] For the purposes of this rulemaking, we refer to non-wireless, non-self-fitting, air-conduction hearing aids as “legacy hearing aids,” which means all air-conduction hearing aids currently within § 874.3300 but not air-conduction hearing aids currently within §§ 874.3305, 874.3325, or 874.3950.

Start Printed Page 58154 2. Hearing Aid Restrictions Hearing aids are currently subject to a set of restrictions on sale, distribution, and use, established in accordance with section 520(e) of the FD&C Act. We will refer to those as “Hearing Aid Restrictions,” and they include requirements for professional and patient labeling, as a well as conditions for sale (see §§ 801.420 and 801.421 (21 CFR 801.420 and 801.421, respectively)).

All legacy hearing aids, wireless air-conduction hearing aids, and self-fitting hearing aids (as well as other device types) fall within a separate, broader definition of hearing aids in § 801.420(a)(1), and therefore are currently subject to these restrictions. Among other requirements, § 801.420 specifies that the User Instructional Brochure labeling for hearing aids contain a warning statement for hearing aid dispensers that prompts them to advise prospective purchasers to consult with a physician if any of the listed medical conditions are present (see § 801.420(c)(2)). We will refer to these medical conditions as “red flag” conditions in this proposal.

The rule further prescribes a notice to prospective users and an additional statement about hearing loss in children (see § 801.420(c)(3)). It also requires the disclosure of technical data useful in selecting, fitting, and checking the performance of hearing aids (see § 801.420(c)(4)). Currently, § 801.421 specifies a number of conditions for sale for hearing aids.

Such conditions include that a prospective user must present to the dispenser a signed statement of medical evaluation from a physician prior to sale (see § 801.421(a)(1)). However, a prospective user who is 18 years of age or older may waive the medical evaluation requirement by signing a statement with a prescribed advisement (see § 801.421(a)(2)). A dispenser must provide an opportunity for the prospective user to review the User Instructional Brochure prior to signing a waiver and the sale of a hearing aid (see § 801.421(b)).

Manufacturers and distributors must provide sufficient copies of User Instructional Brochures to dispensers, and upon written request, to prospective users. Dispensers must similarly provide the brochures (or the name and address of a manufacturer or distributor to obtain a brochure) to prospective users upon request (see § 801.421(c)). Dispensers generally must retain a copy of a medical evaluation statement or signed waiver for 3 years (see § 801.421(d)).

However, we announced in a guidance entitled “Conditions for Sale for Air-Conduction Hearing Aids” that we do not intend to enforce the medical evaluation, waiver, or recordkeeping requirements of § 801.421 with respect to prospective purchasers who are 18 or older (Ref. 8). In addition to other applicable misbranding and adulteration provisions in sections 501 and 502 of the FD&C Act (21 U.S.C.

351 and 21 U.S.C. 352, respectively), hearing aids are currently subject to misbranding provisions for restricted devices under section 502(q) and (r) of the FD&C Act. Section 704(a) of the FD&C Act (21 U.S.C.

374(a)) authorizes FDA to inspect, among other things, certain records relating to restricted devices. 3. State Requirements for Hearing Aids Under certain circumstances, State requirements apply to hearing aids notwithstanding Federal requirements.

In general, FDA's regulation of hearing aids preempts State law, meaning that a State or a political subdivision ( e.g., a city) may not establish or continue in effect its own requirement if that requirement is “different from, or in addition to,” a requirement under the FD&C Act (see section 521(a) (21 U.S.C. 360k(a))). Many States have established requirements equivalent to § 801.420 or § 801.421 ( i.e., not “different from, or in addition to” those regulations), which are not preempted by these Federal requirements.

However, for other State requirements, FDA has granted and denied exemptions from preemption under section 521(b) of the FD&C Act for some States that have applied. FDA responds to applications for such exemptions by regulation, codified in subpart C of part 808 (21 CFR part 808). Most of these regulations relate to hearing aids, and in some of these regulations, FDA has granted exemptions—meaning those States' requirements apply instead of, or in addition to, FDA's requirements—for.

Specifying the physician expertise needed to examine prospective purchasers who are younger than 18 years of age. Advising purchasers when to seek medical attention based on “red flag” conditions. Providing purchasers with certain information and disclosures on receipts and other documentation.

Recordkeeping requirements in addition to the Hearing Aid Restrictions. And Providing written notice of a money-back guarantee where a State court held the State requirement was preempted. And FDA has denied exemptions—meaning the States could not establish or continue in effect requirements—for.

Removing the waiver option for prospective purchasers who are 18 years of age or older. Lowering the age at which a waiver of medical examination prior to purchase was available. Changing the expertise for examinations, when conducted, for people 18 years of age and older.

Prohibiting certain marketing claims about improving hearing. And Adopting different device testing standards. FDARA added a separate Federal preemption provision for State and local laws, regulations, orders, or other requirements (for brevity, we will refer to “State or local requirements” in this rulemaking) specifically related to hearing products (FDARA section 709(b)(4)).[] That provision may affect the applicability of State or local requirements for OTC hearing aids.

Section III.G discusses the OTC hearing aid preemption provisions and the effects of this rulemaking. 4. Hearing Products Not Regulated as Hearing Aids FDA does not consider personal sound amplification products (PSAPs) to be “devices” within the meaning of section 201(h) of the FD&C Act (21 U.S.C.

321(h)) when they are not intended to aid a person with, or compensate for, impaired hearing and do not otherwise meet the device definition. Such PSAPs are not subject to medical device regulations, nor would the proposed requirements of this rulemaking apply to such PSAPs.[] Note that the name of a product on its own would not ordinarily demonstrate intended use. Thus, merely calling a product something besides “hearing aid” would not remove a product from device regulation under the FD&C Act if, for example, its labeling demonstrated that the product was intended to compensate for hearing loss.

C. History of This Rulemaking Although this proposal is the first step in this rulemaking, FDA has taken other steps to initiate an update of the regulatory framework for hearing aids. Start Printed Page 58155 Prior to the enactment of FDARA, FDA had considered means to improve access to hearing aids.

For example, we considered a report on the public health implications of hearing loss in adults that made recommendations to improve affordability and accessibility of hearing aids and to foster innovative hearing aid technology. The October 2015 report by the President's Council of Advisors on Science and Technology (PCAST) recommended, among other actions, that, “FDA should approve [a] class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser” (Ref. 7).

In addition, the report concluded, among other things, that the Federal requirement for a medical examination, or a written waiver of such examination, “provides little patient benefit, while acting as a barrier to access for the millions of Americans needing hearing assistance” (Ref. 7). Similarly, FDA, other Federal Agencies, and a consumer advocacy group co-sponsored a study entitled “Hearing Health Care for Adults.

Priorities for Improving Access and Affordability” through the National Academies of Sciences, Engineering, and Medicine (NASEM). The resulting NASEM report, published on June 2, 2016, similarly recommends that FDA create a new category of OTC “wearable hearing devices” (using a term distinct from “hearing aids”) and also that FDA remove the medical evaluation requirement for adults for hearing aids (Ref. 6).

After a review of the literature and relevant clinical databases from the U.S. Department of Defense and the U.S. Department of Veterans Affairs, NASEM concluded that the health risk of missed diagnosis of treatable causes of hearing loss in adults is low, and “[the] regulation [requiring a medical examination or waiver] provides no clinically meaningful benefit, and the waiver presents a barrier to access with no substantial enhancement of patient safety.” Both PCAST and NASEM provided recommendations regarding FDA Quality System requirements (which set forth requirements for good manufacturing practices or GMPs) for the proposed category of OTC hearing aids.

PCAST stated the following. FDA should exempt this class of hearing aids from QSR regulation in its present form and substitute compliance with standards for product quality and recordkeeping appropriate for the consumer-electronics industry, developed by an appropriate third-party organization and approved by FDA. Similar actions should be taken with respect to diagnostic hearing tests used to dispense and fit Class I hearing aids.

However, NASEM recommended that these devices “[b]e subject to quality system regulation (QSR) requirements, but be considered for exemption from certain QSR requirements as determined by FDA to be appropriate for this category.” We held a public workshop on April 21, 2016, entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids,” (announced at 81 FR 784. See Ref. 9 for materials).

FDA requested comments on several topics relating to hearing healthcare technology and improved access, including the appropriate level of GMP regulation (Quality System requirements) to ensure the safety and effectiveness of air-conduction hearing aid devices in consideration of the PCAST report recommendations. FDA received hundreds of comments to the docket for this workshop prior to the (extended) deadline of June 30, 2016. In addition, 2 keynote speakers (from PCAST and NASEM), 12 invited speakers, and 24 public speakers offered comments or presentations at the workshop.

Workshop speakers and submitters of docket comments were generally. Healthcare professionals (or healthcare professional organizations), members of industry, patients or consumers, academics, consensus standards developers, and science organizations. Comments from this workshop ranged generally from strong opposition to strong support for the PCAST recommendations.

Other comments were more nuanced. To summarize very broadly, all parties agreed that some combination of regulatory requirements and flexibility in compliance would provide reasonable assurance of safety and effectiveness. The differences in opinion lie in the preferred approach and its implementation to achieve these common goals.

For example, some preferred amending the QS regulation and relying on inspections while others preferred allowing voluntary conformity to a consensus standard potentially relying on third-party certification. In another effort to address the current regulatory framework, FDA also issued a guidance document, as noted above, related to the conditions for sale for air-conduction hearing aids. In that document, we announced our intent to reexamine and modify § 801.421 based on the PCAST and NASEM recommendations, as well as from other stakeholders, taking into consideration and addressing their recommendations as appropriate before adopting regulations for OTC hearing aids.

The docket no. FDA-2016-D-3466 included commentary that expressed support for the creation of a “basic” category of hearing aids such as OTC hearing aids and provided recommendations for measures to support safe and effective use. We also received multiple telephone calls expressing similar interest in reducing regulatory burdens and questioning how the issuance of the guidance affected States' requirements.

In developing this proposed rule, we considered the input and questions we have received on the guidance, as well as the comments from the April 2016 public workshop and the recommendations from PCAST and NASEM. D. Incorporation by Reference FDA is proposing to incorporate by reference the Method and tables for clause 4.1 of ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” dated January 2017, from the American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036.

Https://www.ansi.org, 202-293-8020. You may download the standard from the web at https://webstore.ansi.org/​standards/​ansi/​cta20512017ansi. The Method and tables for clause 4.1 describe how to measure frequency response and include technical data for adaptations for different circumstances.

The Method and tables would provide a standardized way to quantify frequency response for OTC hearing aids and meet the related proposed requirements (see section III.E.1). FDA is also proposing to incorporate by reference ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” dated November 2014, from the American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036. Https://www.ansi.org, 202-293-8020.

ANSI/ASA S3.22-2014 describes tolerances and test methods used for certain measurements of hearing aid performance. The application of ANSI/ASA S3.22-2014 provides professional hearing aid fitters with standardized technical information to help them select the correct hearing aid and ensure optimal fit and performance for hearing aid users (see section III.H.2). II.

Legal Authority The FD&C Act establishes a comprehensive system for the regulation of devices, as defined in section 201(h) of the FD&C Act, intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) defines three classes of devices, reflecting the regulatory Start Printed Page 58156 controls needed to provide reasonable assurance of their safety and effectiveness.

The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for human use and are subject to the FD&C Act.

Currently, air-conduction hearing aids are generally either class I or class II devices. FDARA amended the FD&C Act to apply requirements specific to certain hearing aids and defined the term “over-the-counter hearing aid” (see 21 U.S.C. 360j(q)).

We are issuing these requirements for OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes FDA to establish requirements for labeling, output limits, conditions for sale and distribution of OTC hearing aids, and other requirements that provide for reasonable assurance of safety and effectiveness of these devices. In addition, the FD&C Act provides that a device is misbranded unless, among other requirements, its labeling bears adequate directions for use (see section 502(f)(1) of the FD&C Act). Consistent with section 502 of the FD&C Act, FDA has issued regulations that exempt certain kinds of devices from the requirement for adequate directions for use.

Section 502(f)(2) further requires adequate warnings against use of a device in those pathological conditions, or by children, where use of the device may be dangerous to health. The labeling must also bear adequate warnings against unsafe dosage or methods or duration of administration or application (see section 502(f)(2) of the FD&C Act). Such warnings must be in such manner and form as are necessary for the protection of the users (see section 502(f)(2) of the FD&C Act).

A device is also misbranded if its labeling is false or misleading in any particular (see section 502(a) of the FD&C Act). Section 201(n) of the FD&C Act states that in determining whether labeling or advertising is misleading, there shall be taken into account not only representations made or suggested but also the extent to which labeling or advertising fails to reveal material facts. Other misbranding provisions under the FD&C Act would apply as well, including section 502(c), which deems a device to be misbranded if any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Additionally, section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act (21 U.S.C. 371(a)). The proposals in this rulemaking would be for the efficient enforcement of the FD&C Act because, if finalized, they will provide standards for the legal marketing of safe and effective hearing aid devices.

Violations of any final rules from this rulemaking, once in effect, would render the hearing aids adulterated and/or misbranded under sections 501 and/or 502 of the FD&C Act, and subject to enforcement action, for example, seizure (see section 304 of the FD&C Act (21 U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C. 332)), and criminal prosecution (see section 303 of the FD&C Act (21 U.S.C.

333)). Prohibited acts include, among others, introducing an adulterated or misbranded device into interstate commerce (see section 301 of the FD&C Act (21 U.S.C. 331)).

Under section 521 of the FD&C Act, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement that is different from, or in addition to, any requirement applicable under the FD&C Act to the device and that relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C Act also provides that FDA may grant an exemption from preemption under certain circumstances.

Section 709(b) of FDARA also includes a preemption provision with respect to requirements for OTC hearing aids. III. Description of the Proposed Rule We are proposing multiple related actions in this rulemaking.

Add to part 800, subpart B (21 CFR part 800, subpart B), definitions and other rules for OTC hearing aids. Remove § 801.420 and repeal § 801.421. Add to part 801, subpart H (21 CFR part 801, subpart H), § 801.422, labeling requirements for prescription hearing aids.

Amend part 874, subpart D (21 CFR part 874, subpart D), in multiple places to update classification regulations for hearing aids and align hearing aid types by sound-conduction technology. And Amend part 808, subparts A and C (21 CFR part 808, subparts A and C), by updating the Scope and removing most of the current regulations codifying previous decisions for exemption from Federal preemption for certain States. If this action is finalized, all non-OTC hearing aids will be prescription devices and would be subject to the labeling requirements in new § 801.422 as well as those in the existing § 801.109, but they would no longer be restricted devices.

Note that a prescriber is any practitioner licensed by the law of the State in which the practitioner practices to use, or order the use of, the device. When the prescriber of a hearing aid need not be a physician, the labeling of a prescription hearing aid will describe other prescribers, for example, audiologists (see § 801.109(b)(1)). We believe the proposed actions will, in combination, promote and protect the public health by, among other things, providing reasonable assurance of safety and effectiveness of OTC and prescription hearing aids.

These actions would also help minimize the complexity of the applicable regulations, if finalized, through organization. We are proposing to add the OTC Hearing Aid Controls to 21 CFR part 800, subpart B, entitled “Requirements for Specific Medical Devices,” which would make them easy to locate. Labeling requirements for prescription devices would remain in part 801, Labeling, subpart H, “Special Requirements for Specific Devices.” Table 2 outlines the proposed hearing aid rules.

Section III.I summarizes the proposed revisions to part 808. Table 2—Outline of Proposed Hearing Aid Rule800.30801.422874.3301874.3305Over-the-counter hearing aid controls 1Prescription hearing aid labeling 1Bone-conduction hearing aidAir-conduction hearing aid(a) Scope.(a) Scope.(a) Identification.(a) Identification.(b) Definitions.(b) Definitions.(b) Classification.(b) Classification.Start Printed Page 58157(c) Labeling.(c) Labeling.Product codes LXB, MAH. • Legacy. • Package. • Package. • Wireless. • Labeling Inside the Package. • Labeling Inside the Package. • Self-Fitting. • Labeling on the Device. • Labeling on the Device.Product codes ESD, OSM, QDD, • Technical Specifications. • Technical Specifications. LRB, and LDG.  • Misbranding.(d) Output Limits.(d) Incorporation by Reference.(e) Electroacoustic Performance. • Distortion Control. • Self-generated Noise. • Latency. • Bandwidth. • Smoothness.(f) Design Requirements. • Insertion Depth. • Atraumatic Materials. • Proper Fit. • Tools, Tests, or Software.(g) Condition for Sale.(h) Effect on State Law.(i) Incorporation by Reference.1  These requirements would apply in addition to all other applicable requirements, including applicable labeling requirements in parts 801 and 830 (21 CFR parts 801 and 830). For example, for prescription devices, the labeling requirements in § 801.109 would continue to apply in addition to new § 801.422.

A. Scope (Proposed § 800.30(a)) The regulation would clarify which devices are subject to the OTC Hearing Aid Controls. Among other changes, FDARA amended the FD&C Act to define the term “over-the-counter hearing aid,” and section 709 of FDARA directs FDA to establish certain requirements for labeling, output limits, conditions for sale, and other requirements that provide reasonable assurances of the safety and effectiveness of OTC hearing aids.

We propose to call this set of requirements “Over-the-Counter Hearing Aid Controls” and add § 800.30 to establish the OTC category of hearing aids and their requirements. The scope, proposed paragraph (a), would specify the devices to which the regulation would apply, assisting with the determination of applicable requirements. This provision clarifies that a hearing aid is either in the prescription or OTC category and that, regardless of category, special controls found in the applicable classification regulation and other requirements in the FD&C Act apply.

B. Definitions (Proposed §§ 800.30(b) and 801.422(b)) FDA proposes to include the definition of an OTC hearing aid, consistent with the definition in section 520(q)(1) of the FD&C Act, and the definitions of other terms integral to understanding § 800.30. In several cases, we are proposing parallel definitions (sometimes slightly modified) under the proposed requirements for prescription hearing aid labeling in § 801.422.

Defining hearing aids. FDARA authorizes controls for devices that, among other characteristics, use the same fundamental scientific technology as air-conduction hearing aids under §§ 874.3300 or 874.3305. Section 520(q)(1)(A)(i) of the FD&C Act does not specifically refer to § 874.3325 because, at the time of FDARA's enactment, FDA had not classified that device type.

However, we consider self-fitting hearing aids currently classified under § 874.3325 to be eligible for regulation as OTC hearing aids. We consider them as such because, although self-fitting hearing aids under § 874.3325 differ from hearing aids under §§ 874.3300 and 874.3305 in that they incorporate technology, including software, that allows users to program their hearing aids, self-fitting hearing aids use the same air-conduction technology as hearing aids under §§ 874.3300 and 874.3305. Self-fitting hearing aids also meet the other elements of the OTC hearing aid definition in section 520(q)(1)(A) of the FD&C Act.

For example, self-fitting hearing aids, through tools, tests, or software, allow the user to control the hearing aid and customize it to the user's hearing needs (see section 520(q)(1)(A)(iii) of the FD&C Act). The proposed definitions of “hearing aid” (which is the current definition), “air-conduction hearing aid,” “over-the-counter hearing aid,” and “prescription hearing aid” help to delineate the different device categories.[] As stated in section 520(q)(1)(B) of the FD&C Act, the definition of “over-the-counter hearing aid” does not include PSAPs. Similarly, the definition of “hearing aid” more generally excludes PSAPs that are not intended to aid with or compensate for impaired hearing.

The proposed definition of “prescription hearing aid” in proposed § 801.422 is the same as that in the OTC Hearing Aid Controls except that the definition for prescription devices would cross-reference the OTC Hearing Aid Controls, proposed § 800.30. Defining licensed persons. In that vein, OTC hearing aids will be available without the supervision, prescription, or other order, involvement, or intervention of a licensed person (section 520(q)(1)(A)(v) of the FD&C Act).

A definition of “licensed person” would help delineate that a patient or consumer of OTC hearing aids will not need to consult an audiologist, a physician, or other licensed person prior to or after purchasing an OTC Start Printed Page 58158 hearing aid. The proposed definition of “licensed person” also clarifies that FDA interprets “licensed person” to include businesses consistent with the broad definition of “person” in section 201(e) of the FD&C Act. For example, OTC hearing aids may be available for sale from businesses that are not specially licensed to distribute OTC hearing aids.[] FDA does not interpret section 520(q)(1)(A)(v) of the FD&C Act or section 709(b) of FDARA as preempting a State's ability to establish or continue in effect generally applicable State business or professional licensing requirements.

In general, such requirements would not be “specifically related to hearing products,” so they are not subject to section 709(b)(4) of FDARA. If a person purports to be a licensed professional or business, then a State could regulate the person as such. Thus, for example, a person identifying as an “audiologist” would be subject to State professional or facility licensure requirements because an audiologist is a licensed professional.

However, unlike identifying as an “audiologist,” some descriptions for professions do not on their own imply licensure in relation to OTC hearing aids. Section 709(b)(4) of FDARA lists certain activities that may be undertaken with respect to OTC hearing aids without the supervision, prescription, or other order, involvement or intervention of a licensed person. FDARA specifically lists the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids.

(For convenience, we will refer to these activities collectively as “commercial activity” in this document.) Thus, a person representing as a marketer, seller, dispenser, distributor, or customer support representative (or an equivalent description) of OTC hearing aids would not be a “licensed person” for the purposes of § 800.30 solely for that reason. Nor could a State require such persons to undertake special licensing or equivalent activities. In contrast, a person voluntarily identifying, for example, as a “licensed dispenser” ( i.e., not just a “dispenser”) would be subject to corresponding State requirements for such dispensers to the extent that the State requirements do not restrict or interfere with commercial activity involving OTC hearing aids (see section 709(b)(4) of FDARA).

The proposed definition of “licensed person” specifies the descriptions of profession, consistent with section 709(b)(4) of FDARA, that would not, on their own, imply licensure relating to OTC hearing aids. Section III.G of this document describes other preemption scenarios in addition to licensed persons. Defining tools, tests, or software.

Another element of the definition of OTC hearing aids requires that users be able to control or customize the devices through tools, tests, or software (see section 520(q)(1)(A)(iii) of the FD&C Act). We interpret this requirement to refer to the ability for a layperson to perform such activities. As such, the proposed definition of “tools, tests, or software” clarifies that OTC hearing aids are those devices that allow lay users to control the device and customize it, such as the device's output, to meet their individual hearing needs.

Other definitions. The proposed definition of “used hearing aid” in both the OTC and prescription device provisions clarifies which hearing aids would be subject to certain proposed labeling requirements for used or rebuilt hearing aids. The proposed definitions are the same for OTC and prescription hearing aids, and they are derived from the current definition in § 801.420 except that we have revised the wording for clarity.

The proposal for prescription hearing aid labeling in § 801.422 retains the definition for “dispenser” that is currently applicable to all hearing aids. However, we propose to revise the wording to clarify that the definition applies only for purposes of prescription hearing aid labeling and propose other clarifying revisions to track the definition of “person” in section 201(e) of the FD&C Act more closely. We believe the definition will continue to be useful because the proposed requirements for prescription hearing aids refer to the dispenser.

FDA welcomes comments on the definitions pertinent to the regulation of OTC hearing aids (as well as any other portion of this proposal). In particular, we seek comments on the clarity of the definitions and ways to improve the definitions to encourage and support the broad availability of safe and effective devices. C.

Labeling (Proposed § 800.30(c)) We are proposing labeling requirements to provide consumers with essential information for the safe and effective use of OTC hearing aids. Section 709(b)(2)(C) of FDARA specifically directs FDA to include, among appropriate labeling requirements, a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed healthcare practitioner. In addition, section 709(b)(2)(A) of FDARA directs FDA to establish requirements that provide reasonable assurances of the safety and effectiveness of OTC hearing aids, and we intend the proposed labeling requirements to do so.

In considering which statements to require, we note the important role of information in supporting broader use of OTC hearing aids. As part of the 2016 FDA hearing aid workshop, the Hearing Loss Association of America presentation stressed the importance of clear labeling to inform consumers so that the consumer “is empowered and knows what they're buying and knows the limitations and what's possible” (Refs. 9 and 10).

FDA agrees, and we have proposed labeling requirements to empower consumers. Further the proposed conspicuous statement that OTC hearing aids are intended for people age 18 years and older is necessary because the use of OTC hearing aids in people younger than 18 presents risks to health beyond those typically associated with use in older people. Whereas hearing loss in older adults is most commonly related to noise exposure and aging, the etiology (causes) of hearing loss in younger people is varied and may result from conditions that warrant prompt diagnosis to avoid serious risks to health.

These conditions may not be readily apparent and can include, but are not limited to. Congenital malformations (present since birth) of the external, middle, or inner ear. s, for example, otitis media (an inflammation of the middle ear) or congenital s.

Genetic causes, including hereditary syndromes that can involve cardiac, ophthalmic, renal, neurologic, and other organ systems (that is, syndromes that can involve the heart, eyes, kidneys, nerves, and other organs). Or Certain exposures, for example, lead poisoning, hyperbilirubinemia (a buildup of a metabolic byproduct, bilirubin, in the blood), and drug ototoxicity (a toxic effect on the ear or its nerves). The use of a hearing aid to treat hearing loss related to these conditions, without a medical evaluation, may delay diagnosis and treatment of the Start Printed Page 58159 underlying condition.

Further, prompt diagnosis is critical because, left untreated, these conditions may worsen, with potentially lifelong, adverse health effects. Because the use of OTC hearing aids in people younger than 18 presents risks to health beyond those typically associated with use in older people, the proposed conspicuous statements are appropriate and provide reasonable assurance of safety and effectiveness of OTC hearing aids. The proposed labeling provisions include requirements for labeling on the package and inside the package, along with requirements for labeling on the device itself.

These requirements would apply in addition to all other applicable labeling requirements in, for example, parts 801 and 830. In any of the labeling, manufacturers could continue to include additional truthful, non-misleading information provided it does not conflict with other requirements (such as those mentioned above). In proposing where to place labeling statements—on the package or inside the package—we have considered when users, prospective users, and others should become aware of information (before or after purchase).

We have also considered the limited space available on the packaging as well as simplicity of format. FDA welcomes your comments on the proposed labeling requirements, including the placement or conspicuousness of statements, as well as whether the statements are clear and understandable. For example, in reviewing the proposals, did you find important information quickly?.

Did you find the information clear and easy to understand?. We are particularly interested in your feedback about phrasing or formatting to convey information to people who are anticipated users, or more generally, who are not hearing health professionals. A rationale or evidence would make your feedback more useful.

For example, if a proposed statement is unclear, telling us why is generally more helpful than saying only that you find the statement to be unclear. 1. Package Labeling We are proposing that the outside of the package include information that consumers would need to know prior to purchasing the device, such as who is a candidate for the device, how to determine if you are a candidate, and when to seek professional help before trying the device.

We believe this information empowers consumers and answers threshold questions about the suitability of purchasing an OTC hearing aid for their hearing needs. This proposal would also emphasize who the intended user is, to reduce the likelihood that people younger than 18 would purchase or use an OTC hearing aid. To summarize, the proposed statements on the package describe.

A conspicuous warning that the device is not for users younger than 18 years old. The symptoms of perceived mild-to-moderate hearing loss. Considerations for seeking a consultation with a hearing healthcare professional.

And Red flag conditions. Warnings to consumers regarding signs and symptoms that should prompt a consultation with a licensed physician (preferably an ear specialist). However, we are not proposing to require other information on the package, for example, mobile operating system compatibility or whether the package contains the necessary batteries.

Further, we are proposing language that accurately conveys information to readers without relying on specialized knowledge ( i.e., for laypeople). We welcome your comments on whether to require other information on the package labeling and whether you had any difficulty understanding the information (and if so, your suggestions for improvements). a.

Symptoms suggesting perceived mild to moderate hearing loss. Prospective users may not know their definitive degree, configuration, or etiology of hearing loss. That is, they may not know the exact nature or cause, so commenters for the public meeting discussed various ways to communicate the signs of perceived mild to moderate hearing loss and reasons to seek medical evaluation.

They generally agreed that such information should appear on the outside of the package. We agree with this sentiment and are proposing that the information be readily apparent prior to purchase to help people to determine whether an OTC hearing aid may benefit them. To that end, we are proposing four scenarios that a person may recognize (symptoms) that suggest perceived mild to moderate hearing loss.

We have selected these scenarios because they commonly present difficulties to people with perceived mild to moderate hearing loss and are situations in which users are likely to benefit from the use of OTC hearing aids. We have also based the selection on stakeholder input from the public workshops. Although people with normal hearing may sometimes experience these scenarios, people with perceived mild to moderate hearing loss will experience them more frequently, if not regularly.

We have phrased the information to emphasize that the device is intended for people who are 18 or older, and the phrasing avoids medical and technical terms while describing everyday situations. b. Considerations for seeking consultation with a hearing healthcare professional.

However, because a prospective user may have hearing impairment beyond, or different from, perceived mild to moderate hearing loss, we are proposing a statement to assist people in evaluating the potential for increased benefit from an OTC hearing aid. We believe this information is important, and have titled it as such, and appropriate for users and prospective users who are not familiar with hearing aids. c.

€œRed flag” conditions. In that vein, we are proposing to continue to require a statement advising users and prospective users to seek medical care if they exhibit any one of a number of conditions. We are not modifying the list of conditions from its present form except for phrasing and formatting changes to improve readability, as well as a change to the time periods (from 90 days to 6 months).

We intend the change to the time periods to encourage consumers to consider a longer personal history, which may help them to identify the conditions without the involvement of a licensed person. The list includes reliable indicators of the possibility of an underlying medical condition that a hearing aid cannot treat. For example, fluid, pus, or blood coming out of the ear may indicate an active , as could sudden, quickly worsening, or fluctuating hearing loss.

An examination by a physician, preferably an ear specialist, would determine whether such an underlying condition is present and treatable, potentially halting or reversing hearing loss. d. Other information.

We are also proposing to require that the outside package include a web address and telephone number for consumers to access a digital copy or request a paper copy of all labeling, including the labeling inside the package, for that OTC hearing aid. A website could provide easy access to the more comprehensive information found in the labeling inside the package and could allow the use of other media to convey information. FDA is proposing to require that this labeling be available online or be able to be requested by phone prior to purchase to facilitate product familiarity to make a purchasing decision.

We believe having the information found inside the package will help prospective users Start Printed Page 58160 choose a safe and effective device without the involvement of a licensed person. As proposed, this information would be available without the need for consumers to register for access, for example, by registering for a website member login. Further, a download page could include, but would not be required to include, additional resources, for example, video explanations or tutorials to aid prospective users in selecting and using a device, as well as a mechanism for reporting complaints or adverse events.

Since such additional resources would not be required under this proposal, accessing such resources could entail, for example, registering as a website member. Please note that we are not proposing to require the distribution of paper copies for all OTC hearing aids because an analogous provision in the Hearing Aid Restrictions yielded little benefit—very few people requested a review of the paper copy—while adding to the regulatory burden. We are seeking comment on these proposed requirements (and any other portion of this proposed rule) regarding equitable access to the information and/or OTC hearing aids.

We are also proposing to require that the manufacturer disclose its return policy or, if none, state that it does not accept returns. Such a requirement would be appropriate, because prospective users of OTC hearing aids may be unsure whether an OTC hearing aid will meet their hearing needs. If an OTC hearing aid does not meet a user's hearing needs, the user may leave the device in the “dresser drawer.” (This is a common description of the phenomenon of relegating the device to disuse—putting it away, never to use it again—and foregoing the potential benefit of a more-satisfactory device).

Thus, a statement of the return policy would be appropriate because, without the services of a licensed person, some users may be more dependent on the manufacturer's return policy (as opposed to the licensed person's) to avoid leaving an OTC hearing aid in the dresser drawer. A statement of the return policy would provide appropriate information to prospective users to help them determine the suitability of options given individual circumstances and preferences such as budget and willingness to try multiple OTC hearing aids. Additionally, consistent with the existing hearing aid requirement in § 801.420(c)(5), we are proposing that, when an OTC hearing aid is used or rebuilt, the outside package declare that fact.

These requirements would advance the public health by facilitating the purchase of devices that meet users' hearing needs. We are not proposing to require that manufacturers accept returns under these proposed Federal regulations. However, we likely would not consider a generally applicable State or local requirement to accept returns ( i.e., the requirement applies to any product) as a requirement specifically related to hearing products.

Further, we believe that a State or local requirement for retailers (persons who sell to end users) to accept returned OTC hearing aids would likely promote—rather than restrict or interfere with—commercial activity involving the devices by reducing the financial risk to purchasers. As such, generally, State or local requirements for returns would continue to apply provided they do not conflict with the final rule based on this rulemaking. We are seeking comment on whether such a State or local requirement would promote, rather than restrict or interfere with, commercial activities involving OTC hearing aids.

Participants at the June 9, 2017, NASEM public workshop generally agreed with the importance and utility of requiring certain information on the package. Participants discussed potential labeling requirements such as these for OTC hearing aids (see Ref. 11).

Numerous participants focused on the signs and symptoms of consumers who have mild-to-moderate hearing loss and might potentially benefit from OTC hearing aids. Specifically, participants expressed concerns that consumers would need information to help decide whether to purchase the products and/or whether to seek professional services. The proposed requirements in this document have taken these comments into account.

2. Labeling Inside the Package We are proposing to require that manufacturers place labeling inside of the package with the information that consumers will need after purchasing an OTC hearing aid for its safe and effective use. The proposed content of this labeling includes.

Warnings, cautions, and notes, including a conspicuous statement warning against the use of the OTC hearing aid in people younger than 18 years old as well as a warning regarding “red flag” medical conditions to prompt consumers to consult with a licensed physician and a note about how to report adverse events to FDA. Illustration(s) of and information about the controls, user adjustments, and the battery compartment. A description of any accessory that accompanies the OTC hearing aid.

• Adequate directions for use, consistent with § 801.5 (21 CFR 801.5), including but not limited to information on sizing and inserting the eartip as well as the tools, tests, or software that allow the user to control and customize the OTC hearing aid to the user's hearing needs ( e.g., to self-select, self-fit, and self-check the performance of the device). Technical specifications to allow users, prospective users, and others to evaluate and compare the performance of OTC hearing aids. Description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid.

Identification of known physiological side effects associated with using the OTC hearing aid that may warrant consultation with a physician, including but not limited to skin irritation and accelerated build-up of ear wax (cerumen accumulation). Information on repair services. And If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies.

We believe these labeling requirements for OTC hearing aids will help provide reasonable assurance of safe and effective use of OTC hearing aids for consumers with perceived mild-to-moderate hearing loss. We intend the proposed labeling requirements to provide lay consumers with adequate information, in particular, to ensure that those purchasing OTC hearing aids know when to seek professional intervention, how to use the device safely and effectively, and where and how to obtain additional information or assistance. The 2016 NASEM report supports FDA's proposal in that it similarly recommends that OTC hearing aids “[i]nclude thorough consumer labeling, including information on.

Frequency gain characteristics. Adequate directions for use. Communication challenges for which it may be helpful to seek professional consultation.

And medical situations, symptoms, or signs for which to consult with a physician” (Ref. 6). We agree that thorough consumer labeling will assist users, potential users, and others with selecting, fitting, and wearing OTC hearing aids.

Even so, the proposed requirements in this rulemaking are not intended as a substitute for other FDA regulations. Thus, for example, if adequate directions for use were to require additional information beyond that proposed in this rulemaking, manufacturers would need to include Start Printed Page 58161 that additional information (see § 801.5 regarding adequate directions for use). As for the NASEM report's recommendations for OTC hearing aids regarding information about communication challenges and medical indicators, we agree that such information will help provide reasonable assurance of safety and effectiveness, and we have included that information, as well as the full-on gain value in our proposed labeling requirements.

(Gain is a measure of amplification, and its full-on value is its maximum. We provide an explanation of gain in section III.D.2.) We are not proposing to require additional technical information in the labeling for OTC hearing aids other than those in proposed § 800.30(c)(4). However, the labeling may optionally include such information if desirable.

For example, technical information similar to what is currently required for all hearing aids may be useful in assisting audiologists offering services to users (see § 801.420(c)(4)). Multiple stakeholders voiced a similar view during the 2016 FDA workshop (Refs. 9, 10, and 12).

Some added that scientific or technical information (in addition to the information we are proposing to require for OTC hearing aids) may be meaningful for consumers to make their decisions, especially if they are familiar with the technology. Although such additional information may be desirable for some consumers, FDA does not believe it is necessary to assist consumers in their selection. FDA intends to issue at a later date a separate comprehensive guidance document that discusses, in part, labeling information and communicating that information with the goals of increasing transparency and choice to consumers.

In accordance with 21 CFR 10.115, we will announce the availability of the draft of that guidance separately from this rulemaking, and the announcement will include information for submitting comments about that guidance, which will be separate and distinct from comments for this rulemaking. We do not intend to consider comments submitted to the docket for this rulemaking unless they pertain to the proposals in this document. 3.

Labeling on the Device Itself We are proposing to require that the labeling on the device itself include the serial number and symbol(s) for proper battery insertion orientation when applicable. If the device has been used or rebuilt, a tag indicating such would have to be physically attached to the device in addition to the statement on the outside of the package. D.

Output Limits (Proposed § 800.30(d)) FDA is proposing a maximum acoustic output limit requirement for an OTC hearing aid to provide reasonable assurance of safety and effectiveness. Section 709(b)(2)(B) of FDARA directs FDA to establish or adopt output limits appropriate for OTC hearing aids. A high output can be unsafe and further impair hearing.

However, too low an output reduces device effectiveness and can lead to poor device performance, including clipping and distortion. In turn, poor performance would reduce consumer satisfaction and use of the devices. We believe that the proposed output limits balance the above considerations for these devices, so the limits are therefore appropriate for OTC hearing aids.

1. Overview of Proposed Output Limits We propose a maximum OSPL90 output level of 115 dB sound pressure level (SPL) as a general rule to balance consumer safety with device performance.[] However, we would permit a limit of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control ( i.e., volume adjustment). This is because a user-adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device's limit.

Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device's limit, at any given moment. Relatedly, we are proposing that the device labeling state the value of the maximum OSPL90 level (see section III.C.1).

We have proposed output limits to prevent injuries from exposure to loud sounds when amplified by OTC hearing aids while still allowing a sufficient dynamic range of outputs, called “headroom,” to provide effective amplification for users with perceived mild to moderate hearing loss. A device without sufficient headroom (when the output limit is too low) would not be as effective as a device with a higher output. However, a device with too high an output limit could further worsen hearing impairment.

2. Data and Stakeholder Perspectives on the Proposed Output Limit We base the proposed limits on physiological data and stakeholder input, some of which appear in Clause 4.3 of ANSI/CTA-2051, a voluntary consensus standard (Ref. 13).

Note that, although ANSI/CTA-2051 is a consensus standard for PSAPs, we believe that this standard is also relevant for OTC hearing aids, which provide personal sound amplification, albeit for purposes of aiding with or compensating for impaired hearing. The standard's basis for the output limit is a national workplace safety guideline, Occupational Noise Exposure, from the National Institute for Occupational Safety and Health (NIOSH) (Ref. 14).

NIOSH developed this standard, which we will refer to as NIOSH-98, to define permissible exposure time depending on the intensity of the sound. In general, the relationship between the loudness (SPL) and the time before damage to hearing is inversely related. The louder the sound, the shorter the time before hearing damage.

Above about 85 dBA (A-weighted decibels), the exposure time is cut in half for every 3 dB increase in sound level (Ref. 14).[] Thus, the difference between recommended exposure times for 115 dB SPL and 120 dB SPL is approximately 61 seconds, where 115 dB SPL provides approximately triple the permissible exposure time than 120 dB SPL (see the next section for a more detailed explanation of the “3-dB exchange rate”). Appendix A of ANSI/CTA-2051 describes this tradeoff between output level and exposure time, providing a rationale for a maximum OSPL90 output limit of 120 dB based on NIOSH-98.

For the purposes of that standard, NIOSH found that 115 dBA SPL is acceptable for up to about 30 seconds. ANSI/CTA-2051 explains that this allows the user sufficient time to turn off or remove the hearing aid before the exposure becomes Start Printed Page 58162 unacceptably dangerous to hearing ability. ANSI/CTA-2051 observes that sound levels of desirable, “real-life sonic events” can approach the NIOSH-98 level, for example, a live symphony in which a user would want to experience “occasional peaks” undistorted.

However, a lower output limit would not allow enough headroom for a faithful reproduction of such peaks and would lead to output clipping or distortion. Thus, a limit that allows desirable peaks, but sufficient time to react to undesirably loud sounds, would be ideal. As ANSI/CTA-2051 explains, 115 dBA is equivalent to an OSPL90 value of approximately 120 dB SPL with an allowance of 28 seconds to react.

FDA agrees that an OTC hearing aid should provide sufficient headroom to amplify relatively loud sounds such as those in a symphony, yet the device should not have an output so high that the user does not have time to act before sustaining injury. Further, the output should not be consistently at a limit of 120 dB SPL, accomplished through the inclusion of input-controlled compression and user-adjustable volume control. In addition to considering the ANSI/CTA and NIOSH standards supporting the proposed limits, we considered stakeholder input.

On June 9, 2017, NASEM held a public workshop meeting where participants discussed, among other topics, a 120-dB SPL maximum output limit for an OTC hearing aid (see Ref. 11). Numerous speakers commented that an OSPL90 output limit somewhat lower than 120 dB SPL for OTC devices would likely still provide sufficient amplification and headroom for individuals with perceived mild to moderate hearing loss while providing a safety margin in terms of sound-intensity exposure.

Additional comments during the NASEM workshop raised the importance of input-controlled compression and the inclusion of a user-adjustable volume control in order to help reduce overamplification. Each of those features can limit the device's output by dynamically reducing device gain as the input level increases, thus increasing the safety profile of a device. The user generally would not be listening at louder output levels as often as would occur without these features.

FDA has also reviewed numerous public comments on the risk of harm from excessive output, stemming from our 2016 public workshop, Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids (see Refs. 9, 15, and 16). We agree that excessive amplification from OTC hearing aids could pose a risk to individuals' health and thus are proposing that the maximum output (OSPL90) of OTC hearing aids not exceed a certain value, depending on device design features, that would provide users enough time to react to loud sounds to prevent injuries.

Some stakeholders have suggested inclusion of gain limits for OTC hearing aids. Gain is a measurement based on the ratio between the output and the input or, to simplify further, how much the device amplifies (or reduces) the input. A gain limit would further reduce the maximum device output because the device would sometimes reach the gain limit, providing no further amplification, before it reached the output limit.

We are proposing not to limit the device gain because we believe that the proposed maximum output limit (together with the other proposed requirements) will provide reasonable assurance of safety and effectiveness without limiting the device gain also. Moreover, a gain limit may unduly constrain the design of effective devices. Appropriate gain characteristics can depend on the implementation of the amplification circuit design ( e.g., linear amplification versus wide dynamic range compression).

Thus, appropriate gain settings for one device may not be appropriate for another device of a different design. We believe that allowing flexibility in the gain settings will help maximize the effectiveness of the particular circuit design a manufacturer implements for a device to address perceived mild to moderate hearing loss. In light of this, and since a maximum output limit would also in effect limit gain, we do not believe a separate, additional gain limit is necessary to provide reasonable assurance of safety and effectiveness.

We also note that the NASEM report does not recommend any limit on gain for OTC devices, only on maximum output (Ref. 6). 3.

The Proposed Output Limit Requirements Help Provide Reasonable Assurance of Safety and Effectiveness In further consideration of user-adjustable volume controls and input-controlled compression, we believe that these two design features together will sufficiently mitigate the risk of a higher maximum output limit (from 115 dB SPL up to and including 120 dB SPL) by reducing the likelihood that the user will experience excessive sound levels for periods long enough to sustain damage to hearing (Ref. 14). Input-controlled compression such as wide dynamic range compression is also associated with hearing performance benefits in realistic environments that have varying levels of sound intensity for persons with mild-to-moderate sensorineural hearing loss (see, e.g., Refs.

17 to 21). That is, besides reducing the device's effective output limit, input-controlled compression also generally helps users hear better in daily situations. In reaching this proposal on output limits, we note that hearing aids, including OTC hearing aids, are intended to be worn during all waking hours in a wide variety of listening environments and situations.

Thus, user comfort is relevant to safety and effectiveness, and input-controlled compression and user-adjustable volume control increase comfort by dynamically adjusting gain and keeping outputs lower. This contributes to effectiveness and user satisfaction because users are generally more willing to wear a comfortable device consistently, maximizing the benefits of the device and the impact on public health. We are not proposing to require input-controlled compression and a user-adjustable volume control for all OTC hearing aids, however.

Thus, devices that do not have both of these features (which, in effect, reduce the device's output limit) would have to respect a 115 dB SPL limit, which would more than triple the safe exposure time compared to a 120 dB SPL limit (Ref. 14).[] Users would have ample time to take appropriate action to mitigate unacceptably high sound levels, for example, by adjusting the volume (if the device has a user-adjustable volume control), turning the device off, removing the device from the ear, or moving out of the loud environment. As noted above, the device labeling would also be required to include a reminder to consumers that, if they are in a loud listening environment that warrants hearing protection, they should remove their hearing aid(s) and use hearing protection.

To summarize, we believe that a 115 dB SPL output limit would help provide reasonable assurance of safety and effectiveness for the intended population. However, we acknowledge that 120 dB SPL could have additional effectiveness potential in certain circumstances, for example, when listening to a symphony by a live orchestra (Ref. 13).

As discussed above, we believe that achieving that potential would be safe only if the device also Start Printed Page 58163 includes input-controlled compression and a user-adjustable volume control. Overall, we believe this device-design contingent proposal for output limits helps provide reasonable assurance of safety and effectiveness of OTC hearing aids while providing ample design space for innovation. E.

Other Requirements (Proposed § 800.30(e) and (f)) Although certain labeling and output limits are necessary for reasonable assurance of safety and effectiveness of OTC hearing aids, these requirements alone are not sufficient to do so. FDA is therefore proposing that the devices must meet certain performance and design requirements in order to help provide reasonable assurance of safety and effectiveness, pursuant to section 709(b)(2)(A) of FDARA. 1.

Electroacoustic Performance Requirements To Help Provide a Reasonable Assurance of Safety and Effectiveness We are proposing to establish electroacoustic performance requirements to help ensure that the output of an OTC hearing aid safely and effectively compensates for perceived mild to moderate hearing loss in people age 18 and older. Electroacoustic performance describes how well a hearing aid converts an electrical signal, either digital or analog, into a sound (acoustic energy) or vice versa. Currently, hearing aid labeling must include technical data for certain performance characteristics gathered according to the test methods specified in ANSI/ASA S3.22-2003 (see § 801.420(c)(4)).

We do not believe, however, that the data that conform to ANSI/ASA S3.22 are adequate for consumers to select their own hearing aid without the supervision, involvement, or intervention of a licensed person (among other reservations). This is because ANSI/ASA S3.22 does not specify any minimum performance requirements. Instead, it specifies tolerances, which are acceptable ranges of deviation from manufacturer-stated specifications.

The manufacturer, not a standard, determines how the hearing aid performs. As a result, achieving optimal hearing aid performance currently depends in part on interpreting the technical data supplied by the manufacturer for selection and adjustment. The interpretation of this information is highly technical, so the information is useful to a professional but generally not the lay user.

For OTC hearing aids, we believe that the devices must meet certain electroacoustic performance specifications so that any OTC hearing aid would perform safely and effectively for perceived mild to moderate hearing loss after the user customizes the device for individual needs. To that end, we are proposing to use several applicable specifications for device performance from ANSI/CTA-2051 for OTC hearing aids. A device that met these performance specifications would safely and effectively reproduce sounds without the need for professional involvement.

Specifically, an OTC hearing aid should provide amplification with high fidelity so that the user can accurately perceive daily social and environmental sounds. High-fidelity (accurate) output means that the device reproduces the input frequencies clearly, without distortion and without undue frequency shaping. We believe such an OTC hearing aid will have certain performance characteristics to achieve fidelity.

The OTC hearing aid would have sufficiently low distortion, would not introduce excessive self-generated noise or time delays between input and output, and would provide a sufficient frequency response bandwidth and smoothness. An OTC hearing aid would have to achieve these, after customization to the individual's hearing needs, without the intervention of a licensed professional. That is, by design.

We have reviewed ANSI/CTA-2051:2017, which includes specifications for electroacoustic performance, and we believe that performance requirements based primarily on its Category 1 specifications would help provide reasonable assurance of safety and effectiveness of OTC hearing aids.[] These specifications relate to the device's processing of the input sound (the sounds detected by the device) to generate the output sound (the amplified sound that the device produces to assist the user). To summarize, FDA believes that the specifications that would help provide reasonable assurance of safety and effectiveness, as well as set an objective baseline for device performance, are. Distortion control limits.

Self-generated noise limits. Latency limit. Frequency response bandwidth.

And Frequency response smoothness limits. We believe that the above listed electroacoustic requirements would ensure that an OTC hearing aid can accurately reproduce daily speech and other environmental sounds without the need for professional involvement. We believe that this performance level is requisite for the device to meet the needs of people with perceived mild to moderate hearing loss.

Likewise, the performance requirements would help ensure that undesirable effects (such as distortion) do not impair safety and effectiveness. ANSI/CTA-2051 is, to FDA's knowledge, the first voluntary consensus standard to describe performance characteristics for hearing amplifiers (as opposed to standardized test methods and tolerances). Upon reviewing the voluntary consensus standard, and in consideration of related presentations during FDA's 2016 hearing aid workshop, we believe that the rationale and methodology of the standard are sound, and we believe that adhering to the specifications in this standard would yield high-fidelity OTC hearing aids.

However, we are proposing to establish as requirements the subset of those specifications that we believe would help provide reasonable assurance of safety and effectiveness in conjunction with the other proposals in this rulemaking. Whether to require such electroacoustic performance specifications for OTC hearing aids, and the specific values, were topics of discussion during the June 9, 2017, NASEM public workshop (Ref. 11).

Additionally, public presentations of amplification measurements at FDA's hearing aid workshop showed performance differences and suitability in terms of frequency response bandwidth and smoothness across devices that presenters considered (Refs. 9, 15, 16, 22). After seeing such information, several participants opined that the Category 1 limits of ANSI/CTA-2051, together with the device latency limits (a Category 2 limit in ANSI/CTA-2051), would collectively help ensure safety and effectiveness of an OTC hearing aid with respect to its electroacoustic performance.

In addition to the performance aspects of the voluntary consensus standard, we recognize that aligning FDA regulations with a voluntary consensus standard may reduce administrative burdens while encouraging and facilitating greater availability of safe and effective OTC hearing aids. Note that we are not proposing to apply the electroacoustic performance requirements to Start Printed Page 58164 prescription hearing aids, nor are we proposing to establish requirements for OTC hearing aids that mirror the technical data requirements under current § 801.420(c)(4). We expect that the involvement of a licensed professional for prescription hearing aids will help provide for reasonable assurance of safety and effectiveness for those devices.

Similarly, although the technical data in current § 801.420(c)(4) will assist licensed professionals to select and fit a prescription hearing aid, we do not believe that the technical data are generally helpful for lay users of OTC hearing aids that meet electroacoustic performance requirements. a. Distortion control limits.

Distortion control limits describe how faithfully an OTC hearing aid reproduces a given frequency or range of frequencies at a given sound pressure level. An OTC hearing aid that produces less perceptible total harmonic distortion, plus hearing-aid-originated noise ( i.e., total harmonic distortion plus noise), will deliver a higher-fidelity sound to the user, meaning that the user will be able to perceive sounds more accurately or clearly than a device with higher perceptible total harmonic distortion plus noise. Total harmonic distortion plus noise can depend on both the input and output sound pressure levels and the corresponding (level-dependent) gain settings of the device if applicable.

We believe that the proposed allowable levels of total harmonic distortion plus noise, when measured as proposed at the specified sound pressure levels, will help ensure accurate or clear amplification for the user of an OTC hearing aid. b. Self-generated noise level limit.

The self-generated noise level limit describes the maximum sound pressure level of noise that the OTC hearing aid may produce, where “self-generated noise” means sounds that are present in the output but not the input. Excessive self-generated noise can obscure or overwhelm softer output sounds, preventing the user from hearing such sounds. Excessive self-generated noise may also distract or annoy users.

Appropriately limiting self-generated noise will therefore help users to hear softer output sounds as well as improve their experience by avoiding the production of perceptible noise or sounds that are not input sounds. We believe that the proposed rule will appropriately limit self-generated noise. c.

Latency limit. The latency limit describes how quickly an OTC hearing aid produces the output sound relative to the input sound. A shorter latency interval means that the device takes less time to produce the output, and when short enough, the user will not perceive a delay.

A perceived delay is generally most noticeable when the device amplifies the user's own voice, causing an effect much like an echo that can be disorienting, distracting, or annoying. We believe that the proposed latency limit will help to avoid perceptible output delays that would reduce the benefit from an OTC hearing aid. d.

Frequency response bandwidth. The frequency response bandwidth of an OTC hearing aid is the range of frequencies that the device can reproduce for the user to hear. Cutoff frequencies, both lower and upper, are the limits of the bandwidth.

The device would generally not sufficiently amplify signals with frequencies outside of these limits, meaning, below the lower cutoff or above the upper cutoff. A wider bandwidth means that the device can amplify a broader range of sound frequencies for users to hear. A bandwidth that is too narrow, especially if the upper cutoff is too low, will result in insufficient amplification of critical high-frequency sounds, including but not limited to speech sounds such as /s/,/z/,/t/, and/sh/.

We believe that the proposed required frequency bandwidth, 250 Hz to 5 kHz, will ensure amplification of daily speech or other environmental sounds because almost all such sounds typically fall between these proposed lower and upper cutoff frequencies. e. Frequency response smoothness limit.

The frequency response smoothness limit describes how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth. A uniform frequency response when graphed would correspond to a smooth and relatively uniform curve, which is the “smoothness” described by this limit. To describe this requirement, we divide the frequency range into multiple, narrower ranges called one-third octave bands.

Any given peak in a one-third octave band would have to remain below a set level compared to neighboring bands, two bands above and two bands below, based on the averages. Meeting this requirement for frequency response smoothness means that the amplification performance is consistent across frequencies for users. If a device does not amplify sounds uniformly across frequencies, the user would potentially perceive differences in intensity for different frequencies, reducing the audio fidelity and consequently the user's hearing perception.

This may include a perceptibly altered speech quality (such as undue changes in the tone or timbre of the intended sound), which may be distracting or annoying. In addition, device output that is relatively excessive at lower frequencies (compared to higher frequencies) poses an increased risk for damaging a user's hearing at lower frequencies. This is because the typical user has more residual hearing ( i.e., better hearing thresholds) at lower frequencies, consistent with a typical sloping hearing loss, the kind of hearing loss associated with aging.

We believe that the proposed frequency response smoothness limit will ensure consistent performance across frequency ranges and thereby help to provide reasonable assurance of device safety and effectiveness. f. Performance test methods.

For each of these proposed electroacoustic requirements, we are specifying performance test methods, including input and output sound pressure levels when appropriate. We are proposing specific performance test methods because different test methods could yield different results for the same metric of device performance. Thus, specifying test methods helps establish a common baseline to benchmark performance for any given device.

Additionally, a common baseline would allow prospective users and others to compare electroacoustic performance across devices. Facilitating comparison shopping may also promote users' satisfaction with the OTC hearing aids that they decide to purchase. 2.

Design Requirements To Ensure Proper Physical Fit and Prevent User Injury We are proposing that the design of an OTC hearing aid must meet certain requirements for safety and effectiveness. Maximum insertion depth. Eartip made from atraumatic materials.

Proper physical fit. And Tools, tests, or software allowing the lay user to control the device and customize it to the user's hearing needs. The above listed requirements seek to balance effective fit and safe fit of an OTC hearing aid, accomplished by users themselves, without professional assistance.

An OTC hearing aid eartip (the part of the OTC hearing aid that contacts and fits into the user's ear) must fit the user so the device performs optimally, but an OTC hearing aid must not damage the ear, including the ear canal and eardrum (tympanic membrane). The device could damage the ear by scratching (abrading) the skin around the eartip parts, puncturing the eardrum, or exacerbating hearing loss if Start Printed Page 58165 the device is too close to the eardrum. In particular, the skin that lines the ear canal is especially thin and delicate.

The lateral (outer) third of the canal is composed of cartilage, and the medial (inner) two-thirds, which ends at the ear drum, of bone. Each of these parts of the ear is therefore quite sensitive and easily injured. To provide reasonable assurance of safety and effectiveness, the design of an OTC hearing aid must allow insertion and prolonged contact with these sensitive areas while preventing injury to them.

We believe the above listed requirements would ensure proper physical fit for optimal performance while avoiding injury to the user's ear canal skin, bony inner ear canal, the eardrum, or other middle ear structures. a. Maximum insertion depth.

We considered whether we could express a design requirement for manufacturers for maximum insertion depth as a given length. However, specific anatomical dimensions such as the length of the cartilaginous and bony portions of the external auditory canal and distance to the tympanic membrane can vary greatly among adults. That is, the distance to the eardrum differs greatly from person to person.

A given length may be too long for one person (potentially resulting in injury with device insertion or placement) but too short for another (potentially impairing device performance by too shallow of an insertion). In contrast, we believe that the bony-cartilaginous junction is a readily identifiable and consistent anatomical landmark that can serve as a design limit for manufacturers of OTC hearing aids. That is, we believe a practical way to describe the depth limit is to base it on the area of the ear canal corresponding to where cartilage meets bone.

However, we welcome comments, particularly those with support from peer-reviewed sources, about other design requirements ( e.g., in terms of absolute length) to limit the insertion depth and prevent damage to the tympanic membrane or other injuries while also promoting device effectiveness. b. Construction from atraumatic materials.

We are proposing that the eartip be encased by atraumatic materials, that is, materials that prevent injuries to the skin and bone, for example, because they are very flexible. The use of atraumatic materials reduces the chance that daily use or accidental contacts will cause damage to the delicate skin or bone of the ear. c.

Proper physical fit. We are proposing that the OTC hearing aid have features that enable users to readily achieve a safe, customized, acoustically favorable, and comfortable physical fit in the ear canal and/or external ear. For example, the manufacturer may wish to provide interchangeable eartips of varying sizes.

However, we are not proposing a specific design feature or strategy because such specificity may constrain the design of an OTC hearing aid and impede design innovations. This proposed requirement corresponds with the proposed labeling requirements to describe how users may obtain such a fit, including sizing or inserting the eartip to minimize the risk of injury. d.

Tools, tests, or software. We are proposing to codify the requirement that an OTC hearing aid must include tools, tests, or software through which a lay user can control the device and customize it to the user's hearing needs. Examples of tools, tests, or software include but are not limited to.

A user-adjustable volume control, a user-adjustable tone control, the ability for a user to change preset listening programs manually, interactive software for self-selecting, testing, and fitting, or a switch to enable or disable automatically determined settings, such as acoustic environment sensing or noise cancellation. An OTC hearing aid would need to include tools, tests, or software, or some combination of those features, sufficient to customize the device to meet the user's hearing needs. 3.

QS Requirements We are soliciting further input on potential revisions to the applicable QS requirements for OTC hearing aids. The input that we have already received, while valuable, is sometimes contradictory and does not fully address FDA's concerns for the quality of medical devices. As described in section I.C, we received stakeholder input suggesting that FDA reduce the provisions of the QS regulation applicable to the devices as the provisions are overly burdensome.

We also received input that the current requirements are important and not unduly burdensome (Ref. 9). While FDA wishes to minimize regulatory burdens, we must have reasonable assurance of safety and effectiveness, which a quality system helps to provide.

In considering the range of feedback already received, we note that the QS requirements are interdependent yet inherently flexible. This scheme relies on each of the provisions working together. Further, because hearing aids are medical devices, a quality system for medical devices specifically, as opposed to a quality system for consumer electronics more generally, is necessary to provide reasonable assurance of safety and effectiveness.

This is because medical device quality systems address regulatory concerns regarding safety and effectiveness that systems for consumer electronics do not. While the use of the quality system described in part 820 would be more appropriate for OTC hearing aids and straightforward to implement than another standard with various reservations, exceptions, and modifications, FDA is open to considering alternatives to the existing QS requirements. Any such changes would be proposed in a separate rulemaking proceeding, and interested parties would have an opportunity to comment during that rulemaking.

However, we welcome proposals for how the QS requirements could be modified, or an alternate approach implemented, to ensure the quality of OTC hearing aids and provide a reasonable assurance of safety and effectiveness. Finally, with regard to the QS requirements, FDA is undertaking other separate efforts to minimize regulatory burdens for manufacturers by proposing the harmonization of part 820 with an international consensus standard. In light of the foregoing—including contradictory input already received, the inherent flexibility of the QS requirements, the need for a quality system suited to medical devices, and other changes that FDA is proposing—we are seeking further input on potential modifications to the QS requirements that would be applicable to OTC hearing aids to inform future rulemaking.

F. Condition for Sale (Proposed § 800.30(g)) FDA is proposing to establish a condition for sale of OTC hearing aids to prevent sale to people younger than 18, helping to provide reasonable assurance of safety and effectiveness. We are proposing the condition for sale pursuant to section 709(b)(2)(D) of FDARA, which directs FDA to describe the requirements under which the sale of OTC hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

For the purposes of this provision, we interpret “sale” broadly to include, among other transactions, leases and rentals. The proposed condition for sale is consistent with 709(b)(2)(C) of FDARA and section 520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids are only intended for people age 18 and older. As described above, the use of OTC hearing aids in people younger Start Printed Page 58166 than 18 presents risks to health beyond those typically associated with use in older people.

Accordingly, we are proposing to prohibit the sale of an OTC hearing aid to or for a person younger than 18 years. FDA has considered whether other conditions for sale for OTC hearing aids are necessary in addition to the proposed labeling that includes conspicuous statements that OTC hearing aids are only intended for people age 18 and older. This proposed condition for sale provides a basis for comments on the subject.

FDA also considered whether requirements on sellers to verify the age of purchasers or, in the case of online or mail-order sales, the age of the recipient, would promote the public health. However, mindful that the current conditions for sale have been criticized as described above, we believe that a requirement to obtain proof of age could make hearing aids more difficult to obtain. For example, people with limited means or mobility may not have a government-issued photographic identification that shows their birthdate.

Similarly, age verification for online or mail-order sales could impede delivery of OTC hearing aids or reduce the number of willing sellers, which could disproportionately affect OTC hearing aid access in remote or rural areas. Moreover, FDA does not expect high demand for OTC hearing aids from or for people younger than 18. Thus, a requirement for age verification could impose a barrier to access, particularly for underserved populations, without a corresponding benefit to the public health.

FDA welcomes your comments on whether a prohibition of sales to or for people younger than 18 years, without the need to verify age, would best promote access to OTC hearing aids while protecting the hearing health of people younger than 18 years. Alternatively, we welcome your comments on what other conditions for sale may protect the hearing health of people younger than 18 years. In the case of alternative conditions for sale, FDA is particularly interested in conditions that would not disproportionately burden underserved communities.

FDA is also interested in your comments on whether labeling, without the prohibition on sales, adequately protects the health of people younger than 18. We intend to minimize burdens and provide flexibility for sellers, while also protecting the hearing health of people younger than 18, helping to promote the public health by promoting the availability of OTC hearing aids for people who are 18 and older. G.

Preemption Provisions (Proposed § 800.30(h)) FDA is proposing to codify the provisions regarding preemption and private remedies under section 709(b)(4) and (5) of FDARA to assist stakeholders in understanding the legal framework for OTC hearing aids. These provisions are not codified in the FD&C Act, meaning they do not appear under Title 21 of the U.S. Code, but apply nonetheless.

We believe that including these provisions in the Code of Federal Regulations will assist our stakeholders, who may not be as familiar with requirements that are not codified in the FD&C Act, such as these, by consolidating applicable requirements in one location that is more familiar. This may be particularly helpful because FDARA added to the existing preemption framework for devices. In general, under section 521(a) of the FD&C Act, device requirements established by a State (or a political subdivision) are preempted when the requirements are different from, or in addition to, requirements applicable to the device under the FD&C Act and which relate to the safety or effectiveness of the device or to any other matter included in the requirements applicable to the device.

FDA may by regulation grant or deny exemptions to this preemption in response to an application from a State (or political subdivision) under certain conditions specified in section 521(b) of the FD&C Act. Prior to the enactment of FDARA, FDA issued regulations in response to such applications, most of them relating to hearing aids, which are codified in part 808. However, section 709(b)(4) of FDARA established preemption specific to OTC hearing aids that is different from the general rule for preemption under section 521(a) of the FD&C Act.

Although FDARA did not explicitly address the existing exemptions from preemption related to hearing aids, section 709(b)(4) of FDARA applies preemption to any requirement of a State (or local government) specifically related to hearing products, that would restrict or interfere with commercial activity involving OTC hearing aids (which, as mentioned above, we will use as shorthand in this document for the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online), that is different from, in addition to, or otherwise not identical to, FDA's regulations issued under FDARA section 709(b). We are therefore proposing to amend the scope of part 808 to reflect the additional preemption set by FDARA (see section III.I.1). 1.

FDARA Preempts State Regulation of OTC Hearing Aids Under FDARA section 709(b)(4), the OTC Hearing Aid Controls that are the subject of this rulemaking, proposed § 800.30, if finalized, would preempt any State or local requirement specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids, that is different from, in addition to, or otherwise not identical to, the OTC Hearing Aid Controls, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids. FDA interprets section 709(b)(4) of FDARA, including the terms therein, as consistent with its purpose that State or local government requirements specifically related to hearing products not restrict or interfere with commercial activity involving OTC hearing aids. For example, we interpret this provision as preempting State or local requirements specifically related to hearing products that would restrict or interfere with leases, consignments, or deliveries of OTC hearing aids, though not explicitly mentioned in FDARA, because such activities fall within the commercial activity involving OTC hearing aids covered by the provision, in this example, within the marketing, sale, dispensing, use, and/or distribution.

Further, the FDARA preemption provision applies to requirements specifically related to hearing products generally, as opposed to devices or hearing aids more specifically, where such requirements restrict or interfere with commercial activity involving OTC hearing aids. As explained, we do not interpret section 709(b) of FDARA as necessarily preempting State requirements regulating professional services such as speech pathology, audiology, or fitting. A State could, for example, continue to regulate such professional services generally.

However, to the extent State or local governments require that purchasers of OTC hearing aids seek those services, such requirements would be preempted by section 709(b)(4) of FDARA as interfering with or restricting commercial activity involving OTC hearing aids. The same would be true were a State, for example, to require providers to undertake an activity, such as certification and examination specific Start Printed Page 58167 to hearing aids, in order to sell OTC hearing aids. 2.

Generally Applicable State and Local Requirements Are Not Necessarily Preempted Under FDARA As noted in section III.B, FDA does not interpret FDARA to preempt generally applicable requirements. By “generally applicable,” we mean that the requirement relates to other products in addition to hearing products, to services not specific to hearing products, or to unfair trade practices in which the requirements are not limited to hearing products.[] Requirements that apply to any place of business that offers goods or services for sale would likely be generally applicable and therefore not preempted (see also § 808.1(d)(1)). Similarly, requirements that apply to certain places of business may be generally applicable provided the requirements do not attach on account of selling, or other commercial activity involving, hearing products.

State or local requirements that make compliance with Federal regulations enforceable by State or local authorities would also not generally be preempted. The examples below focus only on the FDARA preemption provision that applies to OTC hearing aids. a.

Example 1. For example, any given pharmacy may be subject to certain State licensing requirements that apply regardless of whether the pharmacy sells OTC hearing aids. It would not be exempt from such licensing requirements merely because it sells OTC hearing aids.

Similarly, a requirement to include terms of sale or return on the receipt that applied also to the sales of other (non-hearing) products would not be preempted. b. Example 2.

In contrast, requirements that attach on account of the sale of hearing products (or would not attach but for the sale of hearing products), would not be “generally applicable.” For example, a requirement that any place of business must obtain a license or certification to sell OTC hearing aids would be a requirement specifically related to hearing products. In addition, it would serve to restrict or interfere with commercial activity involving OTC hearing aids and would be different from, in addition to, or not otherwise identical to, the regulations issued under section 709(b) of FDARA. Therefore, it would be preempted.

A requirement may attach on account of the sale of hearing products in a more indirect manner as well, and if it was in effect different from, in addition to, or not otherwise identical to the terms of the statute or Federal regulations, and if it restricted or interfered with commercial activity involving OTC hearing aids, it would be preempted. That is, a State or local requirement may appear on its face to be generally applicable, but if in practice it was specifically related to hearing products and would restrict or interfere with commercial activity involving OTC hearing aids, the State or local requirement would be preempted. c.

Example 3. A requirement that a retailer may only sell OTC hearing aids when it has an audiologist on premises would require the involvement of a licensed person in at least some cases. This requirement would restrict or interfere with commercial activity involving OTC hearing aids, including by requiring the involvement of a licensed person, and would be preempted.

d. Example 4. Similarly, a requirement that sellers advise purchasers of any hearing aids, whether prescription or OTC, of specific medical information not required in the OTC Hearing Aid Controls would be preempted with respect to the sale of OTC hearing aids.

Although the requirement attaches on account of the sale of hearing aids more generally (not just OTC devices), it is “specifically related to hearing products” and would operate as a condition of sale that is different from, in addition to, or otherwise not identical to those proposed in this rulemaking. The requirement would also restrict or interfere with commercial activity involving OTC hearing aids. Therefore, the requirement would be preempted as applied to the sale of OTC hearing aids.

e. Example 5. A professional or ethical requirement that deemed a sale to be professional malpractice if the dispenser permitted the sale of any hearing aid without consultation would be preempted under FDARA.

It specifically relates to hearing products and by requiring consultation prior to the sale of an OTC hearing aid, it would restrict or interfere with commercial activity involving OTC hearing aids even though the requirement on its face applies only to the dispenser (who must meet licensing requirements). f. Example 6.

A requirement that a seller maintain a statement of medical examination, in connection with the sale of a hearing product, would be preempted under FDARA because such a condition of sale would restrict or interfere with commercial activity involving an OTC hearing aid. Moreover, the requirement for a statement of medical evaluation would restrict or interfere with commercial activity involving OTC hearing aids by requiring the involvement of a licensed person during the course of the commercial activity. 3.

Requirements for Professionals and Establishments As with generally applicable requirements, we do not interpret section 709 of FDARA as generally prohibiting the regulation of professionals or establishments or exempting them from applicable professional requirements, even in the case that the professional or establishment only undertakes activities related to OTC hearing aids. Thus, a person that purports to be a specially licensed professional or establishment would be subject to applicable State and local requirements. Such requirements may include periodic professional examination or mandating the availability of testing equipment.

FDA does, however, interpret section 709 of FDARA as preempting certain kinds of professional or establishment requirements. To use one specific example, many States have established definitions for hearing aid fitters, dispensers, or other sellers and servicers. In some cases, State or local requirements may deem an individual or establishment to be a dispenser (or other defined term) by virtue of engaging in the sale of or providing services for hearing aids.

That status in turn incurs legal obligations. As explained, we interpret section 709 of FDARA as preempting such requirements to the extent that they would require the involvement of a licensed person for consumers to access OTC hearing aids or would otherwise restrict or interfere with commercial activity involving (the servicing, marketing, sale, dispensing, use, customer support, or distribution of) OTC hearing aids. For the reasons explained in section III.B regarding the definition of “licensed person,” we are specifying certain related terms that would not on their own, as they relate to OTC hearing aids, indicate professional or specialized obligations.

For example, under the proposed definition of “licensed person,” identifying as a Start Printed Page 58168 hearing aid “dispenser” would not imply licensure. Note that we would consider a person identifying as a “licensed dispenser” to be subject to State or local requirements applicable to licensed dispensers and therefore considered a “licensed person” under section 709(b)(4) of FDARA. The examples below focus only on the FDARA preemption provision that applies to OTC hearing aids.

a. Example 7. In contrast to identifying as a dispenser (without using the word “licensed”), as proposed, identifying as an audiologist or hearing aid fitter, for example, may imply licensure, depending on State and local requirements.

Thus, a person who advertises as an audiologist or hearing aid fitter—professional services that may be provided, but cannot be required to be provided, to sell OTC hearing aids—would be subject to State requirements that apply to audiologists or hearing aid fitters. This would be true even if such an audiologist or fitter only sold OTC hearing aids. b.

Example 8. In contrast, a person who advertises as a hearing aid dispenser or seller, and who only sells OTC hearing aids, cannot be required to obtain specialized licenses to engage in commercial activity involving OTC hearing aids. c.

Example 9. As in Example 7, a person who only sells OTC hearing aids but advertises as a licensed dispenser even though such licensing is not required to sell OTC hearing aids—the person purports to be a licensed person, not a “dispenser” more generally—would be subject to State or local requirements that apply to licensed dispensers. We are proposing a preemption provision that speaks specifically to professional requirements in order to clarify in the regulations that the servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids, on its own, does not obligate a person to obtain specialized licenses, certificates, or any other State or local sanction.

H. Proposed Repeal of Conditions for Sale and Modifications for Prescription Labeling (§§ 801.420, 801.421, 801.422) FDA is proposing to repeal the conditions for sale for hearing aids, § 801.421, because these would no longer be necessary. Currently, those conditions apply to all hearing aids, but section 520(q)(2) of the FD&C Act specifies that OTC hearing aids will be exempt from §§ 801.420 and 801.421 or any successor regulations.

Instead of continuing to apply those conditions to non-OTC hearing aids, FDA is proposing to repeal them. Additionally, FDA is proposing to remove the current labeling requirements for hearing aids in § 801.420 and issue prescription labeling requirements under § 801.422, which would be in addition to the prescription labeling requirements in § 801.109. The repeal of § 801.421 and the amendments to the labeling requirements (amending the current labeling requirements, moving them to a new section, and removing § 801.420) would have further regulatory implications.

In proposing new § 801.422, FDA is not relying on its restricted device authority in section 520(e) of the FD&C Act. Therefore, if this proposed rule is finalized, class I and class II hearing aids would no longer be “restricted devices” under section 520(e) of the FD&C Act. As such, certain Federal requirements related to restricted devices would no longer apply to class I and class II hearing aids.

Further, the basis for some of FDA's exemption decisions about preempted State requirements would change. The next section of this document discusses those changes along with the additional Federal preemption implications of FDARA and how we would remove, update, or clarify those regulations. Repeal of the conditions for sale would also obviate the need for the guidance entitled “Conditions for Sale for Air-Conduction Hearing Aids”.

If the repeal of the conditions for sale is finalized, we would withdraw that guidance (Ref. 8). 1.

Repeal of Conditions for Sale § 801.421 As summarized in section I.C.2, the conditions for sale of hearing aids under § 801.421 require a statement of medical evaluation, unless waived by a user 18 years of age or older. The availability of a user instructional brochure and an opportunity to review it. And records of the statements of medical evaluation or waiver.

The conditions also provide an exemption from the requirements in § 801.421 for auditory trainers. In light of the fact that FDA is proposing to clarify that non-OTC hearing aids would be prescription devices, such hearing aids would be subject to State and local requirements for obtaining written or oral authorization of a practitioner licensed by State law to administer the use of the devices. For example, some States license audiologists to administer the use of prescription hearing aids for an adult, so adults could obtain a prescription for hearing aids from an audiologist in those States.

In the case of people younger than age 18, the proposed prescription labeling statements described in the next section of this document would in manner and form emphasize the importance of medical evaluations. Because prescription hearing aids will require a written or oral authorization from a practitioner licensed by law to administer the device, and because we are proposing certain labeling requirements in a certain manner and form, FDA is proposing to repeal the conditions for sale (including the requirement for a medical evaluation and for providing a user instructional brochure) because they would no longer be necessary to provide reasonable assurance of safety and effectiveness of prescription hearing aids. Thus, hearing aids that do not meet the definition of, or the requirements for, OTC hearing aids would all be prescription hearing aids, but they would no longer be restricted devices.

We expect that the application of prescription requirements with the removal of device restrictions will not increase the burden to obtain non-OTC hearing aids, and that the change will promote consistency with other products, easing the burden on purchasers. Specifically, hearing aids will be either prescription or OTC. Users and other interested people would not also need to inquire whether a device is restricted.

Additionally, repeal of the requirements discussed above would obviate the need for the exemption for group auditory trainers, which we are correspondingly proposing to repeal. 2. Revised Labeling for Prescription Hearing Aids We continue to believe that the labeling requirements are necessary to provide reasonable assurance of safety and effectiveness of prescription hearing aids.

As such, we are proposing to retain most of the required information currently in § 801.420 in substance, except as revised below, and place the proposed revised labeling requirements that would be specific to prescription hearing aids in § 801.422, thereby removing § 801.420. These proposed revisions are to ensure that the wording is consistent with and similar to the proposed labeling statements for OTC hearing aids when appropriate. In particular, we are proposing to revise the labeling statements to be more understandable and, when addressed to users and prospective users, less technical.

In general, as summarized in section II, a device's labeling must bear adequate directions for use and certain adequate warnings in the manner and form necessary to protect the user (see section 502(f) of the FD&C Act). We Start Printed Page 58169 have defined “adequate directions for use,” in part, as directions by which a layperson can use the device safely and for the purposes for which it is intended (see § 801.5). However, we have exempted prescription devices from the requirement for labeling to bear adequate directions for use provided they meet certain conditions (see § 801.109).

For prescription devices, labeling must bear, among other statements, information for use under which practitioners licensed by law to administer the device can use it safely and for the purpose for which it is intended (see § 801.109(c)). In any case, the labeling for a device must not be false or misleading in any particular (see section 502(a)(1) of the FD&C Act). Labeling may be false or misleading because, among other reasons, it fails to reveal facts material to its use (see section 201(n) of the FD&C Act).

Therefore, prescription hearing aid labeling must include certain adequate warnings as well as information for the licensed professional to use the device safely and for the purpose for which it is intended, and the labeling must not fail to reveal certain material facts. To determine whether those requirements are met, we consider the sale, distribution, and use of prescription hearing aids. In the case of prescription hearing aids, a prospective user would obtain one from a practitioner licensed by law in that State.

However, the professional qualifications for fitters and other licensed practitioners, as well as dispensers more generally, vary widely. Therefore, we are proposing to require information for dispensers to ensure necessary warnings are conveyed in an adequate manner and form for every device. The proposal includes warnings.

(1) Of possibilities for underlying pathological conditions, (2) against use in people younger than 18 without a medical evaluation, and (3) of injury potential from high output. We are further proposing to require the disclosure of certain technical specifications, which is necessary to provide fitters and dispensers information for the safe and effective use of the device. This information is material to the use of the device, as this information would be necessary for a hearing health professional to select an appropriate device.

Without this information, a hearing health professional would be unable to determine a safe and effective device for the user without unnecessarily increasing the risks to health to the user. This provision includes a proposed requirement that measurement of the specifications conforms to ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” to provide for uniformity in testing and measurement, which in turn aids hearing health professionals in selecting or fitting an appropriate prescription hearing aid. The proposed user labeling requirements are also intended to provide adequate warnings against use in certain pathological (“red flag”) conditions, and by children, where the use would be dangerous to health.

As well as adequate warnings against unsafe dosage or methods or duration of administration or application. We propose that this manner and form are necessary for the protection of the users. Once a user obtains a prescription hearing aid, use of the device occurs without direct supervision of a licensed professional, and notably, such use is generally intended to occur over long periods each day, every day.

Therefore, in addition to the proposed information for hearing health professionals summarized above, we are proposing warnings and information specifically for users. We intend this information to be more understandable for laypeople while communicating warnings against use in certain pathological (“red flag”) conditions, against use in children without a medical evaluation, and in a manner and form that are necessary for the protection of the users. For the reasons explained above, we believe that the proposed labeling requirements for prescription hearing aids are necessary to provide reasonable assurance of safety and effectiveness.

This proposal also maximizes consistency with OTC hearing aid labeling to reduce the burden on manufacturers that wish to offer both categories of hearing aids. Although we are proposing the foregoing warnings and information in manner and form as are necessary for the protection of users, the specificity of this proposal would also encourage uniformity while conveying essential information appropriate for the type of hearing healthcare delivery. By minimizing burdens and fostering familiarity, the specificity and consistency would also help promote availability and use of prescription devices.

To provide for clarity and efficient enforcement of the FD&C Act, FDA is proposing to provide explicitly that a prescription hearing aid that does not satisfy the labeling requirements of proposed § 801.422, if finalized, would be misbranded under sections 201(n), 502(a), and 502(f) of the FD&C Act. Moreover, as explained, we believe that the labeling statements as we propose to revise them are material to and necessary for the safe and effective use of prescription hearing aids. Thus, we believe that an explicit misbranding provision in the prescription labeling requirements will provide for clarity as well as the efficient enforcement of the FD&C Act.

If we finalize the repeal of the conditions for sale under § 801.421, we would correspondingly withdraw the guidance document entitled “Conditions for Sale for Air-Conduction Hearing Aids” because that guidance announces our policy regarding certain provisions of § 801.421 and would cease to be relevant (Ref. 8). I.

Proposed Amendments to Previous Exemption Decisions (Part 808) A State or a political subdivision ( e.g., a city) may not establish or continue in effect its own requirement with respect to a device for human use if that requirement is different from, or in addition to, a requirement applicable under the FD&C Act to the device (see section 521(a) of the FD&C Act). Under section 521(b) of the FD&C Act, upon application of a State or political subdivision of a State, FDA may, by regulation, exempt from preemption a State or political subdivision requirement applicable to a device if. (1) The requirement is more stringent than a requirement under the FD&C Act that would be applicable to the device if an exemption were not in effect or (2) the requirement is required by compelling local conditions and compliance with the requirement would not cause the device to be in violation of the FD&C Act.

FDA has granted some exemption requests and most, if not all, of FDA's decisions to grant exemption from preemption were based on the State or local requirement being more stringent. FDA's decisions on States' applications for exemption from Federal preemption under section 521 of the FD&C Act are codified in regulations under part 808, subpart C. The regulations codifying these decisions include both granting and denial of exemption from preemption.

Therefore, “exemption decisions” as used in this document include both types of decisions. Most of the applications for exemption from Federal preemption related to State medical device requirements that apply to hearing aids, as they existed at the time of the exemption decisions, and that were different from or in addition to the requirements in §§ 801.420 and/or 801.421. Because FDARA directs FDA to establish different requirements for some hearing aids that are not subject to section 521(b) of the FD&C Act, many of the current exemption decisions would not accurately reflect the regulatory Start Printed Page 58170 framework for hearing aids under FDARA and the FD&C Act as amended.

Moreover, if we finalize the changes we are proposing to the existing requirements for hearing aids in §§ 801.420 and 801.421, the previous exemption decisions based on those requirements may no longer apply. 1. Exemption Decisions Under Section 521(b) Are Affected by FDARA (Proposed § 808.1(g)) As explained in section III.G of this document, and as indicated above, some decisions on exemption from Federal preemption under section 521(b) of the FD&C Act would no longer accurately reflect the applicability of State requirements after the enactment of FDARA and upon establishing the OTC category of hearing aids.

To assist stakeholders to understand the changes effected by FDARA, we are proposing to codify how FDARA limits the scope of exemption decisions under section 521(b) of the FD&C Act. We believe this proposal will provide a concise reference for stakeholders to ascertain the changes effected by FDARA. Note that we are not considering exemptions from section 709(b)(4) of FDARA for State or local requirements.

This is because FDARA does not provide a parallel mechanism to exempt State or local requirements regarding hearing products that would restrict or interfere with commercial activity involving OTC hearing aids. We refer to preemption under section 709(b)(4) simply to clarify how FDARA affects State and local requirements. 2.

Removal of Regulations Codifying Exemption Decisions Affected by Amendments to § 801.420 and Repeal of § 801.421 if Finalized As explained above, FDA's exemption decisions are codified in regulations under part 808, subpart C. These decisions were issued in the 1980s and apply to the specific State provisions identified in the regulations and the specific Federal requirements in effect at the time. As mentioned above, most of the exemption decisions related to State medical device requirements that apply to hearing aids and that were different from or in addition to the requirements in §§ 801.420 and/or 801.421.

We are proposing to remove all of the regulations in part 808 related to hearing aids. That is, almost all regulations codifying the previous decisions in §§ 808.53 through 808.101, except for the portions of § 808.55 (California) that do not relate solely to hearing aids. We are proposing this because the exemption decisions codified in those regulations may no longer apply due to changes to the Federal hearing aid requirements as proposed in this rulemaking and changes to the specific State provisions we have identified in those regulations since the decisions were made over 30 years ago.

In particular, the repeal of the conditions for sale would eliminate specific Federal requirements that preempt certain State or local requirements. As such, whether we previously granted or denied exemptions, the exemption decisions would no longer apply because the State or local requirements that differed from, or were in addition to, § 801.421 would no longer be preempted. Therefore, we are proposing to remove the State-specific regulations in part 808 codifying exemption decisions pertaining to the conditions for sale for hearing aids because those decisions would no longer be applicable if the conditions for sale are repealed.

Also, the proposed amendments to the hearing aid labeling requirements may affect the exemption decisions relating to § 801.420. Although the proposed § 801.422 is similar to § 801.420 in that it too would address labeling for hearing aids, the labeling requirements are not identical to those in § 801.420 and include substantive changes. Moreover, FDA is aware that several States have modified their requirements that were the subject of the exemption decisions since they applied for exemptions, in which case the exemption decision may no longer be applicable.

Thus, not only will the Federal requirements change, but the State requirements that were the subject of the exemption decisions may have changed too since the decisions were made. Given that the exemption decisions were based on specific Federal requirements and specific State requirements that existed at the time of the decision, changes in either may affect those decisions such that they are no longer applicable. Because the exemption decisions relating to hearing aid labeling requirements may no longer be applicable, we are proposing to remove the regulations codifying these decisions.

We specifically seek comments from the States regarding the proposed removal of the regulations in part 808, subpart C, codifying these exemption decisions. For example, if a State disagrees with the proposed removal of the regulation(s) in part 808, subpart C, because the State believes the exemption decision still applies, a statement and explanation why in the comments may be helpful. We note that when § 801.422 is finalized and in effect, no State or political subdivision of a State may establish or continue in effect with respect to prescription hearing aids, any requirement which is different from, or in addition to, any requirement in § 801.422 (see section 521(a) of the FD&C Act).

However, a State or political subdivision thereof may apply for an exemption from preemption by following the process in part 808 for any requirement that is preempted by § 801.422 (see also section 521(b) of the FD&C Act). J. Other Proposed Amendments FDA is proposing several amendments to provide for consistency, including with the proposals in this rulemaking, if finalized, and to improve clarity.

We are proposing the following. To realign the hearing aid classification regulations by sound conduction mode so that legacy air-conduction hearing aids, wireless air-conduction hearing aids, and self-fitting air-conduction hearing aids would be under one classification regulation. Bone-conduction hearing aids would be under a separate classification regulation.

To clarify that air-conduction hearing aids are subject to § 800.30 or § 801.422, as applicable, and bone-conduction hearing aids are subject to § 801.422. To revise the special control currently in § 874.3305(b)(1) for consistency with the special control currently in § 874.3325(b)(3). Although the proposed revision to § 874.3305(b)(1) would require demonstration of electrical safety and thermal safety, we believe that generally manufacturers of wireless air-conduction hearing aids regulated under § 874.3305 have been evaluating these safety aspects for their devices and therefore, this proposed revision would have little to no impact on these manufacturers.

To revise the special controls for wireless hearing aids currently in § 874.3305(b) and for self-fitting hearing aids currently in § 874.3325(b) to eliminate redundancy, for example, removing special controls that would be addressed by the proposed labeling requirements for both OTC and prescription hearing aids. To revise §§ 874.3315 and 874.3950 to clarify that these devices are subject to the prescription hearing aid labeling requirements, including in proposed § 801.422. • To clarify that a tympanic membrane contact hearing aid under § 874.3315 is a wearable device for Start Printed Page 58171 purposes of prescription hearing aid labeling.

We are also proposing non-substantive modifications to the decisions regarding exemption from Federal preemption in part 808 to assist stakeholders to understand the subject matter of the individual exemption decisions. 1. Realignment of Hearing Aid Classification Regulations by Sound Conduction Mode To increase clarity and to reduce administrative burdens associated with interpreting regulations, we are proposing to separate the classification regulations for bone-conduction and air-conduction hearing aids.

We believe this will increase clarity because air-conduction devices are technologically more similar to each other than they are to bone-conduction devices. In addition, section 520(q)(1)(A)(i) defines an OTC hearing aid as a device that, among other criteria, uses the same fundamental scientific technology as air-conduction hearing aids that are wearable devices. Therefore, bone-conduction hearing aids do not fall within the scope of the OTC hearing aid definition and moving them to a separate classification regulation (proposed § 874.3301) will help make that clear.

Tympanic membrane contact hearing aids also do not fall within the scope of the OTC hearing aid definition because, among other reasons, they do not use the same fundamental scientific technology as air-conduction hearing aids, and as specified in § 874.3315, they will continue to be regulated as prescription devices. The proposed realignment of the air-conduction hearing aid types would also locate all OTC hearing aids within the same classification regulation. However, not all air-conduction hearing aids would be OTC hearing aids.

For example, high-output air-conduction devices would be prescription. Further, transcutaneous air conduction hearing aid systems entail surgical implantation of a tube to conduct sound, so we do not consider them suitable for OTC availability. The devices will continue to be regulated under § 874.3950.

The realignment will not affect any device that does not use the same fundamental scientific technology, such as cochlear implants (product code MCM) or implantable middle ear hearing devices (product code MPV). In realigning the regulations by sound conduction mode, we are not proposing to reclassify any device or change the exemption status under section 510(m)(2) of the FD&C Act for premarket notification for any device type (see 21 U.S.C. 360(m)(2)).

For example, wireless air-conduction hearing aids regulated under § 874.3305 would continue to be class II exempt, subject to the limitations of exemption in § 874.9, and special controls would continue to apply to these devices in addition to the general controls. (The proposed general controls under § 800.30 or § 801.422, if finalized, would also apply.) As of the effective date of the final rule, we would realign current product codes to correspond with the revised regulation numbers for consistency but would not otherwise change the codes. Also, we would change the name of each classification regulation to reflect the sound conduction mode.

Note that the regulation for air-conduction hearing aids would embody a split classification, where different devices under the regulation would have different classifications and special controls depending on the technology and design. As discussed above, we would also amend the wireless hearing aid special controls to provide for consistency with the special controls for self-fitting hearing aids, and we would amend the special controls for wireless hearing aids and self-fitting hearing aids to eliminate redundancy. 2.

Non-Substantive Revisions to Exemption Decisions for Clarity and Ease of Use In addition to the amendments in part 808 explained in section III.I., we are proposing to amend the remaining State-specific regulation in part 808 to include paragraph headings that would appear in italics. Currently, the regulations do not include paragraph headings and, as such, require stakeholders to look elsewhere to understand the content of the State or local requirements as they were at the time FDA made an exemption decision. The paragraph headings will assist stakeholders by briefly describing the subject of the individual exemption decisions, thereby providing additional information and context for stakeholders.

IV. Findings Regarding Premarket Notification FDA may, in appropriate circumstances, exempt a class II device from premarket notification requirements under section 510(m)(2) of the FD&C Act. Section 709(b)(3) of FDARA directs FDA to make such findings, that is, to determine whether OTC hearing aids require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.

As described in section I.B, legacy and wireless air-conduction hearing aids are exempt from section 510(k) subject to the limitations of exemption, and we are not proposing to alter the exemption status of such devices. Self-fitting air-conduction hearing aids are not currently exempt. FDA classified this device type in October 2019 (see 84 FR 57610), and the Agency does not have sufficient information or experience with this device type to exempt these devices from premarket notification.

Accordingly, FDA has determined that, at this time, reports under section 510(k) continue to be necessary to provide reasonable assurance of safety and effectiveness. We therefore do not propose to exempt them at this time. V.

Proposed Effective and Compliance Dates A. Effective Date FDA proposes that this rule, if finalized, be effective 60 days after the publication of the final rule in the Federal Register. We propose the following compliance dates.

B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior to the Effective Date For hearing aids that have not been offered for sale prior to the effective date of the final rule, or have been offered for sale but are required to submit a new 510(k) under 21 CFR 807.81(a)(3), compliance with the new or revised requirements applicable to the hearing aid, and obtaining 510(k) clearance if applicable, must be achieved before marketing the device on or after the effective date of the final rule. If a person ( e.g., manufacturer) markets such a device without complying with the new or revised requirements or if applicable, receiving 510(k) clearance, then FDA would consider taking action against such person under our usual enforcement policies.

C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to the Effective Date For hearing aids that have been legally offered for sale prior to the effective date of the final rule, including those that already have a 510(k) clearance, compliance with the new or revised requirements that apply to the hearing aid must be achieved 180 days after the effective date of the final rule ( i.e., 240 days after the publication of the final rule). After that date, if a person ( e.g., manufacturer) continues to market such a device but does not comply with the new or revised requirements that apply to the device, then FDA would consider taking action Start Printed Page 58172 against such person under our usual enforcement policies.

At present, legacy and wireless air-conduction hearing aids are exempt from section 510(k) of the FD&C Act, subject to the limitations of exemption described in § 874.9. (Legacy hearing aids are class I devices and are 510(k) exempt under section 510( l )(1) of the FD&C Act.) However, self-fitting air-conduction hearing aids are not exempt and, therefore, are subject to premarket notification requirements. We believe that modifications to hearing aids, including labeling changes, to comply with the proposed OTC Hearing Aid Controls may exceed the limitations of exemption, for example because the device was formerly intended for use by healthcare professionals only.

We believe that labeling changes for such hearing aids to comply with the proposed prescription hearing aid labeling requirements are less likely to exceed the limitations of exemption. VI. Preliminary Economic Analysis of Impacts We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C.

601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages. Distributive impacts. And equity).

Based on our preliminary analysis, OMB's Office of Information and Regulatory Affairs has determined that this proposed rule is an economically significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We believe we can certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The estimated annualized cost over 10 years is $0.009 million per firm, which is unlikely to represent more than 3 percent to 5 percent of the revenue of an affected manufacturer. However, we note that some uncertainty exists as to these impacts, so we have chosen to draft an initial regulatory flexibility analysis. We request comments relating to the effect of this proposed rule on small manufacturers.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount. The proposed rule, if finalized, would define a new regulatory category for OTC hearing aids and make corresponding changes to the existing regulatory framework, including defining hearing aids not meeting the proposed OTC requirements as prescription medical devices, as well as providing new labeling requirements for both OTC and prescription hearing aids.

This proposed rule, if finalized, would generate potential cost savings for consumers with perceived mild to moderate hearing loss who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online. The proposed rule, if finalized, would also generate costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule. Table 3 summarizes our estimate of the annualized costs and the annualized benefits of the proposed rule, if finalized.

Table 3—Summary of Benefits, Costs and Distributional Effects of Proposed RuleCategoryPrimary estimateLow estimateHigh estimateUnitsNotesYear dollarsDiscount rate (%)Period covered (years)Benefits:Annualized Monetized $millions/year$63 63$6 6$147 1472020 20207 310 10Annualized Quantified7 3QualitativePotential increase in hearing aid and hearing technology use, leading to associated health benefits, potential fostering of innovation in hearing aid technology.Costs:Annualized Monetized $millions/year1 11 12 22020 20207 310 10Annualized Quantified7 3QualitativePotential loss of consumer utility from inability to buy existing hearing aids under existing conditionsTransfers:Federal Annualized Monetized $millions/year7 3From/ToFrom:To:Start Printed Page 58173Other Annualized Monetized $millions/year7 3From/ToFrom:To:Effects:State, Local or Tribal Government:Small Business:Wages:Growth. We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref.

23) and at https://www.fda.gov/​about-fda/​reports/​economic-impact-analyses-fda-regulations. VII. Analysis of Environmental Impact FDA has carefully considered the potential environmental impact of this proposed rule and of possible alternative actions.

In doing so, the Agency focused on the environmental impacts of its action as a result of increased use and eventual disposal of OTC hearing aids that will need to be handled if the proposed rule is finalized. The environmental assessment (EA) considers environmental impacts related to additional waste to landfills at municipal solid waste (MSW) facilities. The proposed action would increase the availability and use of hearing aid devices, which would result in additional waste from increased disposal of these devices and their associated batteries and an increase in industrial waste associated with any domestic production to meet market demand for the new devices.

Overall, given the current limited use of these devices, projected slow growth with increase in availability, and the small mass of waste material to be disposed or recycled, the proposed action is not expected to have a significant impact on MSW, landfill facilities, and the environment. The Agency has concluded that the proposed rule will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an EA prepared under 21 CFR 25.40, are on display with the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m.

And 4 p.m., Monday through Friday. They are also available electronically at https://www.regulations.gov. FDA invites comments and submission of data concerning the EA and FONSI.

VIII. Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501-3521).

A description of these provisions is given in the Description section of this document with an estimate of the annual recordkeeping and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing each collection of information. FDA invites comments on these topics.

(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility. (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. (3) ways to enhance the quality, utility, and clarity of the information to be collected.

And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title. Medical Device Labeling Regulations.

OMB Control Number 0910-0485—Revision. Description. FDA is proposing to establish a regulatory category and related rules for OTC hearing aids to improve access to hearing aid technology for Americans.

FDARA amended the FD&C Act by placing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls, which is what these rules would be. Alongside the OTC category, we are proposing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the eventual OTC category while continuing to provide a reasonable assurance of safety and effectiveness. We believe the proposals set forth in this rulemaking will promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.

The set of general controls we are proposing, Over-the-Counter Hearing Aid Controls, would apply to all hearing aids that meet the definition of an OTC hearing aid under the FD&C Act, regardless of the device's class. Among other provisions, the controls would include requirements for labeling and device design, as well as a condition for sale to prevent the sale and use of the devices by people younger than age 18. We are also proposing to remove the labeling requirements in the existing restrictions but establish a new regulation for labeling specific to prescription hearing aids.

The new prescription labeling requirements would be similar to the current labeling requirements but maintain consistency with the new labeling requirements for OTC hearing aids (for example, so that “red flag” conditions, as revised, will be the same). We are proposing to repeal the other existing restrictions, i.e., the conditions of sale, because, if this rule is finalized as proposed, the new labeling requirements for prescription hearing aids, the requirement for a prescription, and other existing requirements would provide reasonable assurance of safety and effectiveness. Description of Respondents.

Respondents to the information collection are manufacturers of hearing aids. Start Printed Page 58174 We estimate the burden of the collection of information as follows. Table 4—Estimated One-Time Burden 1  2ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursTotal capital costsUnderstanding and implementing new regulatory requirements from hearing aids rule105110528429,820$4,100,000Hearing aids relabeling.

One-time burden10588406857,1206,000,0001  There are no operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Table 5—Estimated Annual Recordkeeping Burden 1  2Activity. 21 CFR sectionNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hoursProposed labeling disclosures under 800.30(c)(2) and 801.422(c)(2).

Hearing aids. Electronic version of user instructional brochure105884018401  There are no capital costs or operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Table 6—Estimated Annual Third-Party Disclosure Burden 1  2Activity.

21 CFR SectionNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hoursOTC Hearing Aid Controls—800.3010577351913,965Prescription Hearing Aid Labeling—801.4221051105191,995Total15,9601  There are no capital costs or operating and maintenance costs associated with this collection of information.2  Numbers have been rounded to the nearest whole number. Our burden estimate is based on FDA Uniform Registration and Listing System data. FDA's Operational and Administrative System for Import Support data.

Informal communications with industry. And our knowledge of and experience with information collection pertaining to medical device labeling. We intend the burden estimates to be consistent with our Preliminary Regulatory Impact Analysis (PRIA) for this rulemaking (Ref.

23). Estimated One-Time Burden. OTC Hearing Aids proposed rule—one-time burden (Recordkeeping).

As noted in the PRIA for this proposed rule, we estimate it will take 3 hours each for an executive, a lawyer, and a marketing manager to read and understand the rule. Also included in our estimate is time for revising guidelines or standard operating procedures. We assume this may take up to 25 hours for one executive, up to 100 hours for one marketing manager, and up to 150 hours for one technical writer.

Therefore, we estimate a one-time recordkeeping burden of 284 hours for each manufacturer. OTC Hearing Aids proposed rule — one-time relabeling burden (Third-Party Disclosure). The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840).

The labeling cost model used in the PRIA suggests, based on a compliance period of 6 months, a one-time estimated third-party disclosure burden for relabeling of about 68 hours per product. We request comments on these estimates. Estimated Annual Burden.

Over-the-Counter Hearing Aid Controls—§ 800.30 (Recordkeeping and Third-Party Disclosure). Proposed § 800.30 sets forth labeling requirements for OTC hearing aids. Proposed § 800.30(c)(1) describes the warnings and other important information that the outside package must bear.

Additionally, manufacturers must include on the outside package label a weblink to all labeling and any additional resources, their return policy or lack thereof, and, if the OTC hearing aid is used or rebuilt, they must declare that fact. Proposed § 800.30(c)(2) describes device-specific requirements for labeling, inside the package. Among the labeling requirements listed are a user instructional brochure, an electronic version of which is to be made available for download.

Additional warnings. Caution and notices for users. Other specified information.

And any other information necessary for adequate directions for use as defined in § 801.5. Also required under proposed § 800.30(c)(2) is the identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician. The technical specifications required by § 800.30(c)(4).

A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid. If applicable, information regarding repair service. And, if applicable, a summary of all clinical or non-clinical studies Start Printed Page 58175 conducted to support the performance of the OTC hearing aid.

Proposed § 800.30(c)(3) provides requirements for the labeling on an OTC hearing aid itself, specifically, name of the manufacturer, model name or number, serial number, and year of manufacture and if applicable, information regarding the battery. Also, if the OTC hearing aid is used or rebuilt, the manufacturer must physically attach a removable tag to the hearing aid declaring that fact. We include no estimate for provisions under proposed § 800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) and (B), and (c)(2)(iii)(A) through (D) because we consider the labeling to be “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public,” consistent with 5 CFR 1320.3(c)(2).

Thus, those labeling provisions are not within the definition of collection of information. The PRIA for this proposed rule estimates that 105 firms manufacture air-conduction hearing aids sold in the United States, based on FDA Medical Device Registration data. We estimate that each manufacturer has an average of eight products that would need relabeling.

For each hearing aid product, we assume a 1-hour annual recordkeeping burden for maintaining the electronic version of the user instructional brochure (under proposed §§ 800.30(c)(2) and 801.422(c)(2)). The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840) according to either the proposed OTC or prescription hearing aid labeling requirements. While we lack specific data regarding what portion of hearing aids will be relabeled as prescription devices and what portion will be relabeled as OTC hearing aids, for this analysis, we assume that 10 percent will be relabeled as prescription medical devices (about 1 product per manufacturer) and 90 percent as OTC hearing aids (about 7 products per manufacturer).

The labeling cost model used in the PRIA suggests an annual estimated third-party disclosure burden of about 19 hours per product. We request comments on these estimates and assumptions. Prescription Hearing Aid Labeling—§ 801.422 (Third-Party Disclosure).

Proposed § 801.422(c) sets forth labeling requirements for prescription hearing aids. However, as with some of the provisions under proposed § 800.30(c), we include no estimate for provisions under proposed § 801.422(c)(1)(i)(A) and (B), (c)(2)(i)(A) through (C), and (c)(2)(ii)(A) through (E) because we consider the labeling to be “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public,” consistent with 5 CFR 1320.3(c)(2). Proposed § 801.422(c)(1) provides the warnings that must be on the outside package labeling and, if applicable, that the prescription hearing aid is used or rebuilt.

Proposed § 801.422(c)(2) describes requirements for prescription hearing aid labeling, inside the package. Among the labeling requirements listed are a user instructional brochure, an electronic version of which is to be made available for download. Additional warnings.

Caution and notices for users. And additional information that must be included in the user instructional brochure. Proposed § 801.422(c)(3) provides the requirements for the labeling on a prescription hearing aid itself, specifically, name of the manufacturer, model name or number, serial number, and year of manufacture.

As well as information regarding the battery if applicable. And if the prescription hearing aid is used or rebuilt, the manufacturer must physically attach a removable tag to the hearing aid declaring that fact. Proposed § 800.422(c)(4) provides the technical specification elements that must appear in the user instructional brochure or in separate labeling that accompanies the device.

The PRIA estimates that 105 firms manufacture air conduction hearing aids sold in the United States, based on FDA Medical Device Registration data. We estimate that each manufacturer has an average of eight products that would need relabeling. For each hearing aid product, we assume a 1-hour annual recordkeeping burden for maintaining the electronic version of the user instructional brochure (under proposed §§ 800.30(c)(2) and 801.422(c)(2)).

The proposed rule would necessitate the relabeling of all current hearing aids (approximately 840) according to either the proposed OTC or prescription hearing aid labeling requirements. While we lack specific data regarding what portion of hearing aids will be relabeled as prescription devices and what portion will be relabeled as OTC hearing aids, for this analysis, we assume that 10 percent will be relabeled as prescription medical devices (about 1 product per manufacturer) and 90 percent as OTC hearing aids (about 7 products per manufacturer). The labeling cost model used in the PRIA suggests an annual estimated third-party disclosure burden of about 19 hours per product.

We request comments on these estimates and assumptions. To ensure that comments on information collection are received, OMB recommends that written comments be submitted through https://www.reginfo.gov/​public/​do/​PRAMain (see ADDRESSES ). All comments should be identified with the title of the information collection.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect.

FDA will announce OMB approval of these requirements in the Federal Register. IX. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132.

Section 4(a) of the Executive Order requires Agencies to “construe. . .

A Federal statute to preempt State law only where the statute contains an express preemption provision or where there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from, or in addition to, any requirement applicable under” chapter V of the FD&C Act that is applicable to devices. (See section 521 of the FD&C Act. Medtronic v.

Medtronic, 552 U.S. 312 (2008)). Federal law also preempts State or local laws “specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of [OTC hearing aids] through in-person transactions, by mail, or online, that [are] different from, in addition to, or otherwise not identical to, the regulations promulgated under” section 709(b) of FDARA (see section 709(b)(4) of FDARA).

Section 521(b) of the FD&C Act provides that the Commissioner of Food and Drugs may, upon application of a State or local government, exempt a requirement from preemption, if the State or local requirement for the device is more stringent than the requirement Start Printed Page 58176 under the FD&C Act, or if the requirement is necessitated by compelling local conditions and compliance with it would not cause the device to be in violation of a requirement under the FD&C Act.” Following this process, and if this rule becomes final, a State or local government may request an exemption from preemption for those State or local requirements pertaining to hearing aid products that are preempted by the Agency's final rule under section 521 of the FD&C Act. However, because FDARA does not provide a parallel mechanism to exempt State or local requirements from its express preemption provision, FDA is not considering exemptions under section 709(b)(4) of FDARA for OTC hearing aids. Thus, if this proposed rule is made final, the final rule would create requirements that fall within the scope of section 521 of the FD&C Act and/or section 709(b)(4) of FDARA.

If made final, it would also amend § 801.420 and repeal § 801.421, and such changes would affect many of the decisions on applications for exemption from preemption that were issued in relation to these two regulations under section 521(b) of the FD&C Act, resulting in the removal of the regulations codifying such decisions, as discussed further in section III.I. Above. The scope of preemption of this proposed rule, if finalized, is discussed in more detail in sections III.G through I, above.

X. Consultation and Coordination With Indian Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action. XI. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m.

And 4 p.m., Monday through Friday. They are also available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction.

Some may be available at the website address, if listed. References without asterisks are available for viewing only with the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Ferruci, “Hearing Loss Prevalence in the United States.” Archive of Internal Medicine, 171:1851-1853, 2011. 2. Dalton, D.S., “The Impact of Hearing Loss on Quality of Life in Older Adults.” The Gerontologist, 43(5):661-668, 2005.

National Institute on Deafness and Communication Disorders. 2010. Available at.

Https://www.nidcd.nih.gov/​health/​statistics/​quick-statistics-hearing. 3a. Maharani, A., Dawes, P., et al., “Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans.” Journal of the American Geriatrics Society, 66(6):1130-1136, 2018.

3b. Mahmoudi, E., Basu, T., et al., “Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Americans?. € Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.

Fortnum, “Why Do People Fitted With Hearing Aids Not Wear Them?. € International Journal of Audiology, 52(5):360-368, 2013. *5.

Gudmundsen, G., Citizen Petition, FDA-2003-P-0342. Received August 11, 2003. 6.

NASEM, “Hearing Health Care for Adults. Priorities for Improving Access and Affordability.” Board on Health Sciences Policy, Committee on Accessible and Affordable Hearing Health Care for Adults. Blazer, D.G., S.

Domnitz, and C.T. Liverman, Eds., 2016. DOI.

10.17226/23446. Available at. Https://www.nap.edu/​catalog/​23446/​hearing-health-care-for-adults-priorities-for-improving-access-and.

*7. Executive Office of the President. €œAging America &.

Hearing Loss. Imperative of Improved Hearing Technologies.” PCAST. 2015.

Available at. Https://obamawhitehouse.archives.gov/​sites/​default/​files/​microsites/​ostp/​PCAST/​pcast_​hearing_​tech_​letterreport_​final.pdf. *8.

FDA, “Immediately in Effect Guidance Document. Conditions for Sale for Air-Conduction Hearing Aids.” Guidance for Industry and Food and Drug Administration Staff. December 12, 2016.

Available at. Https://www.fda.gov/​downloads/​medicaldevices/​deviceregulationandguidance/​guidancedocuments/​ucm531995.pdf. *9.

FDA, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” public workshop. Silver Spring, MD. April 21, 2016.

Available at. Https://wayback.archive-it.org/​7993/​20171114234227/​https://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm480336.htm. *10.

Wallhagen, M., “HLAA Response to Call for Comment.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD. April 21, 2016.

Available at. Https://wayback.archive-it.org/​7993/​20171115155122/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497333.pdf. 11.

NASEM, “Over-The-Counter Hearing Devices Discussion. Safety and Quality Requirements and Considerations Session.” MP3, 1:15:39 (English). National Academies' Hearing Health Care Report.

June 2017 Dissemination Meeting. Washington, DC, 2017. *12.

Lintz, J.S., “FDA Testimony.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD. April 21, 2016.

Available at. Https://wayback.archive-it.org/​7993/​20171114234227/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM500626.pdf. 13.

ANSI/CTA 2051. Personal Sound Amplification Performance Criteria (voluntary consensus standard). 2017.

Available at. Https://webstore.ansi.org/​standards/​ansi/​cta20512017ansi. *14.

NIOSH, Occupational Noise Exposure, publication number 98-126. June 1998. Available at.

Https://www.cdc.gov/​niosh/​docs/​98-126/​pdfs/​98-126.pdf. *15. Killion, M.C., “Presentation on the Work of the CTA PSAP Standard Committee.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.

Silver Spring, MD. April 21, 2016. Available at.

Https://wayback.archive-it.org/​7993/​20171115155142/​https://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497364.pdf. *16. Laureyns, M., “The Potential Risk of Using PSAPs.” For Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.

Silver Spring, MD. April 21, 2016. Available at.

Https://wayback.archive-it.org/​7993/​20171115155108/​https:/www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM497406.pdf. 17. Dillon, H., Hearing Aids.

2nd ed. New York, NY. Thieme Publishers, 2012.

18. Kuk, F.K., “Theoretical and Practical Considerations in Compression Hearing Aids.” Trends in Amplification, 1(1):5-39, 1996. *19.

Bose, “Hearing Health and Technology Workshop,” public comment, P171200 #00140, to FTC. Received May 18, 2017. Available at.

Https://www.ftc.gov/​policy/​public-comments/​2017/​05/​18/​comment-00140. 20. Hearing Review, “NASEM Committee Looks at Regulations for OTC Hearing Devices.” June 12, 2017.

Available at. Https://www.hearingreview.com/​2017/​06/​nasem-committee-looks-regulations-otc-hearing-devices/​. 21.

Starkey Hearing Technologies, The Compression Handbook. An Overview of the Characteristics and Applications of Compression Amplification. 4th ed., 2017.

Visit https://starkeypro.com/​pdfs/​The_​Compression_​Handbook.pdf. Start Printed Page 58177 22. Smith, C., L.A.

Wilber, and K. Cavitt, “PSAPs vs Hearing Aids. An Electroacoustic Analysis of Performance and Fitting Capabilities.” Hearing Review, June 14, 2016, 2016.

Available at. Https://www.hearingreview.com/​2016/​06/​psaps-vs-hearing-aids-electroacoustic-analysis-performance-fitting-capabilities/​. *23.

FDA, “Preliminary Regulatory Impact Analysis. Initial Regulatory Flexbility Analysis. Unfunded Mandates Reform Act Analysis.” 2019.

Available at. Https://www.fda.gov/​AboutFDA/​ReportsManualsForms/​Reports/​EconomicAnalyses/​default.htm. Start List of Subjects 21 CFR Part 800 Administrative practice and procedureIncorporation by referenceMedical devicesOphthalmic goods and servicesPackaging and containersReporting and recordkeeping requirements 21 CFR Part 801 Incorporation by referenceLabelingMedical devicesReporting and recordkeeping requirements 21 CFR Part 808 Intergovernmental relationsMedical devices 21 CFR Part 874 Medical devices End List of Subjects Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR parts 800, 801, 808, and 874 be amended as follows.

Start Part End Part Start Amendment Part1. The authority citation for part 800 is revised to read as follows. End Amendment Part Start Authority 21 U.S.C.

321, 334, 351, 352, 355, 360e, 360i, 360j, 360k, 361, 362, 371. End Authority Section 800.30 also issued under Sec. 709, Pub.

Start Amendment Part2. Add § 800.30 to subpart B to read as follows. End Amendment Part Over-the-Counter Hearing Aid Controls.

(a) Scope. This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term.

Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act and do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation. (b) Definitions for the purposes of this section.

This section uses the following definitions. Air-conduction hearing aid. An air-conduction hearing aid is a hearing aid that conducts sound to the ear through the air.

Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Licensed person.

A licensed person is a person as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a license or degree for the diagnosis, assessment, or treatment of hearing loss. Or that holds a license to sell or distribute hearing aids. A person that must meet generally applicable licensing or operating requirements such as annual health and safety inspections, provided the generally applicable licensing or operating requirement is consistent with this section and other applicable requirements under the Federal Food, Drug, and Cosmetic Act, is not a “licensed person” solely for that reason.

A person that represents as a marketer, seller, dispenser, distributor, or customer support representative (or an equivalent description) is not a “licensed person” solely by making such representations. Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid is an air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment.

The device, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. The device may use wireless technology or may include tests for self-assessment of hearing loss. The device is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section.

Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an OTC hearing aid as defined in this section or a hearing aid that does not satisfy the requirements in this section. Sale.

Sale includes a lease, rental, or any other purchase or exchange for value. Tools, tests, or software. Tools, tests, or software are components of the device that, individually or in combination, allow a lay user to control the device and customize it sufficiently, such as the device's output, to meet the user's hearing needs.

Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user.

A hearing aid evaluation is “bona fide” if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination. (c) Labeling. An OTC hearing aid shall bear all of the following in the labeling.

(1) Outside package labeling. The outside package of an OTC hearing aid shall bear all of the following. (i) Warnings and other important information.

All of the following shall appear on the outside package. Start Printed Page 58178 Start Printed Page 58179 (ii) Statement of build condition. If the OTC hearing aid is used or rebuilt, the outside package shall declare that fact.

A sticker under and visible through the outer wrapper will suffice to declare such fact. (2) Labeling, inside the package. The manufacturer or distributor of an OTC hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service.

The user instructional brochure shall include all of the following. (i) The following warnings, which shall appear in the following order and prior to any content except the cover page. Start Printed Page 58180 (ii) Any additional warnings the manufacturer may include prior to the caution and notices to users in paragraph (c)(2)(iii) of this section.

(iii) The following caution and notices for users, which shall appear prior to any content except the cover page and the warnings under paragraphs (c)(2)(i) and (ii) of this section. Start Printed Page 58181 Start Printed Page 58182 (iv) An illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and the battery compartment. (v) Information on the function of all controls intended for user adjustment.

(vi) A description of any accessory that accompanies the OTC hearing aid, including but not limited to wax guards and accessories for use with a computer, television, or telephone. (vii) Specific instructions for all of the following. (A) Instructions for sizing or inserting the eartip of the OTC hearing aid to prevent insertion past the bony-cartilaginous junction of the external auditory canal and damage to the tympanic membrane.

(B) The tools, tests, or software that allow the user to control the OTC hearing aid, including self-select, self-fit, and self-check the performance of the OTC hearing aid, and customize it to the user's hearing needs, including information about properly fitting eartips. (C) Use of the OTC hearing aid with any accompanying accessories. (D) Maintenance and care of the OTC hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time.

(E) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries. (F) Expected battery life. (G) Any other information necessary for adequate directions for use as defined in § 801.5.

(viii) Identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax). (ix) The technical specifications required by paragraph (c)(4) of this section. (x) A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid, including but not limited to ear wax buildup, drops, immersion in water, or exposure to excessive heat.

(xi) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xii) If the manufacturer provides a repair service or licenses or certifies third-party repair services, information on how and where to obtain repair service, including at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service. (xiii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies.

(3) Labeling on the device. The labeling on an OTC hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section. (i) The serial number.

(ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the OTC hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact. (4) Technical specifications.

All of the following technical specifications shall appear in the user instructional brochure that accompanies the device. You may additionally include it on the outside package. (i) The maximum output limit value (OSPL90).

(ii) The full-on gain value, which is the gain with a 50 dB SPL pure-tone input and volume set to full on. (iii) The total harmonic distortion value. (iv) The self-generated noise value.

(v) The latency value. (vi) The upper and lower cutoff frequencies for bandwidth. (d) Output limits.

The output limit for an OTC hearing aid shall be the device maximum acoustic output sound pressure level (SPL) in a 2-cubic centimeter (cm3 ) coupler when the device input is a 90 dB SPL pure-tone, and the gain/volume control is full on. An OTC hearing aid shall not exceed the following limits. (1) General output limit.

An OTC hearing aid shall not exceed an output limit of 115 dB SPL at any frequency except as provided in paragraph (d)(2) of this section. (2) Output limit for a device with input-controlled compression and user-adjustable volume control. An OTC hearing aid that includes input-controlled compression and a user-adjustable volume control shall not exceed an output limit of 120 dB SPL at any frequency.

(e) Electroacoustic performance limits. An OTC hearing aid shall perform within all of the following electroacoustic limits. Measure each electroacoustic performance characteristic using a 2-cm3 coupler where applicable.

(1) Output distortion control limits. Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section. (i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method.

Start Printed Page 58183 (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL. Or (B) Using a 500-Hz one-third-octave pulsed-noise signal, measure at 67 dB SPL and 97 dB SPL. (ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid.

(iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs. (2) Self-generated noise level limits. Self-generated noise shall not exceed 32 dB SPL.

You must disable any methods that artificially lower the apparent noise floor for the measurement. Such methods would include but are not limited to auto-muting and downward expansion. (3) Latency.

Latency shall not exceed 15 ms. You must measure the latency with a method that is accurate and repeatable to within 1.5 ms. (4) Frequency response bandwidth.

The lower cutoff frequency shall extend to 250 Hz or below, and the upper cutoff frequency shall extend to 5 kHz or greater. You must measure the frequency response bandwidth as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (5) Frequency response smoothness.

No single peak in the one-third-octave frequency response shall exceed 12 dB relative to the average levels of the one-third-octave bands, two-thirds octave above and below the peak. You must measure the frequency response smoothness using values for a diffuse field and the corrected one-third-octave frequency insertion response as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (f) Design requirements.

An OTC hearing aid must conform to all of the following design requirements. (1) Insertion depth. The design of an OTC hearing aid shall limit the insertion of the eartip to the bony-cartilaginous junction of the external auditory canal and no deeper.

(2) Use of atraumatic materials. The material for the eartip of an OTC hearing aid shall be atraumatic. (3) Proper physical fit.

The OTC hearing aid shall be designed to enable consumers to readily achieve a safe, customized, acoustically favorable, and comfortable physical fit in the ear canal and/or external ear. (4) Tools, tests, or software. The OTC hearing aid shall, through tools, tests, or software, permit a lay user to control the device and customize it to the user's hearing needs.

(g) Condition for sale of an OTC hearing aid. The sale of an OTC hearing aid to or for a person younger than 18 years of age is prohibited. (h) Effect on State law.

Any State or local government requirement for an OTC hearing aid is preempted to the following extent. (1) Preemption. No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations issued under section 709(b) of the FDA Reauthorization Act of 2017, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids.

(2) Professional requirements. €”(A) General rule. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids, or an equivalent activity, whether through in-person transactions, by mail, or online, shall not cause, require, or otherwise obligate a person providing such services to obtain specialized licensing, certification, or any other State or local sanction unless such requirement is generally applicable to the sale of any product or to all places of business regardless of whether they sell OTC hearing aids.

However, although a State or local government may not require the order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids, a licensed person may service, market, sell, dispense, provide customer support for, or distribute OTC hearing aids. (B) Sale of OTC hearing aids is not an exemption. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids does not exempt a person from any State or local government's professional or establishment requirements that are consistent with this section.

(C) Representations may create professional obligations. A person shall not incur specialized obligations by representing as a servicer, marketer, seller, dispenser, customer support representative, or distributor (or an equivalent description) of OTC hearing aids. However, a person representing as any other defined professional or establishment, or as a State licensed dispenser, is subject to applicable State and local requirements even if the person undertakes commercial or professional activities only in relation to OTC hearing aids.

(3) Private remedies. This section does not modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law. (i) Incorporation by reference.

(A) The standard required in this section is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html.

(B) ANSI. The American National Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 20036, storemanager@ansi.org, https://www.ansi.org, 202-293-8020. ( 1 ) ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” clause 4.1, dated January 2017.

( 2 ) [Reserved] (ii) [Reserved] Start Part End Part Start Amendment Part3. The authority citation for part 801 is revised to read as follows. End Amendment Part Start Authority 21 U.S.C.

321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374. End Authority Start Amendment Part4. Remove § 801.420.

End Amendment Part Start Amendment Part5. Remove § 801.421. End Amendment Part Start Amendment Part6.

Add § 801.422 to subpart H to read as follows. End Amendment Part Prescription hearing aid labeling. (a) Scope.

This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the Start Printed Page 58184 applicable classification regulation.

This section does not apply to group auditory trainers. (b) Definitions for the purposes of this section. This section uses the following definitions.

Dispenser. A dispenser is any person, as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of prescription hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person. Hearing aid.

A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an over-the-counter (OTC) hearing aid as defined in § 800.30 of this chapter or a hearing aid that does not satisfy the requirements in § 800.30 of this chapter.

Sale. Sale includes a lease, rental, or any other purchase or exchange for value. Used hearing aid.

A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is “bona fide” if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination.

(c) Labeling. A prescription hearing aid shall bear all of the following labeling. (1) Outside package labeling.

The outside package of a prescription hearing aid shall bear all of the following. (i) Warnings. All of the following shall appear on the outside package.

Start Printed Page 58185 (B) Statement of build condition. If the prescription hearing aid is used or rebuilt, the outside package shall declare that fact. A sticker under and visible through the outer wrapper will suffice to declare such fact.

(2) Labeling, inside the package. The manufacturer or distributor of a prescription hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service. The user instructional brochure shall include all of the following.

(i) The following warnings, which shall appear in the following order and prior to any content except the cover page. Start Printed Page 58186 Start Printed Page 58187 Start Printed Page 58188 (iii) An illustration(s) of the prescription hearing aid that indicates operating controls, user adjustments, and the battery compartment. Start Printed Page 58189 (iv) Information on the function of all controls intended for user adjustment.

(v) A description of any accessory that accompanies the prescription hearing aid, including but not limited to wax guards, and accessories for use with a computer, television, or telephone. (vi) Specific instructions for all of the following. (A) Use of the prescription hearing aid with any accompanying accessories.

(B) Maintenance and care of the prescription hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time. (C) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries. (D) Expected battery life.

(vii) Identification of any known physiological side effects associated with the use of the prescription hearing aid that may warrant consultation with a physician, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax). (viii) The technical specifications required by paragraph (c)(4) of this section unless such specifications appear in separate labeling accompanying the prescription hearing aid. (ix) A description of commonly occurring, avoidable events that could adversely affect or damage the prescription hearing aid, including but not limited to ear wax buildup, drops, immersion in water, or exposure to excessive heat.

(x) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xi) If the manufacturer provides a repair service or licenses or certifies third-party repair services, information on how and where to obtain repair service, including at least one specific address where the user can go or send the prescription hearing aid to obtain such repair service. (xii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the prescription hearing aid, a summary of all such studies.

(3) Labeling on the device. The labeling on a prescription hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section. (i) The serial number.

(ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the prescription hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact. (4) Technical specifications.

Technical specifications useful in selecting, fitting, and checking the performance of the prescription hearing aid shall appear in the user instructional brochure or in separate labeling that accompanies the device. You must determine the technical specification values for the prescription hearing aid labeling in accordance with the test procedures of the American National Standard, “Specification of Hearing Aid Characteristics,” ANSI/ASA S3.22-2014. As a minimum, the user instructional brochure or such other labeling shall include the appropriate values or information for the following technical specification elements as these elements are defined or used in such standard.

(i) Saturation output curve (SSPL 90 curve). (ii) Frequency response curve. (iii) Average saturation output (HF-Average SSPL 90).

(iv) Average full-on gain (HF-Average full-on gain). (v) Reference test gain. (vi) Frequency range.

(vii) Total harmonic distortion. (viii) Equivalent input noise. (ix) Battery current drain.

(x) Induction coil sensitivity (telephone coil aids only). (xi) Input-output curve (only for hearing aids with automatic gain control). (xii) Attack and release times (only for hearing aids with automatic gain control).

(5) Misbranding. A prescription hearing aid that is not labeled as required under this section and § 801.109 of this chapter shall be misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and Cosmetic Act. (d) Incorporation by reference.

(1) The standard required in this section is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html..

(2) ANSI. The American National Standards Institute, 1889 L Street NW, 11th Floor, Washington, DC 20036, storemanager@ansi.org, https://www.ansi.org, 202-293-8020. (i) ANSI/ASA S3.22-2014, “Specification of Hearing Aid Characteristics,” dated November 2014.

(ii) [Reserved] Start Part End Part Start Amendment Part7. The authority citation for part 808 is revised to read as follows. End Amendment Part Start Authority 21 U.S.C.

360j, 360k, 371. End Authority Section 808.1 also issued under Sec. 709, Pub.

Start Part End Part Start Amendment Part8. In part 808, remove the words “the act” and add in their place “the Federal Food, Drug, and Cosmetic Act”. End Amendment Part Start Amendment Part9.

In § 808.1, add headings to paragraphs (a) through (f) and add paragraph (g) to read as follows. End Amendment Part Scope. (a) Introduction.

* * * (b) General rule for State and local requirements respecting devices. * * * (c) Exempting from preemption certain State or local requirements respecting devices. * * * (d) Meaning of “requirements applicable to a device.” * * * (e) Determination of equivalence or difference of requirements applicable to a device.

* * * (f) Applicability of Federal requirements respecting devices. * * * (g) Exemptions not applicable to certain State or local government requirements specifically related to hearing products. An exemption under this part shall not apply to any State or local government law, regulation, order, or other requirement specifically related to hearing products, including any requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids, that.

(1) Would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of Start Printed Page 58190 over-the-counter hearing aids, as defined under section 520(q) of the Federal Food, Drug, and Cosmetic Act, through in-person transactions, by mail, or online. And (2) Is different from, in addition to, or otherwise not identical to, the regulations issued under section 709(b) of the FDA Reauthorization Act of 2017. Start Amendment Part10.

Revise § 808.3 to read as follows. End Amendment Part Definitions. Compelling local conditions includes any factors, considerations, or circumstances prevailing in, or characteristic of, the geographic area or population of the State or political subdivision that justify exemption from preemption.

More stringent refers to a requirement of greater restrictiveness or one that is expected to afford to those who may be exposed to a risk of injury from a device a higher degree of protection than is afforded by a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act. Political subdivision or locality means any lawfully established local governmental unit within a State which unit has the authority to establish or continue in effect any requirement having the force and effect of law with respect to a device intended for human use. State means any State or Territory of the United States, including but not limited to, the District of Columbia and the Commonwealth of Puerto Rico.

Substantially identical to refers to the fact that a State or local requirement does not significantly differ in effect from a Federal requirement. [Removed and Reserved] Start Amendment Part11. Remove and reserve § 808.53.

End Amendment Part Start Amendment Part12. Revise § 808.55 to read as follows. End Amendment Part California.

The following California medical device requirements are preempted under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and FDA has denied them exemption from preemption. (a) Medical devices. General provisions.

Sherman Food, Drug, and Cosmetic Law, Division 21 of the California Health and Safety Code, sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to the extent that they apply to devices. And (b) Ophthalmic devices. Quality standards.

California Business and Professions Code, section 2541.3 to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2. [Removed and Reserved] Start Amendment Part13. Remove and reserve §§ 808.57 through 808.101.

End Amendment Part Start Part End Part Start Amendment Part14. The authority citation for part 874 continues to read as follows. End Amendment Part Start Authority 21 U.S.C.

351, 360, 360c, 360e, 360j, 360l, 371. End Authority Start Amendment Part15. Redesignate § 874.3300 as § 874.3301 and revise to read as follows.

End Amendment Part Bone-conduction hearing aid. (a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that transmits sound to the inner ear through the skull.

A bone-conduction hearing aid is subject to the requirements in § 801.422 of this chapter. (b) Classification. Class II.

Start Amendment Part16. Revise § 874.3305 to read as follows. End Amendment Part Air-conduction hearing aid.

(a) Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid may be wireless, self-fitting, or both.

An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. Air-conduction hearing aid generic types exclude the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively. (b) Classification.

(1) Legacy hearing aid. Class I for an air-conduction hearing aid that is not a wireless or self-fitting device. This hearing aid is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

(2) Wireless hearing aid. Class II (special controls) for an air-conduction hearing aid that incorporates wireless technology in its programming or use. A wireless hearing aid may also be a self-fitting hearing aid.

A wireless hearing aid that is not a self-fitting hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. The special controls for a wireless hearing aid are. (i) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.

(ii) Performance testing must validate safety of exposure to non-ionizing radiation. And (iii) Performance data must validate wireless technology functions. (3) Self-fitting hearing aid.

Class II (special controls) for a wireless air-conduction hearing aid that incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fittings and settings. A self-fitting hearing aid is not exempt from premarket notification procedures, notwithstanding the exemption in paragraph (b)(2) of this section.

The special controls for a self-fitting hearing aid, in addition to the special controls for a wireless hearing aid if the device incorporates wireless technology, are. (i) Clinical data must evaluate the effectiveness of the self-fitting strategy. (ii) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.

(iii) Software verification, validation, and hazard analysis must be performed. And (iv) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. Start Amendment Part17.

In § 874.3315, revise paragraph (a) to read as follows. End Amendment Part Tympanic membrane contact hearing aid. (a) Identification.

A tympanic membrane contact hearing aid is a prescription wearable device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. A tympanic membrane contact hearing aid is subject to the requirements in § 801.422 of this chapter.

* * * * * Start Printed Page 58191 [Removed] Start Amendment Part18. Remove § 874.3325. End Amendment Part Start Amendment Part19.

In § 874.3950, add a sentence at the end of paragraph (a) to read as follows. End Amendment Part Transcutaneous air conduction hearing aid system. (a) * * * A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter.

* * * * * Start Signature Dated. October 8, 2021. Janet Woodcock, Acting Commissioner of Food and Drugs.

End Signature End Supplemental Information BILLING CODE 4164-01-PBILLING CODE 4164-01-PBILLING CODE 4164-01-C[FR Doc. 2021-22473 Filed 10-19-21. 8:45 am]BILLING CODE 4164-01-P.

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Www.digitalhealth.gov.auMedia release - Electronic prescriptions roll out expands to Metropolitan Sydney.pdf.

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Please refer to the NCTS Document Library Release Note v2.24 in Recent how much lasix cost Updates for further details EventsAMT Support Group meetingThe AMT Support Group is an open forum to provide an opportunity for individuals to participate in the ongoing development of the AMT. The next meeting will be held via teleconference on Tuesday 10th November 2:00-3:30pm (AEDT). If you are not yet a member and keen to be involved, please forward an expression of interest to [email protected].EducationSNOMED course catalogueSNOMED International has launched two new short courses as part how much lasix cost of their suite of education courses and learning pathways.SNOMED CT for Clinicians is a short course that introduces SNOMED CT to clinicians and answers some of the questions commonly asked.

This is currently offered for free.SNOMED CT Terminology Services Certification Course is a self-paced course that teaches the principles of using a SNOMED CT terminology server to search and retrieve SNOMED CT content. The price for Australian individuals is $US100.Want how much lasix cost to know more?. Visit the SNOMED CT course catalogue for information and to enrol in these and other courses on offer.

Https://courses.ihtsdotools.org/SNOMED CT Foundation Course^ - FREE for Australian individuals and is a prerequisite for some of the other courses.SNOMED CT Authoring Level 1 Course^ - New intakes begin every March and September.SNOMED CT Authoring Level 1 Certification.SNOMED CT Implementation Course^ - New intakes begin every January and July.SNOMED CT for Data Analysts - FREE.SNOMED how much lasix cost CT for Developers - FREE.^These courses also earn you CPD points towards your Certified Health Informatician Australasia (CHIA) credentials.LicensingSNOMED CT-AU inclusive of the Australian Medicines Terminology is updated monthly and is available to download for free to registered license holders. To register for an account please go to the registration page.Licensing terms can be found here.FeedbackDevelopment by the NCTS relies on the input and how much lasix cost cooperation of the Australian healthcare community. We value your feedback and encourage questions, comments, or suggestions about our products.

You can contact us by completing the online support request form, emailing [email protected], or calling 1300 901 001.Thank you for your continued support.21 how much lasix cost October, 2020. Sydney’s five million residents will soon have access to electronic prescriptions, including communities from Hornsby shire in the north, to the city of Campbelltown in the south and the city of Penrith in the west. This follows the roll out across all how much lasix cost of Victoria in September.

If a patient wants an electronic prescription from their doctor, rather than a paper prescription, the doctor selects this option in their software when creating the prescription and the patient will immediately receive an SMS or email. The patient then sends or takes this to their preferred pharmacy.The SMS or email contains a QR code how much lasix cost ‘token’ that unlocks the electronic prescription from a secure, encrypted electronic prescription delivery service. Once scanned, the token allows the pharmacist to view the prescription and dispense the medicine.Australian Digital Health Agency CEO Amanda Cattermole said, “There has been significant uptake of electronic prescriptions since they were first made available in May.

Since then, nearly 400,000 electronic how much lasix cost prescriptions have been received by patients.”Victoria already has access to electronic prescriptions and Sydney will roll out this month, followed by a staged expansion across the rest of Australia.To prepare for electronic prescriptions, more than 13,000 healthcare providers have attended online training and education sessions run by the Agency. Further support and advice has been provided by clinical peak bodies, including the Royal Australian College of General Practitioners (RACGP), the Australian College of Rural and Remote Medicine (ACRRM), the Pharmacy Guild of Australia (PGA) and the Pharmaceutical Society of Australia (PSA). Software providers have also provided masterclasses to their health professional customers.This collaboration means that when electronic prescriptions are available in your community, doctors and pharmacists will be prepared and able to support their patients.Western how much lasix cost Sydney pharmacy owner and NSW Pharmacy Guild and National Councillor Catherine Bronger said, “Community pharmacies across Sydney have been working to upgrade their dispensing software and review their in-pharmacy workflow to get ready for electronic prescriptions.

The Guild looks forward to further releases of electronic prescriptions functionality providing more convenience for patients, especially those who are on multiple medicines.” Future software enhancements in 2020 include the Active Script List (ASL), which is a token management solution.Electronic prescriptions are how much lasix cost an alternative to paper prescriptions. People should check if their preferred pharmacy is ready to dispense electronic prescriptions before requesting an electronic prescription from their doctor. For further details on electronic prescribing in NSW, here.For a summary of how much lasix cost all legal forms of prescriptions in NSW, here.Media contactAustralian Digital Health Agency Media TeamMobile.

0428 772 421Email. [email protected] About the Australian Digital Health AgencyThe Agency is tasked with improving health outcomes for all Australians through the delivery how much lasix cost of digital healthcare systems, and implementing Australia’s National Digital Health Strategy – Safe, Seamless, and Secure. Evolving health and care to meet the needs of modern Australia in collaboration with partners across the community.

The Agency is how much lasix cost the System Operator of My Health Record, and provides leadership, coordination, and delivery of a collaborative and innovative approach to utilising technology to support and enhance a clinically safe and connected national health system. These improvements will give individuals more control of their health and their health information, and support healthcare providers to deliver informed healthcare through access to current clinical and treatment information. Further information how much lasix cost.

Www.digitalhealth.gov.auMedia release - Electronic prescriptions roll out expands to Metropolitan Sydney.pdf.

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But practice buy lasix online overnight delivery is better than avoidance. Using headphones or by streaming sounddirectly to your hearing aids, you can listento audiobooks and hone your hearing andlistening skills. Auditory training programs offer exercises designed to improve your hearing skills. You may be a candidate for auditory training if you’re getting a hearing aid for the buy lasix online overnight delivery first time or have trouble understanding speech despite normal hearing, a condition called “hidden hearing loss.” Specialized programs and smartphone apps have been designed with the feel of a video game. But if you like stories and dramatic voices, consider audiobooks as well.

They are a unique way to enjoy literature and you can sharpen your hearing comprehension at the same time. Hearing isn’t just about recognizing sounds buy lasix online overnight delivery. We need to interpret them. Audiobooks can help us exercise “those linguistic areas of your brain that are crucial for comprehension” explains Nancy Tye-Murray, AuD, and professor at Washington University School of Medicine. You can also use them to practice listening to foreign accents or multiple voices while you’re not under social pressure—with the magical power to buy lasix online overnight delivery rewind anytime!.

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I’m also a fan of subtitles while watching buy lasix online overnight delivery television or movies. If you’re the same way, you might get an audiobook of a paper book you’ve read before and own. See how it feels to read and listen simultaneously—without also tracking all the visual information in a movie. It’s best to start in a quiet room with a buy lasix online overnight delivery book narrated by a male voice, says Tye-Murray, who has created an online auditory training program Amptify. Lower pitches are usually easier to hear.

An accomplished actor is your best bet. Find a buy lasix online overnight delivery voice you enjoy—you have lots of options!. Play your first audiobook at a slower than normal speed, if that helps you, while following the text. Over time you can change the speed to the normal setting. Next, she advises, buy lasix online overnight delivery try listening without reading along at the slower speed “until you’re comfortable with changing to normal speed.” “Start really paying attention to how much you comprehend,” she said.

€œAfter you finish listening to a chapter, you might jot down a few sentences that capture the essence of the chapter (for example, ‘Janey Smith caught the bus and ended up sitting next to a tall, dark stranger.’)” This will reinforce your brain’s comprehension muscles. You might also go back and read each chapter and keep records on how much you understood while listening. For your second book, you might choose one narrated by buy lasix online overnight delivery a woman and repeat the steps above. You might want to listen only for 20 minutes to a half hour at first. Listening can be tiring.

Also, remember that if you lose your place you can always rewind buy lasix online overnight delivery. I tend to fall asleep when I read in the evening, and for me, audiobooks are a good way to stay awake. Top audiobooks for auditory rehab For beginners, Lynn A. Wood, an audiologist in Wheaton, Illinois recommends the buy lasix online overnight delivery children’s book, Oh the Places You’ll Go by Dr. Seuss, read by actor John Lithgow.

For a step up in difficulty, try a young-adult story about a girl and her beloved dog, Because of Winn-Dixie by Kate DiCamillo, read by Cherry Jones, who you might recognize from “The Handmaid’s Tale.” Eventually you’ll be ready to practice listening to people with different accents. If you’re planning a trip to London, try listening to a British novel buy lasix online overnight delivery read by Juliet Stevenson, a British actress you might have seen in “One of Us.” If you’d prefer a classic, consider Little Dorrit, her Dickens collection. She also narrates much-beloved books by Jane Austen and Virginia Woolf. For a recent book with a bit of a meta-fiction twist, try Sweet Tooth by Ian McEwan. You can catch buy lasix online overnight delivery up on classics with sentences and paragraphs that might seem too long on the page.

BBC offers 20 unabridged classics online, including Wuthering Heights, by Emily Bronte, and Henry James’ The Turn of the Screw. New audiobooks draw top talent–you can hear Meryl Streep narrating Charlotte’s Web or Michelle Obama reading all 19 hours of her own memoir, Becoming. Listening to buy lasix online overnight delivery authors narrate their own books can be especially intimate, Jennifer Reese, who reviews audiobooks for The New York Times, told me. She has listened to Patti Smith’s memoirs “multiple times,” she said, “I particularly love her narration of M train.” If you’re feeling really ambitious Try George Saunders’ Lincoln in the Bardo (it made me cry at the end), with 166 narrators. Another book with multiple narrators is The Only Plane in The Sky, Garrett Graff’s oral history of 9/11.

You’ll hear buy lasix online overnight delivery raw audio footage from that day and some of the real people who describe their experiences. A few books have special effects. The Lost Words, a collection of poems about words that have disappeared from dictionaries, includes a soundtrack drawn from the British countryside beneath each poem. Poetry should always be read out loud, though I need a written version in front of me buy lasix online overnight delivery as well. Make this project a way to enjoy books you’ve had on your list but didn’t get to, books that feel like guilty pleasures, and books that pleasurably stretch your listening skills.Having a smoke detector in place is a simple, hugely effective strategy to prevent yourself from harm.

Your risk of dying in a fire in your home falls by 55 percent when there’s a working smoke alarm present, per the National Fire Protection Association (NFPA). People with buy lasix online overnight delivery hearing loss may not be ableto hear standard smoke detector alarms.(Photo courtesy FEMA) And for many people, the attention-grabbing blare of a fire alarm is all you need. If you have impaired hearing, though, the din of these life-saving devices may not be an effective alert to the presence of smoke, fire or carbon monoxide. Alarms with flashing lights, as well as special vibrating alarms designed to wake someone who’s sleeping, are available for people who are deaf or have a hearing impairment. Here’s what you need to know to ensure you have an alarm that provides you with the alert you need buy lasix online overnight delivery.

Why it matters “Today more than ever, it’s important for residents to have the earliest possible notification of an emergency,” says Sharon Cooksey, a fire safety educator at Kidde, an alarm manufacturer. That’s because escape time is lower now than previously needed—just two to three minutes—due to more fast-burning synthetic materials in homes, she says. €œThis makes buy lasix online overnight delivery a quick evacuation a top priority,” Cooksey notes. People at the highest risk of being harmed or dying in a fire include children, people who are under the influence of drugs/alcohol, and people with hearing loss, statistics show. Choose a smoke alarm that’s suitable for your hearing loss If you have high-frequency sensorineural hearing loss due to either age or noise exposure, an ordinary alarm may not give you the alert you need, says audiologist Rich Panelli of Nevada ENT.

“The risk of a normal alarm is that some produce only a high-frequency sound, and some do not produce an alarm loud enough for [people with] a severe to profound buy lasix online overnight delivery hearing loss to pick up,” Panelli says. This is particularly significant at night, when people are likely to remove their hearing aids. “NFPA advises that older adults or other people who are hard of hearing (those with mild to severe hearing loss) can use a device that emits a mixed, low-pitched sound,” Cooksey says. Smoke alarms when buy lasix online overnight delivery you're hard of hearing. Options There are a few different options available, including.

Strobe lights. Instead of buy lasix online overnight delivery relying simply on sound, the flash from strobe alarms gives a visual cue about dangers. If you’re counting on a strobe alarm for nighttime, when you might be asleep, look for one that has an intensity high enough to wake someone up, advises the NFPA. And be aware that older adults may be less responsive to strobe alarms, Cooksey points out. Vibration buy lasix online overnight delivery.

Sleeping is a particularly high-risk time when it comes to fires. Fires during sleeping hours, between 11 p.m. And 7 buy lasix online overnight delivery a.m. Account for 47 percent of fatal fires in residences, according to FEMA. Alarms that make the pillow or bed vibrate (often referred to as “bed shakers”) help wake people up.

Interconnected buy lasix online overnight delivery alarms. €œAlarms that cater to someone with severe to profound hearing loss include a combination of alerting devices, usually in one system,” Panelli says. With this system, when one alarm goes off, all of them do—the bed shakes, lights flash, sounds blare, and so on. Smart advice from FEMA buy lasix online overnight delivery. Whichever alarm system you select, make sure everyone in the house knows what signal (whether it’s light, sound, vibration, or a combo) to expect, Cooksey recommends.

What to look for in alarms for people with hearing loss It can be helpful to connect with your hearing specialist to ask what type of alarm they believe is best-suited for your particular type of hearing loss. €œWhen considering alerting systems, it is important buy lasix online overnight delivery to remember every patient is unique,” Panelli says. Here’s what else to keep in mind when it comes to fire alarms. You need more than one. If you have several floors, you’ll buy lasix online overnight delivery need an alarm in each level (except for the attic), Cooksey says.

Make sure to have one in every bedroom, she says. You’ll need to test them regularly. That way, you’ll know the alarm buy lasix online overnight delivery is working. Cooksey recommends a weekly test. Make sure the alarm is reputable.

€œAlways look for alarms that have the label of a recognized testing laboratory, such as UL,” Cooksey recommends. You’ll find alarms that meet the UL standards for people who are deaf or hard of hearing from BRK Electronics, Gentex Corporation, Kidde Fire Safety, and Menards, Inc., notes the NFPA. Note. This guidance is for households. People who own businesses like hotels must follow ADA laws.

CO detectors for people with hearing loss Carbon monoxide, or CO, is a colorless, odorless gas produced from fossil-burning fuels used in furnaces, boilers, water heaters and fireplaces. Depending upon where you live, state or city laws may require you to have a working CO detector installed in your home. Even if they don't, it's a good idea to have one. Experts recommend installing a CO detector at least 15 feet from the entrance of each bedroom as well as one on every level of your home. Much like smoke alarms for individuals with hearing loss, carbon monoxide detectors are available with strobe lights and vibrating devices.

NFPA codes also apply to these devices, which means these appliances must emit a loud, low-frequency signal. For more information, see the NFPA's page on fire safety and hearing loss..

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But practice is better how much lasix cost than avoidance. Using headphones or by streaming sounddirectly to your hearing aids, you can listento audiobooks and hone your hearing andlistening skills. Auditory training programs offer exercises designed to improve your hearing skills. You may be a candidate for auditory training if you’re getting a hearing aid for how much lasix cost the first time or have trouble understanding speech despite normal hearing, a condition called “hidden hearing loss.” Specialized programs and smartphone apps have been designed with the feel of a video game. But if you like stories and dramatic voices, consider audiobooks as well.

They are a unique way to enjoy literature and you can sharpen your hearing comprehension at the same time. Hearing isn’t just how much lasix cost about recognizing sounds. We need to interpret them. Audiobooks can help us exercise “those linguistic areas of your brain that are crucial for comprehension” explains Nancy Tye-Murray, AuD, and professor at Washington University School of Medicine. You can also use them to practice listening to foreign how much lasix cost accents or multiple voices while you’re not under social pressure—with the magical power to rewind anytime!.

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I’m also a fan of subtitles while watching television or how much lasix cost movies. If you’re the same way, you might get an audiobook of a paper book you’ve read before and own. See how it feels to read and listen simultaneously—without also tracking all the visual information in a movie. It’s best to start in a quiet room with a book narrated by a male voice, says Tye-Murray, who has created how much lasix cost an online auditory training program Amptify. Lower pitches are usually easier to hear.

An accomplished actor is your best bet. Find a voice you enjoy—you have lots how much lasix cost of options!. Play your first audiobook at a slower than normal speed, if that helps you, while following the text. Over time you can change the speed to the normal setting. Next, she advises, try listening without reading along at the slower speed “until you’re comfortable with changing to normal speed.” “Start really paying attention to how how much lasix cost much you comprehend,” she said.

€œAfter you finish listening to a chapter, you might jot down a few sentences that capture the essence of the chapter (for example, ‘Janey Smith caught the bus and ended up sitting next to a tall, dark stranger.’)” This will reinforce your brain’s comprehension muscles. You might also go back and read each chapter and keep records on how much you understood while listening. For your second book, you might choose one narrated by a how much lasix cost woman and repeat the steps above. You might want to listen only for 20 minutes to a half hour at first. Listening can be tiring.

Also, remember how much lasix cost that if you lose your place you can always rewind. I tend to fall asleep when I read in the evening, and for me, audiobooks are a good way to stay awake. Top audiobooks for auditory rehab For beginners, Lynn A. Wood, an audiologist in Wheaton, Illinois recommends the children’s book, Oh the Places You’ll Go how much lasix cost by Dr. Seuss, read by actor John Lithgow.

For a step up in difficulty, try a young-adult story about a girl and her beloved dog, Because of Winn-Dixie by Kate DiCamillo, read by Cherry Jones, who you might recognize from “The Handmaid’s Tale.” Eventually you’ll be ready to practice listening to people with different accents. If you’re planning a trip to London, try how much lasix cost listening to a British novel read by Juliet Stevenson, a British actress you might have seen in “One of Us.” If you’d prefer a classic, consider Little Dorrit, her Dickens collection. She also narrates much-beloved books by Jane Austen and Virginia Woolf. For a recent book with a bit of a meta-fiction twist, try Sweet Tooth by Ian McEwan. You can catch up on classics with sentences and paragraphs that might seem how much lasix cost too long on the page.

BBC offers 20 unabridged classics online, including Wuthering Heights, by Emily Bronte, and Henry James’ The Turn of the Screw. New audiobooks draw top talent–you can hear Meryl Streep narrating Charlotte’s Web or Michelle Obama reading all 19 hours of her own memoir, Becoming. Listening to authors narrate their own books can be especially intimate, Jennifer Reese, who reviews audiobooks for The New York Times, told how much lasix cost me. She has listened to Patti Smith’s memoirs “multiple times,” she said, “I particularly love her narration of M train.” If you’re feeling really ambitious Try George Saunders’ Lincoln in the Bardo (it made me cry at the end), with 166 narrators. Another book with multiple narrators is The Only Plane in The Sky, Garrett Graff’s oral history of 9/11.

You’ll hear raw how much lasix cost audio footage from that day and some of the real people who describe their experiences. A few books have special effects. The Lost Words, a collection of poems about words that have disappeared from dictionaries, includes a soundtrack drawn from the British countryside beneath each poem. Poetry should always be read out loud, though I need a how much lasix cost written version in front of me as well. Make this project a way to enjoy books you’ve had on your list but didn’t get to, books that feel like guilty pleasures, and books that pleasurably stretch your listening skills.Having a smoke detector in place is a simple, hugely effective strategy to prevent yourself from harm.

Your risk of dying in a fire in your home falls by 55 percent when there’s a working smoke alarm present, per the National Fire Protection Association (NFPA). People with hearing loss how much lasix cost may not be ableto hear standard smoke detector alarms.(Photo courtesy FEMA) And for many people, the attention-grabbing blare of a fire alarm is all you need. If you have impaired hearing, though, the din of these life-saving devices may not be an effective alert to the presence of smoke, fire or carbon monoxide. Alarms with flashing lights, as well as special vibrating alarms designed to wake someone who’s sleeping, are available for people who are deaf or have a hearing impairment. Here’s what you need to know to ensure you have an alarm that provides you with the how much lasix cost alert you need.

Why it matters “Today more than ever, it’s important for residents to have the earliest possible notification of an emergency,” says Sharon Cooksey, a fire safety educator at Kidde, an alarm manufacturer. That’s because escape time is lower now than previously needed—just two to three minutes—due to more fast-burning synthetic materials in homes, she says. €œThis makes a quick evacuation how much lasix cost a top priority,” Cooksey notes. People at the highest risk of being harmed or dying in a fire include children, people who are under the influence of drugs/alcohol, and people with hearing loss, statistics show. Choose a smoke alarm that’s suitable for your hearing loss If you have high-frequency sensorineural hearing loss due to either age or noise exposure, an ordinary alarm may not give you the alert you need, says audiologist Rich Panelli of Nevada ENT.

“The risk of how much lasix cost a normal alarm is that some produce only a high-frequency sound, and some do not produce an alarm loud enough for [people with] a severe to profound hearing loss to pick up,” Panelli says. This is particularly significant at night, when people are likely to remove their hearing aids. “NFPA advises that older adults or other people who are hard of hearing (those with mild to severe hearing loss) can use a device that emits a mixed, low-pitched sound,” Cooksey says. Smoke alarms when you're how much lasix cost hard of hearing. Options There are a few different options available, including.

Strobe lights. Instead of relying simply on sound, the flash from strobe alarms gives a how much lasix cost visual cue about dangers. If you’re counting on a strobe alarm for nighttime, when you might be asleep, look for one that has an intensity high enough to wake someone up, advises the NFPA. And be aware that older adults may be less responsive to strobe alarms, Cooksey points out. Vibration how much lasix cost.

Sleeping is a particularly high-risk time when it comes to fires. Fires during sleeping hours, between 11 p.m. And 7 a.m how much lasix cost. Account for 47 percent of fatal fires in residences, according to FEMA. Alarms that make the pillow or bed vibrate (often referred to as “bed shakers”) help wake people up.

Interconnected how much lasix cost alarms. €œAlarms that cater to someone with severe to profound hearing loss include a combination of alerting devices, usually in one system,” Panelli says. With this system, when one alarm goes off, all of them do—the bed shakes, lights flash, sounds blare, and so on. Smart advice from how much lasix cost FEMA. Whichever alarm system you select, make sure everyone in the house knows what signal (whether it’s light, sound, vibration, or a combo) to expect, Cooksey recommends.

What to look for in alarms for people with hearing loss It can be helpful to connect with your hearing specialist to ask what type of alarm they believe is best-suited for your particular type of hearing loss. €œWhen considering how much lasix cost alerting systems, it is important to remember every patient is unique,” Panelli says. Here’s what else to keep in mind when it comes to fire alarms. You need more than one. If you have several floors, you’ll need an how much lasix cost alarm in each level (except for the attic), Cooksey says.

Make sure to have one in every bedroom, she says. You’ll need to test them regularly. That way, how much lasix cost you’ll know the alarm is working. Cooksey recommends a weekly test. Make sure the alarm is reputable.

€œAlways look for alarms that have how much lasix cost the label of a recognized testing laboratory, such as UL,” Cooksey recommends. You’ll find alarms that meet the UL standards for people who are deaf or hard of hearing from BRK Electronics, Gentex Corporation, Kidde Fire Safety, and Menards, Inc., notes the NFPA. Note. This guidance is for households. People who own businesses like hotels must follow ADA laws.

CO detectors for people with hearing loss Carbon monoxide, or CO, is a colorless, odorless gas produced from fossil-burning fuels used in furnaces, boilers, water heaters and fireplaces. Depending upon where you live, state or city laws may require you to have a working CO detector installed in your home. Even if they don't, it's a good idea to have one. Experts recommend installing a CO detector at least 15 feet from the entrance of each bedroom as well as one on every level of your home. Much like smoke alarms for individuals with hearing loss, carbon monoxide detectors are available with strobe lights and vibrating devices.

NFPA codes also apply to these devices, which means these appliances must emit a loud, low-frequency signal. For more information, see the NFPA's page on fire safety and hearing loss..