Over-the-Counter Hearing Aid Act of 2017 explained

Shorttitle:Over the Counter Hearing Aid Act of 2017
Longtitle:FDA Reauthorization Act of 2017 SEC. 709. Regulation of Over-the-Counter Hearing Aids.
Colloquialacronym:OTC Hearing Aid Act
Enacted By:115th
Effective Date:August 18, 2017
Public Law Url:https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf
Cite Public Law:115-52 Sec 709
Acts Amended:Federal Food, Drug and Cosmetic Act
Title Amended:21 U.S.C.: Food and Drugs
Leghisturl:https://www.congress.gov/bill/115th-congress/house-bill/2430/actions?KWICView=false
Introducedin:House and Senate
Introducedbill:,, and
Introducedby:Joe Kennedy III (DMA), Elizabeth Warren (DMA), Greg Walden (R–OR)
Introduceddate:March 21, 2017; May 16, 2017
Committees:United States House Energy Subcommittee on Health, United States Senate Committee on Health, Education, Labor and Pensions; incorporated as rider on the FDA Reauthorization Act of 2017
Passedbody1:House
Passeddate1:July 12, 2017
Passedvote1:passed without objection
Passedbody2:Senate
Passeddate2:August 3, 2017
Passedvote2:passed voice vote
Signedpresident:Donald Trump
Signeddate:August 18, 2017

The Over-the-Counter Hearing Aid Act of 2017 (OTC Hearing Aid Act) was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional (like an audiologist, otolaryngologist, or audiometrist).[1] Regulations for this new class of hearing aid are expected to be released by the end of 2020.

History

Hearing loss affects approximately 466 million individuals worldwide and is most concentrated among older adults.[2] Approximately half of adults in the US age 60+ have some degree of hearing loss.[3] Despite hearing loss' impact on communication, social functioning, and economic productivity across the life course, hearing aid uptake is no higher than 50% - even in settings where costs are covered by insurance.[4] Barriers to addressing hearing loss in the U.S. include stigma, financial costs, and navigating a confusing array of healthcare providers and products to diagnose and treat hearing impairment. In the years leading up to the OTC Hearing Aid Act, the U.S. Institute of Medicine, U.S. National Academies of Science, Engineering and Medicine, President's Council of Advisors on Science and Technology, and U.S. Federal Trade Commission convened committees and workshops examining interventions to increase awareness of hearing loss as a public health problem, and improve access to acceptable, safe, and effective treatment options. From these workshops, allowing direct sale of regulated hearing aids produced by consumer electronics companies emerged as a strategy to promote increased access to hearing loss treatments.[5] [6] [7] In March 2017, Representative Joe Kennedy III (DMA) and Senator Elizabeth Warren (DMA) introduced Over-the-Counter Hearing Aid bills in the U.S. House of Representatives and Senate, respectively.[8] [9] These bills were incorporated into the FDA Reauthorization Act of 2017 which was ratified in August 2017.

Provisions

The law defined the newly created category of OTC hearing aids as devices using air conduction and/or wireless air conduction to improve hearing among adults with "perceived mild to moderate hearing impairment." Devices that modify or amplify sound for people with normal hearing (like noise-cancelling headphones or game ears) are not classified as OTC hearing aids. To ensure safety and effectiveness, the FDA was charged with developing functional guidelines; labeling and marketing standards; and conditions of sale. The Act required the U.S. Department of Health and Human Services to document adverse events associated with OTC hearing aids. The FDA was further tasked with implementing rules regarding the extent of pre-marketing approval required before OTC hearing aids can be sold commercially.

Implementation

In October 2018, the FDA approved the first regulated direct-to-consumer hearing aid, the Bose Hearing Aid, under de-novo premarket review pathway provisions established in the Food and Drug Administration Modernization Act of 1997 and 21st Century Cures Act; regulations under the OTC Hearing Aid Act were not yet published.[10] [11] One year later, the FDA deemed certain Class I and Class II hearing aid-related diagnostic tests and devices exempt from 510(k) pre-market notification requirements.[12] The entry of additional regulated OTC hearing aids, and evaluation of adverse events associated with these devices were to be forthcoming. Regulations for the new class of hearing aid were originally supposed to be released by August 2020, but the FDA delayed them reportedly due to efforts focusing on COVID-19. The new deadline for the release of regulations was expected to be the end of 2020.[13]

Reception

The OTC Hearing Aid Act provisions were met with both support and concern regarding their effects on consumer safety, patient care, and hearing-related professions. Some advocacy organizations, consumer electronics companies, and trade organizations supported the Act, citing telehealth advances,[14] competitive pricing, and recent device improvements as opportunities[15] to widen access to hearing loss treatments.[16] [17] At the same time, the absence of a clear regulatory pathway detailing manufacturing, safety, and effectiveness standards for OTC hearing aids was raised as a barrier to successful roll-out of OTC hearing devices.[18] [19]

Detractors maintained that the current unmet need in hearing loss treatments will not be met by regulating OTC hearing devices.[20] Members of the public and hearing-related professional organizations expressed concerns over the prudence of creating a potentially sub-par class of devices in the absence of evidenced-based practices in patient-directed diagnosis and treatment.[21] [22] [23] Critics also charged that given their lower level of regulation, OTC devices have greater potential to be misused and damage brain function.[24] Critics also noted that in its current form, the Act omits support from licensed professionals, which has been found to improve patient satisfaction and product retention.[25] [26] Patient advocates noted that the Act does nothing for individuals with moderately-severe to profound hearing loss. Additionally, it was proposed that the creation of an OTC hearing device class may motivate insurance carriers to drop hearing aid coverage altogether.[27]

See also

External links

Notes and References

  1. Web site: H.R.2430 - 115th Congress (2017-2018): FDA Reauthorization Act of 2017. 2017-08-18. www.congress.gov. 2020-03-16.
  2. Web site: Deafness and hearing loss. www.who.int. en. 2020-03-16.
  3. Web site: Public Health and Scientific Information NCEH CDC. 2019-10-04. www.cdc.gov. en-us. 2020-03-16.
  4. Book: National Academies of Sciences, Engineering. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. 2016-06-02. National Academies Press . 978-0-309-43926-8. en.
  5. Book: Institute of Medicine and National Research Council. Hearing Loss and Healthy Aging: Workshop Summary. January 14, 2014. 10.17226/18735 . 24872992 . 978-0-309-30226-5 . March 16, 2019.
  6. Web site: Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. President's Council of Advisors on Science and Technology. October 26, 2015. March 16, 2019.
  7. Web site: Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care. Federal Trade Commission. 2017-01-03. en. 2020-03-16.
  8. Web site: Actions - H.R.1652 - 115th Congress (2017-2018): Over-the-Counter Hearing Aid Act of 2017. 2017-03-24. www.congress.gov. 2020-03-16.
  9. Web site: Actions - S.670 - 115th Congress (2017-2018): Over-the-Counter Hearing Aid Act of 2017. 2017-03-21. www.congress.gov. 2020-03-16.
  10. Web site: FDA allows marketing of first self-fitting hearing aid controlled by the user. U.S. Food and Drug Administration. 2018-10-05. FDA. en. 2020-03-16.
  11. Web site: De Novo Classification Request. U.S. Food and Drug Administration. November 20, 2019. Food and Drug Administration. March 16, 2020.
  12. Web site: Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices. 2019-12-30. Federal Register. 2020-03-16.
  13. Web site: Delayed Release of Proposed Over-the-Counter Hearing Aid Regulations . American Academy of Audiology . 2020-08-19 . 2020-10-05 . 2020-09-21 . https://web.archive.org/web/20200921122102/https://www.audiology.org/advocacy/delayed-release-proposed-over-counter-hearing-aid-regulations . dead .
  14. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00130. TWo Pi GmbH. 2017-05-22. Federal Trade Commission. en. dead. https://web.archive.org/web/20200919001641/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00130. 2020-09-19. 2020-03-16.
  15. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00134. Cellular Telecommunications Industry Association (CTIA). 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918093209/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00134. 2020-09-18. 2020-03-16.
  16. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00133. Consumer Technology Association. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918231656/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00133. 2020-09-18. 2020-03-16.
  17. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00136. Hearing Loss Association of America. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918114336/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00136. 2020-09-18. 2020-03-16.
  18. Web site: Hearing Health and Technology Workshop Project No. P171200. Bose Corporation. May 18, 2017. dead. https://web.archive.org/web/20210402121512/https://www.ftc.gov/system/files/documents/public_comments/2017/05/00140-140817.pdf. April 2, 2021. March 16, 2020.
  19. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00132. Lynn. Deborah. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200924212051/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00132. 2020-09-24. 2020-03-16.
  20. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00131. Stewart. Cynthia. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200919000403/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00131. 2020-09-19. 2020-03-16.
  21. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00142. Richard. Hammers. 2017-05-19. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918104429/https://www.ftc.gov/policy/public-comments/2017/05/19/comment-00142. 2020-09-18. 2020-03-16.
  22. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00137. Segev. Melissa. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918112650/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00137. 2020-09-18. 2020-03-16.
  23. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00139. Well. Barbara. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200924212148/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00139. 2020-09-24. 2020-03-16.
  24. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00128. Butterfield. Melissa. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918223703/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00128. 2020-09-18. 2020-03-16.
  25. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00141. Hammers. Chantal. 2017-05-22. Federal Trade Commission. en. dead. https://web.archive.org/web/20200924212727/https://www.ftc.gov/policy/public-comments/2017/05/19/comment-00141. 2020-09-24. 2020-03-16.
  26. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00135. Crosby. Noel. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200918115617/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00135. 2020-09-18. 2020-03-16.
  27. Web site: Hearing Health and Technology -- Workshop, Project No. P171200 #00138. Michaels. Michele. 2017-05-18. Federal Trade Commission. en. dead. https://web.archive.org/web/20200924213119/https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00138. 2020-09-24. 2020-03-16.