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November 5, 2021

Changes to Medicare Policy Needed to Address Hearing Loss

Author Affiliations
  • 1Department of Epidemiology, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 3Menzies Centre for Health Policy, University of Sydney, Sydney, New South Wales, Australia
JAMA Health Forum. 2021;2(11):e213582. doi:10.1001/jamahealthforum.2021.3582

The expansion of Medicare to include hearing care coverage is squarely on the federal legislative agenda following the recent endorsements of President Biden and Congressional leaders. Such action would be synergistic with a recent White House executive order aimed at improving the affordability of hearing aids that instructs the US Food and Drug Administration (FDA) to release long-delayed regulations for over-the-counter (OTC) hearing aids that would be directly available to consumers. To meet the needs of Medicare beneficiaries with hearing loss, changes to Medicare proposed as part of the fiscal year 2022 budget reconciliation bill must account for the imminent availability of OTC hearing aids as well as differing levels of hearing loss severity.

Over-the-Counter Hearing Aids

Hearing loss among older adults has received increasing recognition as a public health priority.1 Recent epidemiologic research1 has revealed an independent association of hearing loss with important aging outcomes, including dementia, falls, and health care use. However, less than 20% of persons with hearing loss use hearing aids, partly because of high device costs and lack of coverage in the Medicare program. Recent trends suggest an increased disparity in hearing aid use between high-income and lower-income Medicare beneficiaries.1,2

Spurred by calls from the National Academy of Medicine1 and the President’s Council of Advisors on Science and Technology3 to increase the affordability and accessibility of hearing aids, Congress passed the Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization Act (HR 2430, §934) of 2017.4 This law instructed the FDA to create regulations for a class of OTC hearing aids intended for individuals with mild to moderate hearing loss. Although release of these regulations has been delayed,5 recent White House executive action6 has called for release of regulations by the end of 2021. Once finalized, this new regulatory class of OTC hearing aids will allow for consumer technology manufacturers to enter the hearing aid market, thereby facilitating increased competition and innovation in a market that is presently so concentrated that just 5 companies comprise more than 95% of the global hearing aid market.1 The sale of regulated OTC hearing aids lays the groundwork for a more robust hearing care marketplace with improved accessibility. However, complementary Congressional legislation to change Medicare is needed to ensure that beneficiaries experience the fullest potential gains from these OTC hearing aids and to meet the needs of all individuals with hearing loss.

First, OTC hearing aids will only benefit individuals with mild to moderate hearing loss4,5 and will not address the needs of those with more substantial hearing loss who need greater levels of amplification. These individuals will therefore need to continue purchasing conventional hearing aids through an audiologist or hearing aid dispenser, where the average cost of a pair of hearing aids is $4700.1

Second, access to hearing care services that support individuals in learning how to use hearing aids is limited and requires out-of-pocket payment. These services provide a critical component of hearing care and are underused by older adults.7 In the US, the costs of hearing care services that support device fitting and customization are commonly bundled in the price of hearing aids. While the pending OTC hearing aid regulations will expand accessibility to devices, they also serve to decouple the device purchase from hearing care services, which remain uncovered by Medicare.

Policy Based on Degree of Hearing Loss

A potential solution for hearing care coverage to complement the OTC hearing aid market is for Medicare to cover conventional hearing aids only for individuals with greater hearing loss or others who cannot derive benefit from OTC hearing aids (eg, those with a complex conductive pattern of hearing loss). In addition, Medicare could cover a certain number of annual hearing care service visits for all individuals, regardless of degree of hearing loss. These visits would provide the necessary audiologic support services for those with severe hearing loss using conventional hearing aids as well as supporting beneficiaries with mild to moderate levels of hearing loss who purchase OTC hearing aids. This approach previously served as the framework of the Medicare Hearing Act of 2019 (H.R. 4618) and subsequently the Elijah C. Cummings Lower Drug Costs Now Act (H.R.3) that passed the House in December 2019. Under this approach, all beneficiaries could receive hearing care services, but fewer older adults would be eligible for coverage of conventional hearing aids, resulting in lower total costs to Medicare compared with covering conventional hearing aids for all adults with hearing loss.

However, a policy based on degree of hearing loss would prompt other important considerations. First, how is the degree of hearing loss severity defined? This issue has been recently complicated by changes to the World Health Organization (WHO) categories of hearing loss. Former WHO categories of hearing loss present at the time the Medicare Hearing Act was incorporated into HR 3 in 2019 differentiated hearing loss severity into 5 categories: normal (≤25 dB), mild (26-40 dB), moderate (41-60 dB), severe (61-80 dB), and profound (≥81 dB). In contrast, the updated WHO categories adopted in 2020 create 7 different groups: normal (≤19 dB), mild (20-34 dB), moderate (35-49 dB), moderately severe (50-64 dB), severe (65-79 dB), profound (80-94 dB), and complete (≥95 dB). The expanded WHO definition of mild to moderate hearing loss (from 26-60 dB to 20-64 dB) will substantially increase the number of Medicare beneficiaries in this category.

Second, how will exceptions to the proposed policy be addressed? The categorizations of hearing loss rely on definitions based on an average of hearing sensitivity at specific frequencies of sound and do not account for the full spectrum of common auditory frequencies (125-8000 Hz) important for speech. Individuals with complex needs (eg, concurrent physical or mental impairments, abnormal ear anatomy) also may not benefit from OTC hearing aids. Given this reality, individuals with the hearing level that may be categorized as mild to moderate loss may benefit from conventional hearing aids. One potential solution is a waiver system under Medicare whereby either qualified audiologists or physicians approve Medicare beneficiaries who do not meet the threshold for conventional hearing aid coverage but have not achieved benefit from using OTC hearing aids. Such a waiver system could balance cost and quality of care by requiring beneficiaries to attempt to use the current OTC hearing aid marketplace before receiving a waiver.

Third, the Centers for Medicare & Medicaid Services must revisit the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes for hearing loss to create a feasible system to monitor eligibility and audit fraud cases under such a system. The current ICD-10 codes for hearing loss are limited to type (eg, sensorineural, conductive, mixed), symmetry (eg, bilateral, unilateral, asymmetric), and origin (eg, ototoxic) of hearing loss but do not address the degree of hearing loss.

Conclusions

Hearing aids in the US are poised to become substantially more accessible and affordable pending implementation of the OTC Hearing Aid Act in the next year. However, complementary Medicare coverage of hearing care services and conventional hearing aids (for those who cannot benefit from OTC hearing aids) is also warranted to ensure that the hearing and communication needs of all Medicare beneficiaries are fully realized and met.

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Article Information

Published: November 5, 2021. doi:10.1001/jamahealthforum.2021.3582

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Reed NS et al. JAMA Health Forum.

Corresponding Author: Nicholas S. Reed, AuD, Department of Epidemiology, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, 2024 E Monument St, Ste 2-700, Baltimore, MD 21205 (nreed9@jhmi.edu).

Conflict of Interest Disclosures: Dr Reed reported receiving a grant from National Institute on Aging (K23AG065443) during the conduct of the study; and being a member of an advisory board for Neosensory and Shoebox Inc. Dr Lin reported receiving personal fees from Frequency Therapeutics and personal fees from Caption Call outside the submitted work; and being the director of a public health research center funded in part by a philanthropic gift from Cochlear Ltd to the Johns Hopkins Bloomberg School of Public Health. Dr Willink reported receiving grants from The Commonwealth Fund 20192345 during the conduct of the study.

Funding/Support: This work was funded in part by the Eleanor Schwartz Charitable Foundation and the Cochlear Center for Hearing and Public Health at Johns Hopkins University Bloomberg School of Public Health and supported by grants NIH/NIA K23AG065443 (Dr Reed) from the National Institutes of Health.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

References
1.
National Academies of Sciences, Engineering, and Medicine. Hearing health care for adults: priorities for improving access and affordability. Accessed June 1, 2021. http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx
2.
Reed  NS, Garcia-Morales  E, Willink  A.  Trends in hearing aid ownership among older adults in the United States from 2011 to 2018.   JAMA Intern Med. 2021;181(3):383-385. doi:10.1001/jamainternmed.2020.5682PubMedGoogle ScholarCrossref
3.
President’s Council of Advisors on Science and Technology. Letter to the president, October 2015. Accessed March 1, 2017. https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf
4.
Reed  NS, Lin  FR, Willink  A.  Hearing care access? focus on clinical services, not devices.   JAMA. 2018;320(16):1641-1642. doi:10.1001/jama.2018.11649PubMedGoogle ScholarCrossref
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Franck  KH, Rathi  VK.  Regulation of over-the-counter hearing aids: deafening silence from the FDA.   N Engl J Med. 2020;383(21):1997-2000. doi:10.1056/NEJMp2027050PubMedGoogle ScholarCrossref
6.
White House Briefing Room. FACT SHEET: Executive Order on Promoting Competition in the American Economy, July 2021. Accessed July 9, 2021. https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/09/fact-sheet-executive-order-on-promoting-competition-in-the-american-economy/
7.
Willink  A, Reed  NS, Lin  FR.  Access to hearing care services among older Medicare beneficiaries using hearing aids.   Health Aff (Millwood). 2019;38(1):124-131. doi:10.1377/hlthaff.2018.05217PubMedGoogle ScholarCrossref
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