The FDA got it right with hearing aids. Updating Medicare is next

“He would really benefit from hearing aids, but they’re not covered by Medicare and cost about $4,000.”

Each of us has said this phrase countless times to patients with hearing loss and is primed for the reaction that invariably follows: an expression of bewilderment as to why a pair of hearing aids can be the third largest material purchase in life, after of a house. and car

The release earlier this month of the Food and Drug Administration’s regulations for over-the-counter hearing aids finally expand the options available to the 40 million Americans with hearing loss, many of whom put off buying hearing aids knowing the outrageous costs involved. This victory for the Americans was ordered by the bipartisan Over-the-Counter Hearing Aid Law which was signed into law in 2017 and sponsored by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa).


By giving consumers direct access to hearing aids instead of going to doctors, the new regulations disrupt the hearing aid oligarchy that profited from obsolete rules dating back to 1977. They allowed consumers to purchase these hearing aids only through an audiologist or other licensed provider. As a result, five hearing aid manufacturers that have meticulously cultivated relationships with audiologists or, in some cases, directly employed the audiologists who sell their technologies, have historically controlled more than 90% of the global hearing aid market.

The launch of the new regulations provides a clear path for market entry for consumer electronics companies already making innovative hearing technologies and new ones working in this area. Without the requirement of a hearing care provider as a mandatory middleman, more companies will be able to enter the hearing aid market, dramatically increasing competition and innovation in a stagnant hearing aid market and driving down costs.


Fortunately, the longstanding efforts of the established hearing aid industry to stymie, derail, and weaken the FDA’s new hearing aid regulations, documented in a recent report by Warren and Grassley, ultimately failed.

The clever use of regulatory reform to update outdated hearing aid regulations now amplifies another historical anachronism related to Medicare hearing policy. When it was enacted in 1965, Medicare was excluded from coverage for hearing aids and any related hearing rehabilitation services provided by audiologists. That poses a problem: While older people may soon be able to purchase affordable over-the-counter hearing aids, those who would benefit from seeing an audiologist for professional, conflict-free guidance on how to manage their hearing loss with these devices are unable to access such services under traditional Medicare.

There are several ways that people can self-identify a hearing loss. Some will see an audiologist for testing. Some know this based on their experiences and comments from others. And some will use one of the various screening tests that are available online. The Johns Hopkins Cochlear Center for Hearing and Public Health, which one of us (FRL) directs, has started an initiative called audience number to help people better understand their hearing and how it changes over time.

The Build Back Better Act of 2021, which Congress did not pass, content language that would have updated Medicare so that audiological support services, as well as prescription hearing aids for those who can’t benefit from over-the-counter devices, would have been covered. This benefit was not included in the passage of a more limited version of this budget reconciliation bill, the Inflation Reduction Act of 2022but similar language could be included in future bills that, at a minimum, should allow people covered by Medicare to receive hearing care support services from an audiologist.

In the end, the account is clear. The winners include the 40 million Americans with hearing loss, startups that will finally be able to enter and compete in the hearing aid market, and the general public, who may have renewed faith in the government’s ability to implement smart policies for the Greater Good. Congress should repeat this impressive act with future legislation to address the historic anachronism in Medicare that prevents seniors from receiving hearing support services.

Nicholas S. Reed is an audiologist and assistant professor in the department of epidemiology at the Johns Hopkins Bloomberg School of Public Health. Frank R. Lin is an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health, and a former member of the National Academy of Medicine. consensus study about hearing care and testified before Congress on behalf of the OTC Hearing Aid Act in 2017.

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