The FDA got it right with hearing aids. The Medicare update is the next step

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

We’ve all said this phrase countless times to hearing-impaired patients and braced ourselves for the reaction that invariably follows: an expression of bewilderment as to why a pair of hearing aids might be the third most expensive hardware purchase. most important thing in their lives, after a house and a car.

The release earlier this month of the Food and Drug Administration’s regulations on over-the-counter hearing aids will finally expand the options available to the 40 million hearing-impaired Americans, many of whom put off purchasing hearing aids knowing the exorbitant costs involved. This victory for Americans was mandated by the bipartisan Over-the-Counter Hearing Aids Act that was signed into law in 2017 and championed by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa).


By giving consumers direct access to hearing aids instead of having to go through clinicians, the new regulations disrupt the hearing aid oligarchy that benefited from outdated rules dating back to 1977. They allowed consumers to buy these aids only through the through an audiologist or other licensed provider. As a result, five hearing aid manufacturers who meticulously nurtured relationships with hearing care professionals, or in some cases outright employed the hearing care professionals who sell their technologies, have historically controlled over 90% of the global hearing aid market.

The release of the new regulations opens a clear path to market entry for consumer electronics companies that are already manufacturing innovative hearing technologies and new ones working in this area. Without the requirement of a hearing care professional as a mandated intermediary, more companies will be able to enter the hearing aid market, dramatically increasing competition and innovation in a stagnant hearing aid market and reducing costs.


Fortunately, the established hearing aid industry’s longstanding efforts to thwart, derail, and weaken new FDA 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The clever use of regulatory reform to update outdated hearing aid regulations now amplifies another historical anachronism related to Medicare hearing policy.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 enacted in 1965, Medicare was excluded from coverage of hearing aids and any related hearing rehabilitation services provided by audiologists. This poses a problem: while older people may soon be able to purchase affordable OTC hearing aids, those who would benefit from seeing an audiologist for conflict-free professional advice on how to manage their hearing loss with these devices cannot cannot access these services through traditional health insurance.

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

The Build Back Better Act of 2021, which Congress failed to pass, contained language that would have updated Medicare so that audiological support services, as well as prescription hearing aids for those who could not qualify for 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 Cut Inflation Act of 2022, but similar language could be included in future drafts. of law that, at a minimum, should allow people covered by Medicare to benefit from a hearing. audiologist care support services.

In the end, the count is clear. The winners include 40 million hearing-impaired Americans, new companies who can finally enter and compete in the hearing aid market, and the general public who can have renewed confidence in the government’s ability to implement smart policies to the greater good. Congress should repeat this impressive act with future legislation to address the historic Medicare anachronism that prevents older adults 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 was a Fellow of the National Academy of Medicine. consensus study on hearing care and testified before Congress on behalf of the OTC Hearing Aid Act in 2017.

About Bradley J. Bridges

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