Stay Informed

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

September 6, 2022
By Nicholas S. Reed and Frank R. Lin

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

We’ve each said this phrase countless times to patients with hearing loss and are prepared for the reaction that invariably follows: an expression of bewilderment about why a pair of hearing aids may have to be their third largest material purchase in life, after a house and car.

The release earlier this month of the Food and Drug Administration’s regulations for over-the-counter hearing aids will 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 win for Americans was mandated by the bipartisan Over-the-Counter Hearing Aid 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instead of having to go through clinicians, the new regulations disrupt the hearing aid oligarchy that benefited from outdated rules dating back to 1977.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 purchase these aids only through an audiologist or other licensed provider. As a result, five hearing aid manufacturers that meticulously cultivated relationships with hearing clinicians, or in some cases outright employed the hearing clinicians who sell their technologies, have historically controlled more than 90% of the world hearing aid market.

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

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

The smart use of regulatory reform to update outdated hearing aid regulations now amplifies another historical anachronism related to Medicare hearing policy.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 covering hearing aids and any related hearing rehabilitative services provided by audiologists. That poses a problem: While seniors may soon be able to purchase affordable OTC hearing aids, those who would benefit from seeing an audiologist for unconflicted professional guidance on how to manage their hearing loss with these devices cannot access such services under traditional Medicare.

There are several ways people can self-identify a hearing loss. Some will see an audiologist for testing. Some know 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 (F.R.L.) directs, has started an initiative called the Hearing 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, contained language that would have updated Medicare so audiological support services, as well as prescription hearing aids for those unable to benefit from OTC 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 2022, but similar language could be included in future bills that, at a minimum, should allow individuals covered by Medicare to receive hearing care support services from an audiologist.

In the end, the tally is clear. The winners include 40 million Americans with hearing loss, new companies that will finally be able to enter and compete in the hearing aid marketplace, and the public at large, which can have a renewed faith in the ability of government to implement smart policies for the greater good. Congress should repeat this impressive act with future legislation to address the historical anachronism in Medicare that prevents seniors from receiving hearing care support services.

Read more on STAT News