Science and Persistence — The Right Mix for Improving Access to Hearing Aids

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By Executive Director and CEO James Appleby, BSPharm, MPH

June 19, 2017

When Medicare was introduced more than 50 years ago, several major aspects of older adult health care were not included in the coverage provided — including vision health, oral health and hearing health.  In the case of eye health, the marketplace has provided older adults with access to widely available and affordable options. With oral health and hearing health, much remains to be done.

It’s exciting to see movement here in Washington to address the latter issue, with an important bill regarding the regulation of over-the-counter (OTC) hearing aids making its way through the legislative process in a bipartisan manner.

Two-thirds of adults 70 and over have a hearing loss that affects their daily conversation. And hearing loss has serious health consequences that are often overlooked, with research showing it is associated with isolation, depression, and the risk of developing dementia. Because only one in five people with hearing loss has a hearing aid, steps to make hearing aids more widely available would be enormously valuable.

This proposed legislation would enable hearing aids to be sold over the counter, which would expand consumer choice, open the market to innovative hearing technologies, and drive down prices so that millions more Americans could access affordable hearing aids. Further, it would require the FDA to write regulations ensuring that this new category of OTC hearing aids meets the same high standards for safety, consumer labeling, and manufacturing protections as all medical devices, providing consumers with the option of an FDA-regulated device at lower cost.

These proposed changes are supported by science, with recent reports from two national blue-ribbon panels, the President’s Council of Advisors on Science and Technology and the National Academies of Science, Engineering, and Medicine. Both recommend that the FDA create a new regulatory classification for OTC hearing aids, and performance standards for those new devices.

And a longtime GSA member, Frank Lin, MD, PhD, is providing the persistence. Working with other committed colleagues, Frank has been championing action to address hearing loss for some time. He has been active with this specific legislation, providing testimony to Congressional Committees considering the bill. For a primer on the issue, Frank and his colleague Jan Blustein, MD, PhD, authored a recent op-ed in The Hill, a newspaper covering events on Capitol Hill. I also contributed a piece on GSA’s behalf.

While there are several steps ahead, the prognosis for this legislation is good. This new law is part of an FDA bill (H.R. 2430) that was passed out of the full Energy and Commerce Committee recently with a 54-0 vote!

This case is a good example of how good science and persistence can be paired up to establish policies that improve the lives of older adults.