Over-the-counter hearing aids can be sold following FDA ruling

The hearing aids could be available as soon as October, the FDA said.

August 16, 2022, 6:46 PM

Hearing aids can be sold over the counter in an effort to increase access and lower costs, the U.S. Food and Drug Administration announced on Tuesday. The move will allow those with mild to moderate hearing loss to directly purchase hearing aids from retailers.

Previously, those with mild to moderate hearing loss needed a prescription to receive a hearing aid, which required a medical exam, possibly by a specialist such as an audiologist.

Not only can this process be costly, but it can also take time, depending on provider availability, experts said.

The news was celebrated by the Hearing Industries Association, a group representing hearing aid manufacturers and other industry stakeholders, which said in a statement the "change will expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss.”

“In the United States, we see wealthier individuals being able to access hearing aids and individuals who are living at or below federal poverty level struggling to access hearing aids,” Dr. Nicholas Reed, assistant professor at Johns Hopkins University Bloomberg School of Public Health, told ABC News.

This ruling came just prior to President Joe Biden signing the Inflation Reduction Act on Tuesday, which proponents claim will further reduce drug prices and keep health insurance affordable for millions of Americans.

Jennifer Nealon, Marketing Director at Hear Again America, holds a hearing aid that they sell, Oct. 19, 2021, in Boca Raton, Fla.
Joe Raedle/Getty Images

When will they be available?

"Americans could see over-the-counter hearing aids available as early as mid-October," FDA Commissioner Robert Califf said at an FDA briefing Tuesday.

Califf said the ruling will clarify the regulatory requirements for hearing aids and personal sound devices, also referred to as PSAPs. He said it will take time for manufacturers to ensure that they are meeting these new requirements.

“These actions reflect the FDA's commitment to safely lowering barriers to access, providing consumers with greater choices to lower prices, and helping to facilitate innovation in hearing aid technology,” Califf said.

Who can use them?

“The new over-the-counter category applies to certain air conduction hearing aids, intended for adults aged 18 and older who have perceived mild to moderate hearing loss,” Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, said at an FDA briefing Tuesday.

Air conduction hearing aids are worn inside the ear or on the ear, with an inside the ear component and amplified sound into the ear canal. In an effort to prevent further hearing loss, these devices will have sound limits.

“Hearing aids for severe hearing loss or for users younger than age 18 will be prescription devices, to assure patient safety as well as effectiveness,” Shuren said.

What are the implications?

“The FDA estimates this rule will save consumers on the order of about $1,400 per individual hearing aid, or almost, or over $2,800 per pair. And that's the direct savings,” Brian Deese, White House Director of National Economic Council, said at the FDA briefing Tuesday.

While these are just estimates in savings, Deese also believes this ruling will increase innovation and competition in the market.

“The requirement to see a doctor or a hearing specialist was an example of what economists call a barrier to entry. It was a regulation that kept more companies or more innovators from entering the market to compete,” Deese said.

Emma Egan is an MPH candidate at Brown University and a contributor to the ABC Medical Unit.