FDA Approves Over-the-Counter Hearing Aids

In an effort to reduce the costs of hearing aids and make the devices more widely available, the Food and Drug Administration (FDA) finalized a ruling Tuesday that will allow adults with mild to moderate hearing problems to buy hearing aids over the counter and without a prescription.

Hearing aids can cost upwards of $5,000, according to Matthew Perrone of the Associated Press (AP), and Medicare doesn’t cover them, instead covering only diagnostic tests. Around 37.5 million American adults have some trouble hearing, according to the National Institutes of Health. But the FDA estimates that only one-fifth of people who could potentially benefit from a hearing aid use one, per the AP.

After the new rule takes effect in mid-October, the price of acquiring a hearing aid should eventually decline. About two-thirds of the cost of hearing aids comes from medical exams and fittings, Kate Carr, president of the Hearing Industries Association, which represents manufacturers, tells the AP. By eliminating the requirement for an examination and prescription, federal officials estimate the ruling could save people $2,800 on a pair of hearing aids, writes the New York Times’ Christina Jewett.

“The requirement to see a specialist was not only a burden and an annoyance for many consumers but it actually created a competitive barrier to entry,” Brian Deese, a White House economics adviser, tells the AP.

The new rule only applies to certain air-conduction hearing aids—hearing aids for children or severe hearing impairment will still require a prescription, according to NPR’s Rachel Treisman.

Researchers have tied hearing loss to walking problems, falls, dementia and depression, per NPR.

“[This] action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra said in a statement.

Congress first passed legislation to allow hearing aids to be sold over the counter in 2017, writes The Verge’s Nicole Wetsman. But implementing the rule moved slowly after that. In an executive order last year, President Biden urged the FDA to put the regulations in place, per The Verge. Then, after the FDA proposed the rule last fall, a period of public comment followed, according to the Times.

During the public comment period, various industry groups pushed back against the rule, citing a concern that it would allow low-quality or dangerous hearing aids to be sold to consumers, writes the Times. But in a June investigative report from Senators Chuck Grassley, a Republican from Iowa, and Elizabeth Warren, a Democrat from Massachusetts, who together introduced the 2017 bill, the lawmakers countered this idea. The rule, they say, includes safety provisions, such as a limit on sound output, and will increase competition in the hearing aid market.

Currently, the top five hearing aid manufacturers control more than 90 percent of the market.

A more competitive landscape could lead to more innovative hearing aid designs, per the Times. “This could fundamentally change technology,” Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, tells the Times. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work.”

Will Sullivan | | READ MORE

Will Sullivan is a science writer based in Washington, D.C. His work has appeared in Inside Science and NOVA Next.