FDA Rule Will Allow Over-the-Counter Hearing Aids and Cut the Cost for Buyers

The Food and Drug Administration (FDA) on Tuesday announced a proposal that would permit people to buy hearing aids without a prescription and lower costs for the usually pricey devices, the Associated Press reported.

If approved, the proposed rule would remove several barriers to millions of Americans who need to access the devices. It would allow patients with mild to moderate hearing problems to bypass the hearing exams and prescriptions now required to get hearing aids, the FDA said. The proposal would also allow people to buy hearing aids either online or over the counter at pharmacies and other stores, the AP said.

The cost of getting a hearing aid is a big deterrent to would-be users. Americans can pay up to $5,000 to get fitted for and purchase the device, while insurance coverage and Medicare aid are limited to nonexistent. Medicare pays only for diagnostic tests and not the devices themselves.

The FDA proposal, if approved, would allow greater competition and lower prices as a result, U.S. officials said Tuesday.

For more reporting from the Associated Press, see below.

FDA Proposes Hearing Aid Access Changes
Federal health regulators have unveiled a proposal to allow Americans to buy hearing aids without a prescription. Above, Kim M. Smith, leader of the Utah Deaf Hospital Rights movement and president of the Utah Association of the Deaf, brushes her hair away from her hearing aid at Alta View Hospital in Sandy, Utah, on January 20, 2020. Isaac Hale/The Daily Herald via AP

The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.

More than 37 million Americans, or 15 percent of adults, have trouble hearing, according to the FDA, but only about one-fifth of people who can benefit from a hearing aid use one.

"Today we open the door to an easier process and a more affordable process," Health and Human Services Secretary Xavier Becerra told reporters.

The agency will take public comments on its proposal for 90 days before finalizing the new rules. FDA officials wouldn't speculate on when new devices would actually hit store shelves.

Consumer electronic companies for years have produced lower-cost "personal sound amplification" devices, but U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. Regulators said Tuesday that the new rules will make explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face federal penalties, such as fines or product seizures.

For their part, makers of hearing aids have long argued that professional expertise is required to pick the right device and adjust its settings to work properly.

Once the FDA rules take effect, traditional manufacturers are expected to begin selling cheaper, direct-to-consumer models. Eventually, advocates predict the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.

The looser regulations would not apply to devices for people with severe hearing loss or for children. Also, the agency said over-the-counter devices would be required to have volume limits and other measures to help prevent injuries.

Companies making over-the-counter hearing aids generally wouldn't be required to conduct studies in people. Instead, they would submit applications to the FDA showing they met its standards for the devices.

Tuesday's announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices by August 2020. The agency missed that deadline, in part due to the workload of the COVID-19 pandemic.

Additionally, an executive order by President Joe Biden earlier this year set a timetable for the agency to take action no later than mid-November.

FDA Campus
The new proposal from the Food and Drug Administration would allow patients with mild to moderate hearing problems to bypass the hearing exams and prescriptions now required to get hearing aids. Above, the FDA's campus in Silver Spring, Maryland. Andrew Harnik/AP Photo