The Food and Drug Administration (FDA) is moving toward making hearing aids available without a prescription to those with mild or moderate hearing loss.

The goal is to boost accessibility and lower costs for the devices Hearing aids can cost thousands of dollars ($5,000 on average) and aren't usually covered by traditional Medicare or private insurance, and advocates argue that making them available over the counter can drastically lower the price.

The FDA’s proposed regulation implements the Over-the-Counter Hearing Aid Act, which was signed into law in 2017. The FDA is expecting opposition from hearing aid manufacturers and audiologist groups.

FDA statement announcing the rule

• Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing.

• Only about one-fifth of people who could benefit from a hearing aid use one.

• Hearing aids would be sold over the counter in more traditional brick-and-mortar retail stores or online (rather than doctors’ offices or specialty retail outlets).

• The new over-the-counter category would apply to certain air-conduction hearing aids intended for adults aged 18 and older who have perceived mild to moderate hearing loss.

• Hearing aids for severe hearing loss or for users younger than age 18 would be prescription devices.

• The FDA also issued an updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).

Interested parties can submit either electronic or written comments on the proposed rule by January 18, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021.