Adults in the U.S. with mild to moderate hearing loss will no longer be required to have a hearing-aid prescription or a fitting by an audiologist following a final rule by the Food and Drug Administration aimed lowering the cost of the devices.
Hearing aids for over-the-counter sales could be available in stores as soon as mid-October, the FDA said in a statement on Tuesday. For adults with severe hearing impairment, or children, hearing aids will still be prescription devices.
The final rule is based on bipartisan legislation signed into law in 2017, with the intention of lowering the cost of hearing aids. According to a survey by Consumer Reports, people typically spend about $2,680 out of pocket for the devices.
The FDA in October 2021 created a draft guidance in response to the legislation and an executive order from President Joe Biden. The agency fielded several comments from hearing-aid manufacturers who had concerns about the specifications for over-the-counter devices.
Senators Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa, who sponsored the original bill, accused hearing-aid manufacturers of launching “astroturf campaigns,” citing from letters found in submitted comments, as they urged the FDA last month to finalize the policy.
The FDA ultimately took some of the industry's suggestions into account in the final rule. The agency lowered the general maximum sound output for over-the-counter hearing aids from 115 decibels to 111 decibels. With input-controlled compression, the maximum is now 117 decibels.
The agency also set limits on insertion depth in the ear canal and added a requirement that all over-the-counter hearing aids have user-adjustable volume control. The devices also must meet certain performance specifications and design requirements.