Skip to main content
Tags: over the counter hearing aids | fda

Over-the-Counter Hearing Aids Expected This Fall in US

Over-the-Counter Hearing Aids Expected This Fall in US
(Dreamstime)

Tuesday, 16 August 2022 09:54 AM EDT

Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday.

The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don't require a medical exam, a prescription and other specialty evaluations. Instead the devices will be sold online or over-the-counter at pharmacies and other retail stores.

The devices are intended for people mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. The FDA first proposed the rule last October. The new rule will take effect in mid-October.

Biden administration officials highlighted the potential cost savings.

“Today’s 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.

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

Cost is a big obstacle now. Between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests.

The new over-the-counter status won't apply to devices for more severe hearing loss, which will remain prescription only.

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. The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face penalties, such as fines or product seizures.

The FDA said it changed several parts of its initial proposal in response to public comments, including clarifying how the federal rule will impact state regulations on hearing aids.

Once the federal rule takes 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.

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.

© Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.

StreetTalk
The U.S. Food and Drug Administration on Tuesday passed a rule that creates a new category of over-the-counter (OTC) hearing aids to be sold directly to the millions of Americans in need of the devices.
over the counter hearing aids, fda
388
2022-54-16
Tuesday, 16 August 2022 09:54 AM
Newsmax Media, Inc.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 

Interest-Based Advertising | Do not sell or share my personal information

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
America's News Page
© 2025 Newsmax Media, Inc.
All Rights Reserved
Download the Newsmax App
NEWSMAX.COM
America's News Page
© 2025 Newsmax Media, Inc.
All Rights Reserved