What it means for you
Since Oct. 17, 2022, adults with perceived mild to moderate hearing loss can buy FDA-regulated hearing aids in stores and online without a medical exam or fitting. The change came from a 2017 bipartisan law and a 2022 FDA rule.
Who benefits: Adults 18 and older with perceived mild to moderate hearing loss. About 28.8 million U.S. adults could benefit from hearing aids, according to the National Institutes of Health.
Before 2022, federal rules generally called for a medical evaluation before a hearing-aid sale, although adults could sign a waiver. Most hearing aids were sold through specialty outlets with professional services bundled into the price, and a pair often cost thousands of dollars. Now adults with perceived mild to moderate hearing loss can buy certain FDA-regulated air-conduction hearing aids in a store or online without an exam, prescription, or fitting. People with severe or profound hearing loss, and anyone younger than 18, still need prescription hearing aids.
Sens. Elizabeth Warren, a Democrat, and Chuck Grassley, a Republican, first introduced the proposal in 2016. They reintroduced it in 2017 with Sens. Maggie Hassan, a Democrat, and Johnny Isakson, a Republican. Reps. Joe Kennedy III, a Democrat, and Marsha Blackburn, a Republican, led the House version. House committee leaders Greg Walden, a Republican, and Frank Pallone, a Democrat, helped advance the provision in the larger FDA bill. That bill passed 94–1 in the Senate and by voice vote in the House, and President Donald Trump signed it in August 2017.
The FDA missed the law’s August 2020 deadline. In July 2021, President Joe Biden issued an executive order requiring HHS to publish a proposed rule within 120 days. FDA Commissioner Robert Califf signed the final rule in August 2022, and it took effect on October 17, 2022.
When stores began selling them, the White House said Walmart priced its OTC models at $199 to $999, compared with $4,400 to $5,500 for its prescription models.
Health careLower costsSeniors
Sources
- OTC Hearing Aids: What You Should KnowU.S. Food and Drug Administration
- Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (final rule)Federal Register, August 17, 2022
- Quick Statistics About HearingNational Institute on Deafness and Other Communication Disorders
- Fact sheet: Cheaper hearing aids now in storesThe White House (Biden administration archive), October 17, 2022
- Members of Congress Introduce Bipartisan Legislation to Make Hearing Aids Available Over the CounterOffice of U.S. Senator Elizabeth Warren, March 21, 2017
- OTC Hearing Aid Act passed by US HouseThe Hearing Review, July 13, 2017
- FDA Reauthorization Act of 2017GovInfo, August 18, 2017
- Statutory deadline for OTC hearing aid rule missedRegulatory Affairs Professionals Society, November 17, 2020
- Executive Order 14036: Promoting Competition in the American EconomyFederal Register, July 14, 2021
How we checked this
Drafted by Claude Opus 5.5 (Anthropic) on November 11, 2026. Checked against its sources by GPT-5.6-sol (OpenAI) on November 11, 2026, which corrected it. Confirmed the current FDA rule, impact figures, enactment dates, and exact 94–1 Senate roll call. Corrected the pre-2022 requirements, completed the legislative and implementation credits, and refreshed the status date.
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