FDA Hearing Aids Guidance: 2024 Compliance

Dec 22, 2023
Since April 14, 2023, manufacturers of OTC hearing aids must be in compliance with new FDA regulations. Learn about the regulations and how they can help you find quality OTC hearing aids.

By Cara Everett, MS, RDN
Medically Reviewed by Brian Murray, HIS
Reviewed by: Kathleen Cameron, BSPharm, MPH, Senior Director, NCOA Center for Healthy Aging
Fact Checked

Key Takeaways

Nearly 29 million adults in the United States need hearing aids, but the high price of prescription devices has traditionally put them out of reach for many people. [2]National Institute for Deafness and Other Communication Disorders. Quick Statistics About Hearing. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing It doesn’t help that Medicare and some private health insurers do not provide standard coverage for hearing aids.

To better serve hearing aid users, the FDA finalized OTC hearing aid regulations in August 2022, with the goal of lowering prices, increasing innovation and competition among hearing aid manufacturers, and making hearing aids more accessible to the millions of Americans who need them. [3]U.S. Food and Drug Administration. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. Aug. 16, 2022. Found on the internet at https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans

What rules do manufacturers need to follow to market their products as OTC hearing aids? Read on for more details.

What are the FDA regulations for OTC hearing aids?

The FDA’s final rule on OTC hearing aids outlines the following regulations for safety and efficacy: [4]Federal Register. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Aug. 17, 2022. Found on the internet at https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids

All OTC hearing aids must meet these guidelines for sale by April 14, 2023, which marks 180 days after the effective date of the FDA ruling. The FDA stated it would give manufacturers of hearing aids sold directly to consumers until the April 14 deadline to comply with the new regulations. Manufacturers that introduce new OTC hearing aids must also comply with these regulations before putting them on the market.

What do the FDA rules mean for you?

Knowing how the FDA defines OTC hearing aids allows you to make informed decisions when shopping for hearing aids. Look for the labeling details outlined above, and make sure any OTC devices you purchase are clearly labeled as OTC hearing aids rather than sound amplifiers, hearables, or personal sound amplification products (PSAPs).

While PSAPs and hearing aids both amplify sounds, they are different products intended for different uses. When the FDA issued its final rule on OTC hearing aids, the agency also released regulatory guidelines for hearing aids and PSAPs to clear up confusion among manufacturers and consumers about differences between the two types of products. [5]U.S. Food and Drug Administration. Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. Aug. 17, 2022. Found on the internet at https://www.fda.gov/media/87330/download

Hearing aids are classified as medical devices designed to treat hearing loss and are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act for safety and efficacy. [6]U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. March 29, 2018. Found on the internet at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act PSAPs are considered consumer electronics and are not meant to treat hearing loss. Rather, they are used by people with normal hearing to amplify all sounds in certain, often recreational, environments.

More changes ahead for hearing aid buyers

Our Reviews Team spoke with Frank Lin, MD, PhD, an epidemiologist with a research focus on hearing loss and aging at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. He predicted that in the coming months, we’ll see a lot of change within the hearing aids industry.

“[The OTC HA market] is very much evolving still, and that’s to be expected. This has never happened before. The U.S. is the first country in the entire world to regulate the market for OTC. So everyone is still figuring things out,” he said.

By defining OTC hearing aids within a distinct medical device category and ensuring they meet federal requirements, the FDA is opening the way for better access to hearing care while helping to protect consumers from false advertising and products that aren’t intended to treat hearing loss. Read our article on ways to avoid OTC hearing aid scams for more information.

Frequently Asked Questions

Yes, OTC hearing aids from manufacturers that comply with the FDA’s regulations are available for purchase now without a prescription.

OTC hearing aids can effectively amplify sounds for perceived mild to moderate hearing loss but may not provide enough amplification for more severe loss. Prescription devices offer more customization for the hearing aid user’s unique hearing loss profile.

OTC hearing aid costs range widely, with most models priced from $199–$999 per pair. More affordable options are now accessible thanks to increased competition and consumer avoidance of bundled professional fees.

Have questions about this review? Email us at reviewsteam@ncoa.org.

Sources

  1. Federal Register. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Aug. 17, 2022. Found on the internet at https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
  2. National Institute for Deafness and Other Communication Disorders. Quick Statistics About Hearing. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
  3. U.S. Food and Drug Administration. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. Aug. 16, 2022. Found on the internet at https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know
  4. Federal Register. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Aug. 17, 2022. Found on the internet at https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
  5. U.S. Food and Drug Administration. Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. Aug. 17, 2022. Found on the internet at https://www.fda.gov/media/87330/download
  6. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. March 29, 2018. Found on the internet at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
FDA OTC hearing aid regulations What the FDA rules mean for you More changes coming FAQ