FDA Hearing Aids Guidance: 2024 Compliance

Key Takeaways

• Designed for adults with perceived mild to moderate hearing loss, over-the-counter (OTC) hearing aids can be purchased online and in stores without a hearing exam or prescription.
• The FDA’s final rule on OTC hearing aids went into effect on Oct. 17, 2022, establishing OTC devices in a category separate from prescription hearing aids.
• Manufacturers that were selling hearing aids directly to consumers prior to Oct. 17, 2022, had until April 14, 2023, to comply with FDA regulations for OTC hearing aids, and new OTC hearing aids must conform to the regulations before going on the market. ^[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

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.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids

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

• Scope: OTC hearing aids are air-conduction hearing aids ⓘAir-conduction hearing aids use wireless technology to amplify sound frequencies for people with hearing loss. intended for adults age 18 and older with perceived mild to moderate hearing loss.
• Labeling: Manufacturers must use clear, easy-to-read language that states “OTC hearing aid” on the website and/or package. Packaging must also include language that explains who the device is appropriate for and outlines parameters for when someone may need to see a hearing care professional.
• Performance: OTC hearing aids cannot amplify sounds more than 111 decibels of sound pressure level, or 117 decibels of sound pressure level for certain devices.
• Design: When fully inserted into the ear canal, the deepest part of an OTC hearing aid must remain at least 10 millimeters from the eardrum. Users must also be able to change the volume.

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.

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