By Cara Everett, MS, RDN
Medically Reviewed by Brian Murray, HIS
Reviewed by: Kathleen Cameron, BSPharm, MPH, Senior Director, NCOA Center for Healthy Aging
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 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
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
- 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
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 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.
Read our hearing aids buyer’s guide to learn more about the distinction between hearing aids and PSAPs.
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.
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