Lower Cost, Over-the-Counter Hearing Aids Approved by FDA

By Yehudit Garmaise

The US Food and Drug Administration (FDA) has allowed hearing aid manufacturers to sell their devices over-the-counter (OTC) and at much lower prices, enabling many more Americans to get the help they need.

Only approximately 20% of the 30 million Americans who have hearing loss have previously sought help. According to the Associated Press, this low number is likely because hearing aids cost up to $5,000 and require medical exams from specialists, hearing tests, professional fittings, and prescriptions.

Fortunately, the FDA approved OTC hearing aids on Oct. 17, 2022. At that point, more than 12 manufacturers released different models of these life-changing devices at drastically decreased prices. 

Walmart, for instance, not only offers OTC hearing aids that range from approximately $200 to $1,000 per pair, but its health centers provide hearing tests that were previously only offered at doctors' offices.

In addition, Walgreens drugstores now sell Lexie Lumen hearing aids for $799.

Best Buy sells OTC hearing aids in nearly 300 stores and online, where the company also provides online hearing assessments. In Best Buy stores, trained employees can help customers determine the severity of their hearing loss and how to fit the devices.

Only adults with mild-to-moderate hearing loss can now buy hearing aids without doctors' visits and prescriptions. Examples of mild-to-moderate hearing loss include those who have trouble following group conversations in noisy places or hearing voices over the phone.

People who suffer from more profound hearing loss are not eligible for OTC hearing aids, said Sterling Sheffield, an audiologist who teaches at the University of Florida. An example of profound hearing loss includes those who have trouble hearing louder noises, like power tools and cars.

Additionally, OTC hearing aids are not yet available for people who have lost their hearing suddenly or in just one ear.

Patients who are unsure how to describe their hearing loss levels can still get specialists' input, which is often covered by insurance, before heading to nearby stores to buy OTC hearing aids.

Alternatively, several apps and online questionnaires can help patients determine the extent of their hearing loss.

People shopping for FDA-approved hearing aids sold without prescriptions should look for labels that say the devices are OTC.

The OTC labels, which the FDA requires, help customers distinguish between quality OTC hearing aids and cheaper devices. These cheaper options are sometimes called "sound amplifiers" or "hearing amplifiers," which are not subject to FDA review.

People need to read the hearing aids' descriptions and the research stores' return policies, said Barbara Kelley, executive director of the Hearing Loss Association of America.

Photo credit: Flickr