FDA’s new rule on over-the-counter hearing aids and what consumers should keep in mind

Newswise — KINGSTON, R.I. – September 15, 2022 – A recent decision by the U.S. Food and Drug Administration to make hearing aids available over-the-counter is expanding access to assistance for millions of adults across the country who may have trouble hearing. The new rule was issued by the FDA in mid-August and will take effect mid-October. It essentially establishes a new category of hearing aids for consumers with perceived mild to moderate hearing impairment, enabling them to purchase hearing aids directly from stores or online retailers without the need for a medical exam or prescription. 

According to the National Institutes of Health, close to 30 million adults in the United States suffer from some degree of hearing loss and could benefit from hearing aids. Yet, the average cost of one adult hearing aid averages about $2,000, and hearing aids are not covered by Medicare, putting them out of reach of many Americans. The rule is expected to help lower the cost of the devices but before you run out and purchase one on your own, there are some important considerations to keep in mind.

“The big concern is whether consumers will be able to receive the level of assistance necessary to meet their needs depending on their degree of hearing loss,” says Rachel-Ann Smith, a clinical associate professor in University of Rhode Island's Department of Communicative Disorders. She also serves as director of the URI Speech and Hearing Centers' Audiology Clinic. 

Smith welcomed the new rule and the access it will provide for those people who otherwise may go without, but cautioned consumers against going it alone without first having a good assessment of what their needs might be.

“When we talk about ‘perceived’ mild to moderate hearing loss, we are talking about an individual’s own perception of their ability to hear. Hearing loss most often occurs gradually so people acclimate – but it may be that what someone perceives as a mild to moderate hearing loss is actually quite a severe hearing loss.”

Smith recommends getting your hearing tested with an audiologist to determine whether a hearing device is right for you. Most health insurance plans cover an annual hearing test and diagnostic evaluation – though some may require a referral.

She noted that certain devices coming on the market may remain somewhat costly while those on the lower end of the cost spectrum may function primarily as amplifiers.

“Most of these products are likely to provide some level of relief – but it’s also possible to have an untreated medical problem that if treated may clear up your issue. Bottom line – to be better informed, it’s smart to visit a professional,” said Smith. “Part of our job as audiologists is not only to test your hearing but also to provide counseling as to how to manage a hearing loss and what products can help – so we can help point out what will work best for you, what might be a waste of money and how to make an educated purchase.”

The new rule becomes effective October 17. To learn more about different types of hearing aids and sound amplification devices and how they work, visit FDA Consumer Updates.