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

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.

Rachel-Ann Smith, Au.D., is a clinical associate professor in URI’s Department of Communicative Disorders and serves as director of the URI Speech and Hearing Center’s Audiology Clinic. (Courtesy R. Smith)

“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, audiology clinic director at the University of Rhode Island’s Speech and Hearing Centers.

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.”

URI’s Speech and Hearing Centers have locations in Kingston’s Independence Square at 25 West Independence Way, just off Kingstown Road, and in Pawtucket’s Independence Square Foundation at 500 Prospect Street. They offer speech and language services for adults and children. The Audiology Clinic offers the full range of adult and pediatric hearing exam services and testing and works with patients to teach communication strategies and tailor treatment, including offering device counseling as necessary, for adults. The Centers also offer special programs, ongoing support and therapy groups that are open to the community.

The Centers offer competitive pricing and accept all major insurance and Medicaid. They also work in partnership with the Ocean State Center for Independent Living to provide low cost hearing aids to those in need through the Gift of Hearing Program.

To learn more or to schedule an appointment visit: uri.edu/speech-hearing or call 401.874.5969.