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


KINGSTON, RI – September 15, 2022 – A recent decision by the United States Food and Drug Administration to make hearing aids available over-the-counter expands access to assistance for millions of adults across the country who may have difficulty hearing. The new rule was published by the FDA in mid-August and will go into effect in mid-October. It essentially establishes a new category of hearing aids for consumers with mild to moderate perceived hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical exam or medical examination. ‘a prescription.

According to the National Institutes of Health, nearly 30 million adults in the United States have some degree of hearing loss and could benefit from hearing aids. Still, the average cost of an adult hearing aid averages around $2,000, and hearing aids aren’t covered by Medicare, putting them out of reach for many Americans. The rule should help reduce the cost of devices, but before you run out and buy one on your own, there are a few important considerations to keep in mind.

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

“The big concern is whether consumers will be able to receive the level of support necessary to meet their needs based on their degree of hearing loss,” says Rachel-Ann Smith, director of the audiology clinic at University of Rhode Island Speech and Hearing Centers.

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

“When we talk about mild to moderate ‘perceived’ hearing loss, we are talking about an individual’s perception of their ability to hear. Hearing loss most often happens gradually so people get used to it – but what someone may perceive as mild to moderate hearing loss is actually quite severe hearing loss.

Smith recommends having your hearing tested by an audiologist to determine if a hearing aid is right for you. Most health insurance plans cover an annual hearing test and diagnostic evaluation – although some may require a referral.

She noted that some devices coming to market may remain somewhat expensive, while those on the lower end of the cost spectrum may function primarily as amplifiers.

“Most of these products are likely to provide some relief, but it is also possible to have an untreated medical condition which, if treated, may solve your problem. Bottom line – to be better informed, it makes sense to consult a professional,” Smith said. “Part of our job as audiologists is not just to test your hearing, but also to advise you on how to manage hearing loss and what products can help you – so that we can help you determine what will work best for you, what might be a waste of money, and how to make an informed purchase.

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

The centers offer competitive pricing and accept all major insurances 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.

For more information or to make an appointment, visit: uri.edu/speech-hearing or call 401.874.5969.


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