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What to know about FDA allowing over-the-counter sale of hearing aids

WATE Knoxville logo WATE Knoxville 11/29/2022 Hope McAlee
What to know about FDA allowing over-the-counter sale of hearing aids © Provided by WATE Knoxville What to know about FDA allowing over-the-counter sale of hearing aids

KNOXVILLE, Tenn. (WATE) - Those looking to purchase over-the-counter hearing aids should keep a few things in mind before purchasing according to the Tennessee Attorney General’s Office.

In August, the U.S. Food and Drug Administration (FDA) issued a final rule establishing over-the-counter (OTC) sales of hearing aids for consumers over the age of 18 to improve access to safe, effective, and affordable hearing aids. This decision the FDA says does not require a medical exam, prescription, or a fitting adjustment by an audiologist. Most recently, the FDA issued additional guidance, cautioning consumers about the difference between OTC hearing aids and Personal Sound Amplification Products (PSAP).

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While both may be available in similar stores, the FDA says PSAPs are intended for people of any age and normal hearing to amplify sounds in certain environments, such as bird watching or hunting, and do not have FDA requirements regarding conditions for sale. PSAPs are not medical devices the FDA says. OTC hearing aids, on the other hand, are intended only for adults ages 18 and older with perceived mild to moderate hearing loss and are a medical device, according to the FDA.

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For those considering purchasing OTC hearing aids, Tennessee Attorney General Jonathan Skrmetti’s office says that consumers should carefully read return policies and be cautious of low prices. The key point Skrmetti’s office says to keep in mind are:

  • The refund policy – “Look for the seller with the longest return timeframe. You may need a couple of weeks to adjust to a hearing aid. Getting the technical support needed to calibrate the hearing aid to your hearing loss may take some time.” Skrmetti’s office said.
  • Money back guarantees – “Understand the process for getting your money back. Do you have to use a particular shipping service? Who makes the determination that you returned the devices in satisfactory condition? Is there a restocking fee? What if you accept an alternate or upgraded device in exchange for the original device and decide that you do not want the alternate one? Will the company policy let you return the alternate? Be wary of a refund policy that seems unclear or unnecessarily complicated.” Skrmetti’s office said.
  • Prices – “Often, a consumer can find the same product at varying prices. You may be able to find the same product sold by a different seller with free shipping and a reliable return or refund policy. Make sure you are not being sold a cheap import that has been re-branded at a high markup price.” The Attorney General’s office said.
  • Reviews – “Some internet reviewers are paid for their reviews and may inflate their opinion of a product as part of their relationship to the hearing aid brand. Many other sites may appear to be scientific and reliable, but function as an infomercial for a specific company.” The Attorney General’s office said. “Pay attention to what brands are being advertised or promoted on what appears to be an independent site. Better Business Bureau ratings provide helpful insight, but consumers should be cautious about relying on highly positive reviews when choosing a product.”
  • Expert advice – “Licensed hearing specialists may be willing to help consumers find the right OTC hearing aid. They may help with consultations, fittings, and adjustments. Beware of online self-tests some vendors may offer that recommend their top-of-the-line device to every person that completes the test.” Skrmetti’s office said.
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The Attorney General’s office added that OTC hearing aids are intended for adults with mild-to-moderate hearing loss and that children under the age of 18 and adults with severe hearing loss should consult a licensed hearing specialist for appropriate hearing assistance device.

Those who believe they have experienced consumer fraud can file a consumer complaint by visiting this website, the Tennessee Attorney General said. The Attorney General’s Division of Consumer Affairs in Nashville can also be reached at (615) 741-4737 for consumer inquiries or to request a complaint form.

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