OTC Hearing Aids Offer the Same Benefit as Audiologist-Fitted Devices, Study Finds

A JAMA article reports that OTC devices, which are a fraction of the price, perform the same as traditional units after eight months.

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Self-fitted over-the-counter hearing aids offer the same long-term benefit as devices fitted by audiologists, but at a quarter of the cost, according to a new study.

The study in the Journal of the American Medical Association, Otolaryngology–Head & Neck Surgery, builds on a study published in JAMA in April 2023. The previous report showed that after six weeks of use, self-fitted Lexie Lumen OTC hearing aids gave people the same benefit as those fitted by an audiologist. According to the updated research, users of OTC and audiologist-fitted hearing aids experienced similar benefits after eight months.

OTC hearing aids have expanded Americans’ access to hearing care because they typically are less than a quarter of the price of audiologist-fitted devices and can be bought and fitted at home, saving wearers the time and expense of audiologist appointments.

Half of the participants in the trial received Lexie Lumen hearing aids, which are available for purchase online and at stores, and were instructed to self-fit them. The other half were given the same hearing aids fitted by an audiologist. After two weeks, OTC wearers received access to Lexie remote support for fine tuning. Those with the audiologist-fitted hearing aids were provided support and fine-tuning from an audiologist.

After eight months, the benefits of self-fitted OTC hearing aids and audiologist-fitted hearing aids showed no statistically significant difference.

“The results of this study hold great promise for the tens of millions of Americans living with untreated mild to moderate hearing loss,” said De Wet Swanepoel, Ph.D., one of the study authors. “Hearing loss is chronically undertreated, in part because of the expense and inconvenience of prescription hearing aids. With clinical proof that OTC products produce the same long-term benefit, we believe more people can and will confidently take steps to address hearing loss so they can live longer, healthier lives.”

The FDA approved a new category of self-fitting hearing aids to be sold over the counter by retailers across the U.S. in 2022.

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