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Over-the-Counter Hearing Aids Are as Effective as Prescription Devices, Study Finds

For those who have mild to moderate hearing loss, self-fitting hearing aids work as well as ones fitted by audiologists

spinner image man blurred in background holding up an over-the-counter hearing aid in foreground
A new study looks at the effectiveness of over-the-counter hearing aids. Here, Sterling Sheffield, an audiologist and professor at the University of Florida who was not involved in the study, holds one of the new devices.
Alan Youngblood/AP Newsroom

Last year, many experts heralded the arrival of over-the-counter hearing aids, predicting that they would make the devices more affordable and accessible to millions of Americans. But the big question was: could over-the-counter hearing aids work as well as those fitted by an audiologist?

Now, the first randomized, controlled study designed to answer that question indicates the answer is yes.

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The study, published April 13 in JAMA Otolaryngology-Head & Neck Surgery, assigned 64 adults with mild to moderate hearing loss to either an over-the-counter hearing aid they had to adjust themselves or the same hearing aid fitted by an audiologist.

After six weeks, the self-fitted hearing aids were as effective as the audiologist-fitted devices, the research showed.  

Though the trial was small, it is significant because it demonstrates that patients can successfully adjust the settings of a hearing aid without the help of an audiologist, says Nicholas Reed, an audiologist and assistant professor at Johns Hopkins University Bloomberg School of Public Health, who was not involved in the study.

“That these subjects – older adults with a mean age of 63 – were as successful as their peers who saw an audiologist, that’s a very significant takeaway about the viability of these over-the-counter devices,” Reed says. “This shows us that you can basically hand someone this product, and they can improve their hearing.” Reed and Frank Lin, MD, are co-authors of AARP's Hearing Loss for Dummies.

Study helps quell concerns but has limitations

The Food and Drug Administration gave the green light to over-the-counter hearing aids last year, and they first came on the market in October 2022.

Designed for those who have mild to moderate hearing loss, the devices are much less expensive than prescription options. The FDA has said that consumers can expect to save about $2,800 per pair.

Yet consumers and audiologists alike have been somewhat wary. A January 2023 survey found that 84 percent of consumers were uncomfortable with the idea of using an over-the-counter device.

“Anytime there is a direct-to-consumer moment in health care, there is always a lot of hesitation,” says Vinaya Manchaiah, a professor of otolaryngology at the University of Colorado School of Medicine and director of audiology at the University of Colorado Hospital.

Manchaiah, who co-authored the JAMA Otolaryngology study, said he and his fellow researchers wanted to publish their results quickly to address those concerns, but he acknowledged that a study limitation is the lack of long-term data.


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They are continuing to monitor the study subjects and will publish updated results after six months, Manchaiah says. The study was funded by the hearing aid manufacturer.

Reed says it’s not unusual for problems with a hearing aid to crop up after the six-week mark. Most over-the-counter devices have some type of online support. Reed notes that you could also always see an audiologist to help you solve issues with an over-the-counter device after you buy it.

“A professional may still play a role even if they’re not needed up front,” he says.

Advice for hearing aid consumers

Another limitation of the study, Reed says, is that it looked at only one type of over-the-counter device: Lexie Lumen hearing aids, which retail for about $800 a pair.

“This is good technology. It’s smartphone integrated, and it allows some very deep fine-tuning,” Reed says. “The over-the-counter market is not going to shake out with only these kinds of devices. There will be good over-the-counter devices and bad over-the-counter devices.”

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If you’re shopping for an over-the-counter hearing aid, Reed recommends looking for a product that is labeled “self-fitting,” which indicates a more sophisticated device with customizable settings.

In addition, you should consider getting an assessment from a certified audiologist before you buy, says Lindsay Creed, associate director of audiology practices at the American Speech-Language-Hearing Association.

“This testing is almost always covered by insurance and will determine if the individual is a good candidate for over-the counter hearing aids, including ruling out any ear-related medical conditions,” she says.

Creed and other experts say they look forward to more research on over-the-counter hearing aids, including studies that investigate which types of patients are most likely to benefit.

One 2017 study that came out before over-the-counter hearing aids were available found a benefit from seeing an audiologist. In the earlier study, published in the American Journal of Audiology, researchers found that those who tried a device without a fitting from an audiologist were not as happy with the process as a group who had help from an audiologist fitting the same device. The study found, however, that the hearing of both groups was helped by the hearing aids. (A placebo group with a device that didn’t have amplification were, not surprisingly, not helped.)

For now, Reed says, if you don’t like the idea of adjusting and setting up a device yourself, by all means, go to an audiologist. But he says if you are comfortable with technology, your hearing loss is not severe and you want to save some money, why not try an over-the-counter option? (Find out How to Shop for Over-the-Counter Hearing Aids​)

“This study is helping me and everyone else believe that with these self-fit ones, you’re not going to do any worse than you would having an audiologist fit the device,” Reed says. “This is building trust.”

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