FDA Proposes Plan to Make Hearing Aids Available Over the Counter

People with mild to moderate hearing loss may soon be able to get hearing aids over the counter.

Last week, the Food and Drug Administration issued a proposal to allow hearing aids to be sold directly to consumers, without a medical exam or fitting by an audiologist.

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The proposed rule would implement a provision in the 2017 Over-the-Counter Hearing Aid Act, which requires the FDA to create a category for OTC hearing aids, and corresponding regulations. Currently, hearing aids are regulated as prescription medical devices, which require medical exams and help from audiologists.

The proposal is currently in the 90-day public comment period, though no timeline has been announced.

“We are very thrilled that the proposed rules come out ... We are reviewing them. We are looking through the consumer eye, the patient eye,” said Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer group which has a chapter in Chicago. The organization says it plans to submit its comments within the 90-day period.

About 37.5 million American adults have difficulty hearing, but only one in five people who need hearing aids have them, according to the FDA.

One barrier is the cost of hearing aids, and some say this legislation could lower the financial burden. Hearing aids can range from about $1,000 to $5,000, and they aren’t always covered by insurance.

The hearing aid itself can typically be just one-third of the total cost a person pays, Kelley said. The rest of the price tag covers fittings and follow up appointments. Those services are important, Kelley said, but self-fitting and OTC hearing aids might make some more likely to get hearing aids.

Audiologist Mike Sharp said the proposal could help bring the cost of hearing aids down but might pose challenges for people who aren’t as familiar with technology.

“The upside is that for people who are very tech savvy, who can work via troubleshooting online, this actually could be a very good option for them ... The one downside is that potentially you don’t have a professional to work with if something goes wrong,” Sharp said. He is also the vice president of audiological affairs at the Illinois Speech-Language Hearing Association.

Another upside could be that OTC hearing aids could encourage people to get hearing aids sooner, Sharp said.

“For a person who needs hearing devices, the average time a person with a hearing loss waits before getting a device is seven years. So, what the OTC could really mean is that people might be entering the hearing aid market earlier,” Sharp said. “Starting on that journey a little bit earlier in the time frame could be really beneficial for some people.”

Untreated hearing loss can lead to isolation and comorbidities, like falls, Kelley said.

“Now there is research being done on the cognitive link between untreated hearing loss that’s linked to a cognitive decline. So hearing health is really a part of staying fit, staying engaged and staying active,” Kelley said.

While traditional hearing aids aren’t accessible over the counter, “personal sound amplification products” known as PSAPs are. These devices aren’t allowed to be marketed as hearing aids, instead as a way for people with normal hearing to increase volume. They’re also not regulated. However, some turn to PSAPs as alternatives to hearing aids.

“The OTCs would be FDA regulated devices, so there would be more guard rails as far as the device, what it can do and what it is capable of,” Sharp said.

Cost isn’t the only barrier to accessing hearing aids. Stigma and access to care can impact this too, Kelley said.

“If somebody thinks they have a hearing loss, don’t wait for the over-the-counter hearing aid market to open up, get your hearing checked now, find out what your situation is and what your options might be,” Kelley said.

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