Over-the-Counter Hearing Aids: Good News, With Some Complications

Cough syrup, aspirin, toilet paper … and hearing aids. That may be some consumers’ drugstore shopping list this fall, thanks to a new FDA rule making some hearing aids available without a prescription in pharmacies, electronics stores such as Best Buy, and online.

Is that good news or bad news for the 38 million American adults estimated to have trouble hearing?

It depends on whom you ask. Some advocates for those with hearing loss lobbied for the rule change, which they hope will make hearing aids cheaper, easier to get, and less stigmatized. Hearing aid makers are cheering expanded opportunities to market and sell their products.

But audiologists, even those who generally support the idea of non-prescription hearing aids, worry that without an initial evaluation and ongoing care, people will buy the devices without understanding how to use or adjust them. In addition, they won’t know the cause of their hearing loss, which could be triggered by earwax, fluid in the ear or, in rare cases, a tumor requiring surgery.

At the Hearing Loss Association of America, a Maryland-based consumer advocacy group that provides education and support to people with hearing loss who embrace technological fixes (as opposed to those born deaf and who use American Sign Language), Executive Director Barbara Kelley says over-the-counter hearing aids mean “a new pathway to care” for millions of people.

“Eighty percent of people who could benefit from a hearing aid don’t get one,” she says, due to some combination of stigma, denial, cost, and lack of access. They may live in rural areas, far from an audiologist; or they may lack medical insurance that would pay for ongoing hearing health care. “If this makes those devices affordable and accessible, normalizing them, we think it’s a good thing.”

The FDA rule creates a category of hearing aids, available for those over 18 with mild to moderate hearing loss, that can be sold without a prescription, fitting adjustment, or hearing test required.

“I would say it’s not good news,” says Cindy Simon, AuD, an audiologist whose practice, based in South Miami, includes many older patients. “I spend 2 hours dispensing a hearing aid, showing [patients] how to use it, having them come back weekly for 4 weeks to make adjustments.

“Can you imagine going into Walgreen’s, buying a hearing aid, and expecting the girl at the counter to sit down and teach you how to use it?”

Sherrie Davis, AuD, associate director of audiology and the Dizziness & Balance Center at Penn Medicine in Philadelphia, notes that it’s hard for someone to tell whether their hearing loss is mild, moderate, or severe; without a test, there’s no chance to catch other causes of poor hearing – from mild conditions like allergies to more serious ones such as an acoustic neuroma, a benign tumor on the nerves leading from the inner ear to the brain.

Some audiologists fear that consumers could damage their hearing by setting the devices at too high a volume; they advocated for limits on the “gain output” – the difference between the unamplified sound a patient hears and that same sound heard with a hearing aid. The FDA did not include limits on gain, though – in response to some of the more than 1,000 public comments received on the rule – it did cap the maximum sound output of over-the-counter hearing aids at 117 decibels (nearly the level of a jet plane during takeoff).

“We don’t want people putting devices on their ears and causing more hearing loss,” says Tricia Ashby-Scabis, AuD, senior director of audiology practices at the American Speech-Language-Hearing Association, which represents speech pathologists, audiologists, and similar professionals.

For the makers of hearing aids, the FDA rule is cause to celebrate. Gary Rosenblum, president of the hearing aid company Oticon and chair of the Hearing Industries Association, the manufacturers’ group, says making hearing aids available over the counter (OTC) will lower their cost and make them easier to get.

But even he cautions that “over-the-counter hearing aids aren’t necessarily a panacea” and urges that people who buy non-prescription aids should still see a hearing care professional and ask pointed questions about return policies and warranties.

Currently, hearing aids cost anywhere from several hundred to nearly $8,000 per pair, depending on their technological sophistication and the package of “bundled services” that come with an audiologist’s care; those may include a free 30- or 45-day trial, weekly visits for adjustment and questions, and several years of follow-up care.

The current market includes a wide array of hearing aid types – from tiny buds that tuck inside the ear canal to behind-the-ear models with a transparent wire; rechargeable and battery-operated; and hearing aids that sync with a smartphone and can be used with Bluetooth.

“It’s naïve to think people can just buy something, program it, put it on their ear, and have it work for them” says Ashby-Scabis. “I think there needs to be some thought to how we’re going to provide follow-up. I’m not sure [over-the-counter] hearing aids are going to be as simple a fix as was desired.”

She and other audiologists worry that consumers will try an over-the-counter hearing aid, find it frustrating to use on their own, and give up on the devices entirely. “We don’t want people to think, ‘Hearing aids don’t work,’ ” she says.

On a community health level, hearing loss amounts to far more than missed conversation at the dinner table or exasperating phone calls with Grandpa. Untreated hearing loss can lead to isolation, depression, anxiety, a higher risk of dementia, and increased risk of falling.

It’s possible, audiologists suggest, that having hearing aids more visible – right next to the revolving kiosk of over-the-counter reading glasses at your local pharmacy – will raise awareness about hearing health while also reducing negative stereotypes and shame about hearing loss.

That stigma is already changing, they say, because ear buds and Bluetooth devices have gotten more popular; it’s become normal to see people of any age with bits of plastic in their ears.

At the least, say audiologists, the buzz about over-the-counter hearing aids will make hearing loss a less-taboo topic. “Patients say, ‘I hate my hearing aids, and I can’t live without them,’ ” Ashby-Scabis says. “I hope there’s more awareness of the impact hearing loss has on health. I hope we’ll see that change in the years moving forward.”

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