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

Cough syrup, aspirin, toilet paper… and hearing aids. That could be some consumers’ shopping list this fall, thanks to a new FDA rule that makes some hearing aids available over the counter in pharmacies, electronics stores like Best Buy and online.

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

It depends who you ask. Some advocates for people with hearing loss lobbied for the rule change, which they hope will make hearing aids cheaper, more accessible and less stigmatized. Hearing aid manufacturers applaud the extensive opportunities to market and sell their products.

But audiologists, even those who generally support the idea of ​​over-the-counter 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 will not know the cause of their hearing loss, which can be caused 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 organization that provides education and support to people with hearing loss who are embracing technology solutions (as opposed to those who are deaf and use American Sign Language), Executive Director Barbara Kelley says over-the-counter hearing aids represent “a new path 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 a combination of stigma, denial, cost, and lack of access. They may live in rural areas, far from an audiologist; they may not have medical insurance that would pay for ongoing hearing care. “If this makes those devices affordable and accessible and normalizes them, we think that’s a good thing.”

The FDA rule creates a category of hearing aids, available to people over the age of 18 with mild to moderate hearing loss, that can be sold as early as mid-October without the need for a prescription, fitting or hearing test.

“I’d say it’s not good news,” says Cindy Simon, Au.D., whose practice, based in South Miami, includes many elderly patients. “I spend two hours delivering a hearing aid and show that [patients] how to use it, by having them come back weekly for four weeks to make adjustments.

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

Sherrie Davis, Au.D., Associate Director of Audiology and the Dizziness & Balance Center at Penn Medicine in Philadelphia, notes that it is difficult for a person to judge whether their hearing loss is mild, moderate, or severe; minus a test, there’s no chance of discovering other causes of hearing loss — from mild conditions like allergies to more serious ones like an acoustic neuroma, a benign tumor on the nerves that run from the inner ear to the brain.

Some audiologists fear that consumers could damage their hearing by using the devices at too high a volume; they argued for limits on “gain output” – the difference between the unamplified sound a patient hears and the same sound heard with a hearing aid. However, the FDA has not included limits on gain — in response to some of the more than 1,000 public comments received about the rule — it has capped the maximum sound output of OTC hearing aids to 117 decibels (almost the level of a jet aircraft during to take off).

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

For hearing aid makers, the FDA rule is cause for celebration. Gary Rosenblum, president of the hearing aid company Oticon and president of the Hearing Industry of America, the manufacturers association, says making hearing aids available over-the-counter (OTC) will reduce costs and increase accessibility.

But even he warns that “over-the-counter hearing aids are not necessarily a panacea” and urges people who purchase non-prescription hearing aids to consult a hearing care professional and ask specific questions about return policies and warranties.

Currently, hearing aids cost between hundreds and nearly $8,000 per pair, depending on their technological sophistication and the package of “bundled services” that come with an audiologist’s care; those can include a 30- or 45-day free trial, weekly visits for adjustments and questions, and several years of aftercare.

Today’s market includes a wide range of hearing aid types – from small plugs that are inserted into the ear canal to behind-the-ear models with a transparent wire; rechargeable and battery operated; hearing aids that synchronize with a smartphone and have Bluetooth.

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

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

On a social health level, hearing loss is much more than a missed conversation at the dinner table or annoying phone calls with grandpa. Untreated hearing loss can lead to isolation, depression, anxiety, an increased incidence of dementia and an increased risk of falls.

It’s possible, audiologists suggest, that making 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 reducing negative stereotypes and embarrassment about hearing loss.

That stigma is already changing, they say, due to the popularity of earbuds and Bluetooth devices; it has become normal to see people of all ages with bits of plastic in their ears.

At the very least, audiologists say, 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,'” says Ashby-Scabis. “I hope there is more awareness about the impact hearing loss has on health. I hope we see that change in the coming years.”