Cough syrup, aspirin, toilet paper… and hearing aids. That could be on some consumers’ pharmacy shopping list this fall, thanks to a new FDA rule that makes some hearing aids available without a prescription at pharmacies, electronics stores like Best Buy and online.
Is this good news or bad news for the estimated 38 million American adults with hearing impairment?
It depends on who you ask. Some advocates for the hearing-impaired are lobbying for the rule change, which they hope will make hearing aids cheaper, more accessible and reduce stigma. Hearing aid makers are cheering for expanded 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 these devices without understanding how to use or adjust them. Also, they don’t know the cause of hearing loss, which can be caused by earwax, fluid in the ear, or, in rare cases, a tumor that requires surgery.
Barbara Kelley, executive director, said the American Hearing Loss Association, a Maryland-based consumer advocacy group, educates and supports people with hearing loss who receive technological repairs (rather than those who are born deaf. and those using American Sign Language) – Over-the-counter hearing aids mean a “new pathway to care” for millions.
“Eighty percent of the people who could benefit from hearing aids 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 audiologists; they may lack health insurance that can pay for ongoing hearing care. “If this makes these devices affordable and easy to use and normalizes them, we think that’s a good thing.”
FDA regulations have created a class of hearing aids for people over 18 with mild to moderate hearing loss, available as early as mid-October without a prescription, fitting or hearing test.
“I would say it’s not good news,” said Cindy Simon of South Miami, Australia, whose practice includes many elderly patients. “It took me two hours to dispense hearing aids and it showed [patients] How to use it, keep them coming back every week for four weeks to adjust.
“Can you imagine walking into Walgreens, buying a hearing aid, and expecting the girl at the counter to sit down and teach you how to use it?”
Sherrie Davis, Au.D., associate director of audiology, Dizziness and Balance Center at the University of Pennsylvania Medical Center in Philadelphia, noted that it is difficult for individuals to assess whether their hearing loss is mild, moderate, or severe. Subtract testing and there’s no chance of finding other causes of hearing loss — from mild conditions like allergies to more serious conditions like acoustic neuromas, benign tumors on the nerves that run from the inner ear to the brain.
Some audiologists worry that consumers setting the device too high could damage their hearing. They advocate limiting the “gain output” — the difference between the unamplified sound a patient hears and the same sound heard with a hearing aid. The FDA didn’t include a gain limit, though—as some of the more than 1,000 public comments it received about the rule—and it did limit the maximum sound output of OTC hearing aids to 117 decibels (nearly the amount of a jet plane at the time). level) take off).
“We don’t want people to put devices on their ears and cause more hearing loss,” said Tricia Ashby-Scabis, senior director of the Audiology Practice at the American Speech-Language-Hearing Association, which represents speech-language pathologists, audiologists and similar professional.
For hearing aid makers, the FDA regulation is cause for celebration. Offering over-the-counter (OTC) hearing aids will reduce their cost and increase accessibility, said Gary Rosenblum, president of hearing aid company Oticon and president of the American Hearing Industry Association of Manufacturers.
But even he warned that “over-the-counter hearing aids are not necessarily a panacea” and urged people who buy over-the-counter hearing aids to still see a hearing care professional and ask tough questions about return policies and warranties.
Currently, hearing aids cost anywhere from a few hundred dollars to nearly $8,000 per pair, depending on their technical sophistication and the “bundled services” packages offered by audiologists. These may include a 30- or 45-day free trial, weekly visits to adjust and ask questions, and years of follow-up care.
The current market includes a wide variety of hearing aid types—from tiny earbuds that fit into the ear canal to behind-the-ear models with clear wires; rechargeable and battery-powered; hearing aids that sync with smartphones and have Bluetooth capabilities.
“The idea that people can buy something, program it, put it on their ear and have it work for them is naive,” Ashby-Scabis said. “I think there needs to be some thought about how we’re going to provide follow-up. I’m not sure. [over-the-counter] Hearing aids will be as simple as one would hope. “
Ashby-Scabis and other audiologists worry that consumers will try over-the-counter hearing aids, find themselves frustrating to use them and abandon the devices altogether. “We don’t want people to think, ‘Hearing aids don’t work,'” she said.
On a community health level, hearing loss far outnumbers missed dinner table conversations or annoying phone calls with grandfathers. Untreated hearing loss can lead to isolation, depression, anxiety, increased incidence of dementia, and increased risk of falls.
Audiologists suggest that making hearing aids more visible — right next to the over-the-counter reading glasses rotating kiosk at your local pharmacy — may increase awareness of hearing health, while also reducing negative stereotypes and stigma about hearing loss.
They say that stigma has changed due to the popularity of earbuds and Bluetooth devices. It is normal to see plastic debris in the ears of people of any age.
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, I can’t live without them,'” Ashby-Scabis said. “I hope people are more aware of the health effects of hearing loss. I hope we’ll see this change in the next few years.”