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, are concerned that without initial assessment and ongoing care, people will fail to understand how to use or adjust them without purchasing these devices. In addition, they did not know the cause of hearing loss, which could be caused by earwax, fluid in the ear, or, in rare cases, a tumor that required surgery.
The Hearing Loss Association of America, a Maryland-based consumer advocacy organization that educates and supports people with hearing loss undergoing technological repair (not those people born deaf and using American Sign Language), executive director Barbara Kelley said over-the-counter hearing aids mean “a new pathway to care” for millions of people.
“80% of people who could benefit from hearing aids don’t ‘not get one,'” she said — 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 it’s a good thing. “
FDA rules have created a category of hearing aids for use by people over the age of 18 with mild to moderate hearing loss, available as early as mid-October, No prescriptions, fittings or hearing tests are required.
“I would say it’s not good news,” said Cindy Simon of Au.D., whose practice in South Miami includes many elderly Patients. “I spent two hours dispensing hearing aids, showing [patients] how to use it, and having them come back every week for four weeks of adjustments.
“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 the Center for Audiology and Dizziness and Balance at the Pennsylvania School of Medicine in Philadelphia, noted that it is difficult for individuals to assess whether their hearing loss is mild, moderate, or mild Severe; minus testing, 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 are concerned that consumers can damage their hearing by setting the device too high; The difference between the same sounds heard by hearing aids. 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, MD, Australian., American Speech- Senior Director of Audiology Practice at the Speech-Language-Hearing Society, which represents speech pathologists, audiologists and similar professionals.
For hearing aid manufacturers, FDA regulations are 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 warns that “over-the-counter hearing aids are not necessarily a panacea” and urges people who buy over-the-counter hearing aids to still see a hearing care professional and ask tough questions About Return Policy and Warranty.
Currently, hearing aids range in price from hundreds to nearly $8,000 per pair, depending on their technical sophistication and the “bundled service” package that comes with the audiologist’s Care; which 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 earplugs that fit in the ear canal to behind-the-ear model; rechargeable and battery powered; hearing aid that syncs with a smartphone and has Bluetooth.
“The idea that people can buy something, program it, put it on their ear and make it work is naive. They” Ashby-Scarby said. “I think there’s a need to think about how we’re going to provide follow-up. I’m not sure [over-the-counter] hearing aids will be as simple as expected.”
Ashby-Scabis and other audiologists worry Consumers will try over-the-counter hearing aids, find themselves frustrating to use 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 grandpa. Untreated hearing loss can lead to isolation, depression, anxiety, increased incidence of dementia, and increased risk of falls.
Audiologists recommend making hearing aids more visible – just Next to a rotating kiosk for over-the-counter reading glasses 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 prevalence of earbuds and Bluetooth devices; it is normal to see plastic debris in the ears of people of any age.
At least, audiologists say, the buzz about over-the-counter hearing aids can 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 can see this change in the years to come.”