Cough syrup, aspirin, toilet paper … and hearing aids. That might be the drugstore shopping list for consumers this fall, thanks to a new Food and Drug Administration rule that makes certain hearing aids available over-the-counter at drugstores and electronics stores like Best Buy and online.
Is this good news or bad news for the 38 million American adults with hearing problems?
This depends on who you ask. Some advocates for those with hard of hearing have lobbied for a change in the rule, which they hope will make hearing aids cheaper, more accessible, and less stigmatizing. Hearing aid manufacturers rejoice at the 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 initial evaluation and ongoing care, people will buy the devices without understanding how to use or modify 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 that requires surgery.
At the American Hearing Loss Association, a Maryland-based consumer advocacy group that provides education and support for hard of hearing people who adopt technology solutions (as opposed to those who are born deaf and who use American Sign Language), CEO Barbara Kelly says over – Over the counter hearing aids mean a “new path of 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, disadvantage, cost, and lack of access. They may live in rural areas, far from the audiologist; They may lack medical insurance that would pay for ongoing hearing health care. “If that makes these devices affordable, accessible, and normalized, we think it’s a good thing.”
The FDA rule creates a class of hearing aids, available to those over 18 with mild to moderate hearing loss, that can be sold — as early as mid-October — without the need for a prescription, appropriate modification or hearing test.
“I would say it’s not good news,” says Cindy Simon, Australia, which is based in south Miami and has many older patients. “I spent two hours laying out an earpiece, and it showed [patients] How to use it, and have them come back weekly for four weeks to make adjustments.
“Can you imagine going to Walgreen, buying a hearing aid and expecting the girl to sit at the table and teach you how to use it?”
Sherry Davis, MD, associate director of audiology and the Center for Dizziness and Balance at Penn Medicine in Philadelphia, notes that it is difficult for an individual to assess whether their hearing loss is mild, moderate, or severe. Put to the test, there’s no chance of learning about other causes of hearing loss – from mild cases like allergies to more serious ones like acoustic neuroma, a benign tumor of nerves that extends from the inner ear to the brain.
Some audiologists fear that consumers may harm their hearing by setting devices at a volume that is too high; They advocated a limitation on “output gain” – the difference between the unamplified sound heard by a patient and the same sound heard using a hearing aid. The Food and Drug Administration did not include gain restrictions, though—in response to some of the 1,000-plus public comments received on the base—it limited the maximum sound output of out-of-cabin hearing aids to 117 decibels (roughly the level of a jet plane during take off).
Says Tricia Ashby Scapes, Au.D. , Senior Director of Audiology Practices for the American Speech-Language Hearing Association, which represents speech-language pathologists, audiologists and similar professionals.
For hearing aid makers, the Food and Drug Administration (FDA) rule is cause for celebration. Gary Rosenblum, president of the Oticon hearing aid company and president of the Hearing Industry of America, the association of manufacturers, says making over-the-counter (OTC) hearing aids lower their cost and enhance their accessibility.
But he also cautioned that “over-the-counter hearing aids are not necessarily a panacea” and urges people who buy over-the-counter aids should continue to see a hearing care professional and ask specific questions about return policies and warranties.
Currently, hearing aids cost anywhere from several hundred to nearly $8000 per pair, depending on their technological sophistication and the “bundled services” package that comes with your audiologist’s care; This may include a 30- or 45-day free trial, weekly adjustment and questions visits, and several years of follow-up care.
The current market includes a wide range of types of hearing aids – from small buds that are bent inside the ear canal to models that are placed behind the ear with a transparent wire. rechargeable and battery operated; Hearing aids that sync with a smartphone and have Bluetooth functionality.
“It’s naive to think that people can buy something, program it, put it on their ears, and have it work for them,” Ashby Scapes says. “I think there should be some thought on how to deliver the follow-up. I’m not confident [over-the-counter] Hearing aids will be a simple fix as to be desired.”
Ashby Scapes and other audiologists worry that consumers will try over-the-counter hearing aids, find it frustrating to use them on their own and give up the devices altogether. “We don’t want people to think, ‘Hearing devices don’t work,'” she says.
On a community health level, hearing impairment amounts to much more than missed conversations at the dinner table or silly phone calls with grandpa. Untreated hearing loss can lead to isolation, depression, anxiety, an increased rate of dementia, and an increased risk of falls.
Audiologists suggest that having more visible hearing aids — next to the rotating kiosk of over-the-counter reading glasses at your local pharmacy — will increase awareness about hearing health while reducing negative stereotypes and shame about hearing loss.
They say this stigma is already changing due to the popularity of earbuds and Bluetooth devices; It has become normal to see people of any age with pieces of plastic in their ears.
At least, audiologists say, the hype around over-the-counter hearing aids will make hearing loss a less taboo subject. “Patients say, ‘I hate my hearing aids, I can’t live without them,'” Ashby Scapes says. “I hope there will be more awareness of the impact of hearing loss on health. I hope to see this change in the coming years.”