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Cough syrup, aspirin, toilet paper… and hearing aids. That could be on some drugstore consumers’ shopping lists this fall, thanks to a new FDA rule making 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 disabilities?

It depends who you ask. Some advocates for people with hearing loss have lobbied for the rule change, which they hope will make hearing aids cheaper, more accessible and less stigmatizing. Hearing aid manufacturers are excited about increased 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 fit them. They also don’t know the cause of their hearing loss, which can be caused by earwax, fluid in the ear or, in rare cases, a tumor that has been operated on.

At the Hearing Loss Association of America, a Maryland-based consumer advocacy group that provides education and support to people with hearing loss who choose technology solutions (as opposed to those who were born deaf and use American Sign Language), says executive director Barbara Kelley -The-Counter hearing aids mean “a new way of caring” 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, rejection, cost and lack of access. You may live in rural areas far from an audiologist; They may lack medical insurance that would pay for ongoing hearing health care. “If this makes these devices affordable and accessible and normalizes them, we think that’s a good thing.”

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

“I would say that’s not good news,” says Cindy Simon, Au.D., whose South Miami practice includes many older patients. “I spend two hours giving out and showing a hearing aid [patients] how to use it by coming back weekly for four weeks to make adjustments.

“Can you imagine walking 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, 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 assess whether their hearing loss is mild, moderate, or severe; Without a test, there’s no chance of detecting other causes of poor hearing — from minor conditions like allergies to more serious ones like acoustic neuroma, a benign tumor on the nerves that lead from the inner ear to the brain.

Some audiologists worry that consumers could damage their hearing by turning the devices up too loud; 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. The FDA hasn’t included gain limits, although — in response to some of the more than 1,000 public comments received on the rule — it has capped the maximum sound output of OTC hearing aids to 117 decibels (almost the volume of a jet plane during of hearing). take off).

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

For hearing aid manufacturers, the FDA rule is cause for celebration. Gary Rosenblum, president of hearing aid manufacturer Oticon and chairman of the Hearing Industry of America manufacturers’ association, says making hearing aids available over-the-counter (OTC) will lower their costs and improve accessibility.

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

Hearing aids currently range in price from several hundred to nearly $8,000 per pair, depending on their technological sophistication and the package of “bundled services” that come with the care of an audiologist. These may include a 30- or 45-day free trial, weekly visits for fitting and questions, and multi-year follow-up care.

The current market includes a wide range of hearing aid types – from tiny buds that are placed in the ear canal to behind-the-ear models with a transparent cable; rechargeable and battery operated; Hearing aids that sync to a smartphone and are Bluetooth enabled.

“It’s naïve to think that people can just buy something, program it, put it in their ear and let it work for them,” says Ashby-Scabis. “I think we need to think about how we’re going to do the follow-up. I’m not sure [over-the-counter] Hearing aids will be as simple as desired.”

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

In terms of health policy, hearing loss means much more than missed conversations 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.

According to audiologists, it’s possible hearing aids that are more visible — right next to the revolving kiosk selling over-the-counter reading glasses at your local pharmacy — can raise awareness about hearing health while reducing negative stereotypes and shame 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 excitement surrounding 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 that there will be more awareness of the health impact of hearing loss. I hope we will see this change in the years to come.”



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