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Medicare does not cover hearing aids; neither do most insurance policies. That’s why advocates welcome a new federal rule allowing over-the-counter devices to be sold, hoping the move will lower prices and make it easier for people with hearing loss to improve their lives.
In mid-October, consumers could see over-the-counter devices in pharmacies that are much more affordable than prescription aids that routinely cost thousands of dollars, thanks to the Food and Drug Administration rule. announced tuesday. But many people will likely have to bear this cost on their own – and this is just one of the challenges that people with hearing loss still face.
“We’re really excited about the market,” said Barbara Kelley, executive director of the Hearing Loss Association of America. But, she added, “we think it’s going to be confusing for consumers.”
Here’s a look at why the rule is celebrated and what issues remain.
The new rule is a long-awaited breakthrough
“There are 48 million people in this country with some degree of hearing loss,” Kelley told NPR, “and there is no small hearing loss. It can completely disrupt your life.”
The new rule’s promise to minimize a host of health problems was hailed by Dr. Debara Tucci, director of the National Institute on Deafness and Other Communication Disorders.
“Hearing loss is associated with dementia, increased risk of falls, reduced mobility, depression, social isolation and anxiety,” Tucci said. said on the website of his federal agency.
Wearing hearing aids can make a big difference. As the Hearing Industries Association stated in an email to NPR, “8 out of 10 people who have chosen to treat their hearing loss report life-changing results.”
Prescription hearing aids are often very expensive
“The FDA estimates that this rule will save consumers about $1,400 per individual hearing aid or more than $2,800 per pair,” said Brian Deese, director of the National Economic Council, said of the new FDA rule.
This is a substantial saving for an essential item that the Hearing Industries Association said can range from less than $1,000 to $4,000 each.
The industry group notes that the actual devices are typically only about a third of the total cost, as the process of getting a prescription hearing aid normally includes many visits to doctors and specialists who assess patients and adjust , test and adjust their hearing aids.
Over-the-counter aids could compete with PSAP devices
By creating a new category of products, the FDA is offering a regulated alternative to people who, in recent years, might have turned to PSAP — or personal sound amplification products.
PSAPs are promoted as a way to amplify a normal person’s hearing. But many of the people who buy them aren’t hunters or private investigators – they just have trouble hearing, whether in person or when watching TV.
With the change, the PSAP category will still exist, but if their manufacturers want to sell a device as an OTC hearing aid, they will have to meet FDA quality and labeling standards.
“The truth is, in this category there are some really good devices that will make it into the over-the-counter market and meet the criteria,” Kelley said. “The difference is that they can now market them to people with hearing loss.”
Medicare does not pay for hearing aids
“Medicare does not cover hearing aids or hearing aid fitting exams,” the government program says. website states. “You pay 100% of the cost of hearing aids and exams.”
Many Americans might be surprised that the federal insurance program doesn’t offer help to those most likely to need hearing aids. But that’s by design.
“When the law was enacted in 1965, not only were hearing aids not there, they were legally excluded,” Kelley said.
Other components of modern insurance, such as dental and vision coverage, were also excluded from the original law – although under the current system some Medicare Advantage plans include coverage for these costs.
Kelley says several ideas are behind the exclusion, including a belief in 1965 that issues like hearing loss weren’t major health concerns. The average lifespan in the United States was also shorter – and as we now live longer, many of us do so in noisier environments that gradually impair our ability to hear.
Lawmakers have made progress in including hearing aids in Medicare coverage in recent years, but a Invoice approved by the house in 2019 failed to advance to the Senate. Attempts to include the requirement in the Democrats’ Build Back Better framework have also failed.
Using hearing aids isn’t as easy as putting on reading glasses
The new class of over-the-counter hearing aids are intended to help adults with mild to moderate hearing loss. But for anyone who thinks buying an OTC hearing aid will help them as easily as a pair of cheap reading glasses will improve their eyesight, Kelley warns it’s not that simple.
“It’s a good analogy,” she said, “except I’d like to clarify that when we put on glasses, they usually correct our vision. When you put on a hearing aid, it doesn’t always correct your hearing. .”
This is because many cases of hearing loss are highly individualized, with issues related to specific frequencies or environments.
“Hearing loss is unique to each person, and most don’t know if their condition is mild, moderate or more severe, caused by another medical condition or something as simple as earwax,” said the president of the Hearing Industries Association, Kate Carr, in an emailed statement. .
While many people might benefit from an over-the-counter product, others might need to see a doctor and audiologist for more sophisticated care, according to Carr and others.
The possibility that some consumers may rely on trial and error to find a device that works well for them has led some commentators on the FDA proposal to ask the agency to ensure they can easily return or exchange over-the-counter hearing aids. The FDA declined to do so, citing existing consumer laws. But it’s final rule requires manufacturers to clearly state their return policies.
If you are purchasing a hearing aid without a prescription, the Hearing Industries Association recommends keeping your receipt and knowing the device’s warranty and return details. He also cautions consumers against using devices that over-amplify sound, as too high a volume could further damage their hearing.
The rule responds to a mandate set in 2017
Despite Medicare’s coverage limit, the OTC rule is a long-awaited victory, coming five years after Congress voted in 2017 to require the FDA to create an OTC category for hearing aids.
Regulators were spurred to act last summer when President Biden released a sweeping executive order to promote more competition. He tasked the Department of Health and Human Services with proposing a rule on over-the-counter hearing aids, setting a new timetable in motion.