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Medicare does not cover hearing aids; most insurance policies do not. That’s why proponents welcome a new federal rule that allows the sale of the devices without a prescription, in hopes that the move will lower prices and make it easier for people with hearing loss to improve their lives.
By mid-October, consumers could see over-the-counter devices in drugstores that are much cheaper than prescription devices that routinely cost thousands of dollars, thanks to the rule the Food and Drug Administration announced Tuesday. But many people will likely have to bear those costs on their own — and that’s just one of the challenges people with hearing loss still face.
“We’re very excited about the market,” said Barbara Kelley, executive director of the Hearing Loss Association of America. But, she added, “we think it will be confusing for consumers.”
Here’s an overview of why the rule is being celebrated and what issues still 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 such thing as a minor hearing loss. It can completely disrupt your life.”
The new rule’s promise to minimize a host of health problems was praised 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, impaired mobility, depression, social isolation and anxiety,” Tucci said on her federal agency’s website.
Wearing hearing aids can make a big difference. As the Hearing Industries Association said in an email to NPR, “8 in 10 who chose 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, of the new FDA rule.
That’s a significant savings for an essential item that the Hearing Industries Association says can range from less than $1,000 to $4,000 apiece.
The industry group notes that the actual devices usually only make up about a third of the total cost, as the process of getting a prescription hearing aid normally involves numerous visits to doctors and specialists who evaluate patients and fit, test and test their hearing aids. fine tune.
OTC tools can compete with PSAP devices
By creating a new product category, the FDA is offering a regulated alternative to people who may have turned to PSAPs — or personal sound reinforcement products — in recent years.
PSAPs are promoted as a way to enhance a normal person’s hearing. But many of the people who buy them aren’t hunters or private investigators — they just have a hard time hearing, whether it’s in person or when they’re watching TV.
With the change, the PSAP category will still exist, but if their makers want to sell a device as an OTC hearing aid, they must meet FDA quality and labeling standards.
“The truth is, there are some very good devices in that category that will move into the over-the-counter market and meet the criteria,” Kelley said. “The difference is they can now sell them to people with hearing loss.”
Medicare doesn’t pay for hearing aids
“Medicare does not cover hearing aids or hearing aid fitting exams,” the government program’s website states. “You pay 100% of the costs for hearing aids and exams.”
Many Americans may be surprised that the federal insurance program does not provide assistance to people most likely to need hearing aids. But it’s by design.
“When the law went into effect in 1965, hearing aids not only weren’t there, they were outlawed by law,” Kelley said.
Other components of modern insurance, such as dental and vision coverage, were similarly omitted from the original law — although in the current system, some Medicare Advantage plans include coverage for those costs.
Kelley says there are several ideas behind the exclusion, including the 1965 belief that problems such as hearing loss were not major health problems. The average lifespan in the US was also shorter – and because we now live longer, many of us do so in noisier environments that increasingly impair our hearing.
Legislators have made strides in including hearing aids in Medicare coverage in recent years, but a House-approved bill in 2019 failed to pass in the Senate. Attempts to include the demand in the Democrats’ Build Back Better framework also failed.
Using hearing aids is not as easy as putting on reading glasses
The new class of over-the-counter hearing aids are designed to help adults with mild to moderate hearing loss. But for anyone who thinks getting an OTC hearing aid will help as easily as getting a pair of cheap reading glasses will improve their vision, Kelley warns it’s not that simple.
“That’s a good analogy,” she said, “except 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.”
That’s because many cases of hearing loss are highly individualized, with problems related to specific frequencies or environments.
“Hearing loss is unique to each person, and most don’t know whether their condition is mild, moderate, or greater, caused by another medical problem or something as simple as earwax,” Kate Carr, president of the Hearing Industries Association, said in a statement. by email. .
While many people may benefit from an OTC product, others may need to see a doctor and audiologist for more advanced care, Carr and others say.
The chance that some consumers will rely on trial-and-error to find a device that will work well for them led some commentators on the FDA proposal to ask the agency to ensure they can easily return OTC hearing aids. or exchange. The FDA declined to do so, citing existing consumer laws. But the last rule requires manufacturers to clearly state their return policies.
If you buy a hearing aid without a prescription, the Hearing Industries Association says you should keep your receipt and be aware of the device’s warranty and return information. It also warns consumers against using devices that over-amplify sound, as too high a volume can further damage their hearing.
The rule complies with a mandate established in 2017
Despite the cap on Medicare coverage, the OTC rule comes as a long-awaited victory, five years after Congress voted in 2017 to require the FDA to create an OTC category for hearing aids.
Regulators were urged to take action last summer when President Biden issued a comprehensive executive order to promote more competition. It instructed the Department of Health and Human Services to propose an OTC hearing aid rule, kicking off a new timeline.