Hearing aids are becoming more affordable, but challenges remain: NPR

In this photo illustration, Janine Ramirez, a hearing aid specialist with Hear Again America, places a hearing aid on an ear on Oct. 20, 2021, in Fort Lauderdale, Florida.

Joe Raedle/Getty Images

hide caption

change caption

Joe Raedle/Getty Images

In this photo illustration, Janine Ramirez, a hearing aid specialist with Hear Again America, places a hearing aid on an ear on Oct. 20, 2021, in Fort Lauderdale, Florida.

Joe Raedle/Getty Images

Medicare does not cover hearing aids; nor are most insurance policies. That’s why advocates want a new federal rule allowing over-the-counter sales of the devices, hoping the move will cut 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 pharmacies that are far less expensive than prescription aids 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 this cost alone – and it’s just one of the challenges that still confront people with hearing loss.

“We are very 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 an overview of why the rule is celebrated, and what problems still exist.

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’s no such thing as a little hearing loss. It can be completely disruptive to your life.”

The new rule’s promise to minimize a range 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 falling, reduced mobility, depression, social isolation and anxiety,” Tucci said on his federal agency’s website.

Using hearing aids can make a big difference. As the Hearing Industries Association said in an email to NPR, “8 out of 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 on the order of $1,400 per individual hearing aid or over $2,800 per pair,” Brian Deese, director of the National Economic Council, said of the new FDA rule.

That’s a significant savings for an important item that the Hearing Industries Association says can range from under $1,000 up to $4,000 each.

The industry group notes that the actual devices typically make up only about a third of the total cost, since the process of getting a prescription hearing aid normally includes many visits to doctors and specialists who assess patients and fit, test and adjust their hearing aids.

OTC aids may compete with PSAP devices

By creating a new product category, the FDA is providing a regulated alternative to people who in recent years may have turned to PSAPs — or personal sound amplification products.

PSAPs are promoted as a way to augment a normal person’s hearing. But many who buy them are not hunters or private detectives – 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 must meet the FDA’s quality and labeling standards.

“The truth is, in that category, there are some very good devices that will transition to 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’s website states. “You pay 100% of the cost of hearing aids and exams.”

Many Americans may be surprised that the federal insurance program does not offer assistance to people most likely to need hearing aids. But that is by design.

“When the law was passed in 1965, hearing aids were not only not there, they were statutorily excluded,” Kelley said.

Other components of modern insurance, such as dental and vision coverage, were similarly left out of the original law — although in today’s system, some Medicare Advantage plans include coverage for those costs.

Kelley says several ideas are behind the exclusion, including a belief in 1965 that problems like hearing loss were not major health problems. Life expectancy in the US was also shorter – and as we now live longer, many of us do so in noisier environments that gradually damage our ability to hear.

Lawmakers have made progress in including hearing aids in Medicare coverage in recent years, but a bill approved by the House in 2019 failed to advance in the Senate. Efforts to include the requirement in the Democrats’ Build Back Better framework also foundered.

Wearing hearing aids is not as easy as putting on reading glasses

The new class of over-the-counter hearing aids is intended to help adults with mild to moderate hearing loss. But for anyone who thinks getting an OTC hearing aid will help them as easily as picking up a pair of cheap reading glasses improves their vision, Kelley warns it’s not that simple.

“It’s a good analogy,” she said, “except I want 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 linked to specific frequencies or environments.

“Hearing loss is unique to each person, and most people don’t know if their condition is mild, moderate or major, caused by another medical problem or something as simple as earwax,” Hearing Industries Association president Kate Carr said in an emailed statement. .

While many people may benefit from an OTC product, others may need to see a doctor and an audiologist for more sophisticated treatment, Carr and others say.

The possibility that some consumers may rely on trial and error to find a device that works well for them led some commenters on the FDA proposal to ask the agency to ensure that they can easily return or exchange OTC hearing aids. The FDA refused to do so, citing existing consumer laws. But the final rule requires manufacturers to clearly state their return policies.

If you buy a hearing aid without a prescription, the Hearing Industry Association says you should hang on to the receipt and be aware of the device’s warranty and return details. It also warns consumers against using devices that over-amplify sound, as too much volume can further damage their hearing.

The rule fulfills a mandate set in 2017

Despite the cap on Medicare coverage, the OTC rule comes as a much-anticipated victory, arriving five years after Congress voted in 2017 to require the FDA to create an OTC category for hearing aids.

Regulators were prompted to take action last summer, when President Biden issued a sweeping order to promote more competition. It tasked the Department of Health and Human Services with proposing an OTC hearing aid rule, setting a new timeline in motion.