Hearing aids: FDA finalizes rule that should usher in cheaper devices


Instead of getting a prescription, visiting a hearing care professional and getting a custom fit, people with mild to moderate hearing loss can buy hearing aids directly from a store or online.

This move will make hearing aids much more widely available across the country, said FDA Commissioner Dr. Robert Califf.

About 1 in 8 people in the US aged 12 years and older has hearing loss in both ears, and this percentage increases significantly with age. About a quarter of 65- to 74-year-olds have hearing loss, rising to 50% by age 75.

But only about 16% of the tens of millions of people with hearing loss use hearing aids.

The new devices won’t be free, but the FDA estimates the new rule could save about $2,800 per pair. And people could see over-the-counter hearing aids on the market as early as October, Califf said.

“Today’s action will not only help adults who have perceived mild to moderate hearing loss access more affordable and innovative manufacturing options, but we expect it to unleash the power of US industry to advance technology in a way that will impact the massive burden of hearing loss disability that is affecting the world,” he said Tuesday.

The long journey of the rule

Congress passed legislation to create a category of OTC hearing aids with broad bipartisan support, and President Trump signed it into law in 2017.
But no action was taken, and Senator Elizabeth Warren, a sponsor of the bill, gave the FDA until August 2020 to issue the regulations. She and co-sponsor Senator Chuck Grassley sent several letters urging the FDA to take action.
In July 2021, President Biden signed an executive order intended in part to speed things up.

The FDA initially said the pandemic was delaying implementation of the rule. The agency said Tuesday it also had many public comments to wade through.

During the public health comment period, some hearing health associations expressed concern about the proposed changes, suggesting that devices would still need the help of a professional.

On Tuesday, the American Speech-Language-Hearing Association praised the FDA’s action.

“ASHA fully supports the creation of this new category of over-the-counter hearing aids, which will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, vice president of audiology practices on the group’s board of directors. Directors. “It’s important for the public to understand that these devices are only intended for adults with mild to moderate hearing loss, and to strongly consider getting a hearing assessment done by a certified audiologist before purchasing anything as a first step.”

An expensive medical device

The rule does not change the coverage of hearing aids. While private insurers will pay for treatment after the loss of a limb or even cover the cost of Viagra, most hearing aids do not cover. Basic Medicare doesn’t pay them either, and only about half of the state’s Medicaid programs do.
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Hearing aids are not cheap. According to a 2020 study published in JAMA, people spend on average at least $4,000 out of pocket for devices for both ears. Prices can vary: Major retailers can offer a pair for around $1,400, but some can cost as much as $6,000 per ear, depending on the technology.
Five major companies now control 90% of the global hearing aid market. That kind of consolidation meant there was little price competition, and high prices could be a major reason why most people who need hearing aids don’t have them.

With the change, many more companies are expected to enter the market.

Experts believe that existing manufacturers will develop cheaper over-the-counter devices in addition to their current offerings.

“Reducing health care costs in America has been a priority of mine since day one and this rule is expected to help us provide quality, affordable access to health care for millions of Americans in need,” said Secretary of Health and Human Services. Xavier Becerra in a statement. Tuesday.

How the new rule will work

Currently, people can only get hearing aids with an expensive medical examination or prescription from a professional who will customize the device for the individual. Audiologists can also adjust it throughout the life if a person’s hearing gets worse.

With an over-the-counter device, buyers may be able to customize it themselves.

The new rule only applies to certain types of hearing aids, the FDA said. People with severe hearing loss and those under the age of 18 still need a prescription.
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To be allowed on the market, the new rule says, over-the-counter hearing aids must meet the FDA’s high standards of safety, labeling and manufacturing protection, just like any other medical device.

“I think today is a standout day,” Becerra said. “Americans who need help with their hearing aids — and that includes my mom — help is on the way. So over-the-counter hearing aids — get ready, folks, you’re going to save a lot of money, and we’re all going to benefit from it.” .”

Why hearing aids are important

Hearing aids aren’t just nice to have so people can hear; they are also essential for physical and mental health.

People with hearing loss who didn’t have hearing aids are more likely to report overall poor health, and they’re less likely to go out of the house or exercise, studies show.
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There is a link between hearing loss and general frailty and an increasing risk of falls, the second leading cause of unintentional deaths worldwide, according to the World Health Association.
Several studies have also found a link between hearing loss and poorer mental health and psychosocial health.
Hearing loss can lead to depression, loneliness and isolation, and even dementia.

With hearing aids likely to become easier to access, “I now have a big smile on my face,” says Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health. He has been consulting with the government on this issue for eight years.

Lin said there has been little innovation in this area because of the way the market has been regulated.

“In 1977, because of the technology at the time, the only way for hearing aids to be safe and effective was if they were programmed, fitted and professionally tuned by a licensed supplier,” said Lin. “Fast-forward, 45 years later, those rules are still on the books, but the market and that technology has changed dramatically.

“This allows companies like Samsung, Apple, Google, companies that already make innovative earbuds, to enter the market. They really couldn’t before.”

He believes that if companies can sell earplugs for $200, they can easily sell hearing aids for a comparable price.

The new rule is a good thing for patients, he said, because it shows the government can take measures that improve health.

“This was a real duality. This is how government should work,” Lin said. “This really, really restores my confidence in government.”

The Valley Voice
The Valley Voicehttp://thevalleyvoice.org
Christopher Brito is a social media producer and trending writer for The Valley Voice, with a focus on sports and stories related to race and culture.


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