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Hearing aids: FDA finalizes rules that should introduce cheaper devices

Hearing aids: FDA finalizes rules that should introduce cheaper devices
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Instead of getting a prescription, seeing a hearing health professional and getting a custom fitting, people with mild to moderate hearing loss will be able to buy hearing aids directly from a store or online.

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

About 1 in 8 people age 12 and older in the United States have hearing loss in both ears, and this rate increases significantly with age. About a quarter of people aged 65 to 74 have hearing loss, and this goes up to 50% around age 75.

but only about 16% of the millions of people with hearing loss use one help to listen.

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

“Today’s action will not only help adults with mild-to-moderate hearing loss gain access to innovative options at a more affordable cost, but we hope that it will enhance the strength of American industry in ways that will impact technology advancements. Hearing loss is a huge burden of disability.” affecting the world,” he said on Tuesday.

The long journey of rules

Congress passed legislation to create a category of OTC hearing aids with broad bipartisan support, and President Trump It was signed into law in 2017.
But no action was taken and sen. Bill sponsor Elizabeth Warren gave the FDA until August 2020 to issue the rule. He and co-sponsor Sen. Chuck Grassley sent several letters FDA is urged to take action.
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In July 2021, President Biden signed An executive order made in part to speed things up.

The FDA initially said the pandemic delayed implementation of the rule. The agency said Tuesday that it received a lot of public comment.

During the public health comment period, some hearing health associations Accumulated anxiety Regarding the proposed changes, advises that the devices will still need the help of a professional

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

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

An expensive medical device

The rule does not change how hearing aids are covered. While private insurers pay for treatment after losing a limb or even cover the cost of Viagra, most do not cover hearing aids. the basic Medicare Neither do they pay for it, and about half do state Medicaid programs.
A teacher designed shiny hearing aids on puppets to make her deaf students feel represented
Hearing aids are not cheap. According to a study published in 2020, people spend an average of at least $4,000 on devices for both ears. clothes. Prices may vary: Major retailers may offer A pair for around $1,400, but some can cost as much $6,000 per earDepends on the technology.
Five major companies now control 90% Global market for hearing aids. Such consolidation meant that there was little price competition, and high prices could be a big reason why most people who need hearing aids do not have them.

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

Experts believe Existing manufacturers will develop low-cost over-the-counter devices in addition to their current offerings.

“Reducing the cost of health care in America has been a priority of mine since day one, and this rule is expected to help millions of Americans get access to quality, affordable health care,” Health and Human Services Secretary Javier Becerra said in a statement. tuesday

How the new rules will work

Currently, people can only get hearing aids through an expensive medical exam or a prescription from a professional who will fit the device for the person. Audiologists can adjust someone’s hearing loss over their lifetime.

With an over-the-counter device, consumers may be able to adjust these on their own

The new rules Applies only to certain types of hearing aids, the FDA said. Those with severe hearing loss and those under 18 will 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 for safety, labeling and manufacturing safety, just like all other medical devices.

“I think today was a standout day,” Becerra said. “Americans who need help with their hearing aids — and that includes my mom — help is coming. 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.”

Why are hearing aids important?

Hearing aids aren’t just good so people can hear; They are also essential for physical and mental health.

People with hearing loss are more likely to report hearing loss than those without hearing aids bad health Overall, and they are less likely to leave the house or exercise, Research has found.
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There is a link Hearing loss and between General fragility and growing risk of fallingIt is the second leading cause of unintentional death worldwide World Health Organization.
Several studies have found a link between hearing loss and Poor mental health and psychosocial health.
May cause hearing loss depressionLoneliness and differentand even dementia.

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

Lin said there has been little innovation in this space because the market is regulated.

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

“It will allow companies like Samsung, Apple, Google, companies that are already making innovative earbuds, to enter the market now. They really couldn’t before.”

He believes that if companies can sell earbuds for $200, they can easily sell hearing aids for the same price.

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

“It was a true bipartisanship. That’s how government should work,” Lin said. “It really, really restored my faith government.”

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