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Hearing Aids: FDA finalizes rule designed to kickstart cheaper devices

Hearing Aids: FDA finalizes rule designed to kickstart cheaper devices
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Rather than getting a prescription, visiting a hearing care professional, and having a custom fitting made, 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. said Robert Califf.

About 1 in 8 people ages 12 and older in the US has hearing loss in both ears, and the rate increases significantly with age. About a quarter of those aged 65 to 74 have a hearing loss, and by age 75 the figure is 50%.

leg only over 16% of the tens of millions of people with hearing loss use a hearing aid.

The new devices won’t be free, but the FDA estimates the new rule could mean savings of 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 with mild to moderate hearing loss access more affordable and innovative production options, but we expect it will unleash the power of American industry to improve technology in a way that impacts the… tremendous burden of disability from hearing loss affecting the world,” he said on Tuesday.

The long journey usually

Congress passed legislation creating a category of OTC hearing aids with broad bipartisan support and President Trump put it into effect in 2017.
But nothing was done, and Sen. Elizabeth Warren, a supporter of the bill, gave the FDA until August 2020 to enact the regulations. She and co-sponsor Sen. Chuck Grassley sent several letters Ask the FDA to take action.
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In July 2021 President Biden signed an executive order created in part to speed things up.

The FDA initially said the pandemic delayed implementation of the rule. The agency said Tuesday it also had a lot of public comments to work through.

During the public health comment period, some listening health associations concerns expressed about the proposed changes, suggesting devices would still require the help of a professional.

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

“ASHA fully supports the creation of this new category of over-the-counter hearing aids that 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 suitable for adults with a perceived mild to moderate hearing loss, and that they strongly consider a hearing evaluation by a certified audiologist as a first step before purchasing anything.”

An expensive medical product

The rule doesn’t change how hearing aids are covered. While private insurers will cover treatment for limb loss or even the cost of Viagra, most will not cover hearing aids. basic Medicare neither does it pay for it, and only about half of state Medicaid programs do.
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Hearing aids are not cheap. According to a 2020 study published in , on average, people spend at least $4,000 out of pocket on devices for both ears PIT. Prices may vary: Large retailers can offer A pair costs about $1,400, but some can cost just as much $6,000 per yeardepending on the technology.
Five big companies now control 90% of the global marketplace for hearing aids. That sort of consolidation meant there was little price competition, and high prices could be a big reason 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 also develop lower-cost over-the-counter devices in addition to their current offerings.

“Reducing the cost of healthcare in America has been one of my priorities since day one, and this rule is designed to help us achieve quality and affordable access to healthcare for millions of Americans in need,” said Secretary of Health Xavier Becerra and human services, in a statement Tuesday.

How the new rule will work

Currently, people can only get hearing aids with an expensive medical exam or a prescription from a professional who will custom fit the device. Audiologists can also adjust it throughout life as hearing deteriorates.

For an over-the-counter device, buyers may be able to customize them themselves.

That new rule only applies to certain types of hearing aids, the FDA said. Those with severe hearing loss and those under the age of 18 will still need a prescription.
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Like all other medical devices, over-the-counter hearing aids must meet the FDA’s high standards for safety, labeling and manufacturing protection to be approved for the market.

“I think today is an outstanding day,” said Becerra. “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’ll all benefit.”

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 did not have hearing aids are more likely to come forward bad health overall, and they are less likely to leave home or exercise Studies have found.
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There is a link between hearing loss and general frailty and an increasing one risk of fallswhich are the second leading cause of accidental deaths worldwide, according to World Health Association.
Several studies have also found a link between hearing loss and worse mental health and psychosocial health.
Hearing loss can result depressionloneliness and isolationand even dementia.

With hearing aids likely to become more accessible, “I’ve got a big smile on my face right now,” said 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 due to the way the market is regulated.

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

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

He believes companies that can sell earbuds for $200 could easily sell hearing aids for a similar price.

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

“It was real impartiality. That’s how the government should work,” Lin said. “It really, really gives my confidence back Government.”

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