Hearing aids: FDA completes rule to use on cheaper devices

People with mild to moderate hearing loss will be able to purchase hearing aids directly from a store or online, instead of getting a prescription, going to a hearing care professional, and having a custom practice.

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

In the US, 1 in 8 people aged 12 years and older has 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 rises to 50% by age 75.

But Only 16% of tens of millions of people with hearing loss hearing aid.

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

“Today’s action will not only help adults who perceive mild to moderate hearing loss access more affordable and innovative manufacturing options, but we also expect American industry to unleash the power to develop technology in ways that will impact future generations of the massive disability burden from hearing loss affecting the world.” said.

The long journey of the rule

Congress passed legislation to create an OTC hearing aid category with broad bilateral support and President Trump He signed the law in 2017.

However, no action was taken and Sen. Elizabeth Warren, one of the bill’s sponsors, gave the FDA until August 2020 to publish the regulations. He and his co-sponsor Sen. Chuck Grassley sent north literature He urged the FDA to take action.

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President Biden in July 2021 signed an admin order created in part to speed things up.

The FDA initially said the pandemic delayed the rule’s implementation. The agency said on Tuesday that there are many public comments that need to be reviewed.

During the public health review period, some hearing health associations concerns raised About the proposed changes, he suggests that the devices will 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 that will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, vice president of the group’s Board of Audiology practice. Directors. “It’s important for the public to understand that these devices are only for adults with mild to moderate hearing loss and consider having a hearing evaluation by a certified audiologist as a first step before purchasing anything.”

An expensive medical device

The rule does not change the way hearing aids are covered. While private insurers pay for treatment after a limb loss or even cover the cost of Viagra, most do not cover hearing aids. Basis health care it doesn’t pay for them either, and only half of government Medicaid programs do.

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Hearing aids are not cheap. According to a study published in 2020, people spend, on average, at least $4,000 for devices for both ears. hole. Prices may vary: Major retailers can offer a pair can cost around $1,400, but some $6,000 a yeardepending on technology.

Five big companies now 90% control Such consolidation of the global market for hearing aids has meant that there is little price competition, and high prices may be a big 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 lower-cost benchtop devices in addition to their current offerings.

“Reducing healthcare costs in America has been my priority since Day One, and this rule is expected to help us provide access to quality, affordable healthcare for the millions of Americans who need it,” Health and Human Services Secretary Xavier Becerra said in a statement. Said. Tuesday.

How will the new rule work?

Currently, people can only get hearing aids with an expensive medical examination or prescription from a professional to fit the device. Audiologists can adjust for life if someone’s hearing worsens.

With a countertop device, buyers can set them up by themselves.

this new rule The FDA said it only applies to certain types of hearing aids. People with severe hearing loss and under the age of 18 will still need a prescription.

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Under the new rule, over-the-counter hearing aids, like any other medical device, will need to meet the FDA’s high standards of safety, labeling and manufacturing protection to be allowed on the market.

“I think today is an extraordinary day,” Becerra said. “Americans who need help with their hearing aids – this includes my mom – help is on the way. So over-the-counter hearing aids – get ready guys, you’ll save a lot of money and we’ll all benefit from it.”

Why are hearing aids important?

Hearing aids are not just nice to have for people to hear; they are also necessary for physical and mental health.

People with hearing loss without hearing aids are more likely to complain unhealthy in general and less likely to leave home or exercise, studies found.

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there is a link between hearing loss general fragility and increasing falling risksecond leading cause of unintentional death worldwide World Health Association.

Various studies have also found a link between hearing loss and hearing loss. poorer mental health and psychosocial health.

Hearing loss can cause this depressionloneliness and insulationand even dementia.

With hearing aids becoming easier to access, “I have 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 is little innovation in this area because of the way the market is organized.

“In 1977, due to the technology at the time, the only way hearing aids could be safe and effective was if they were programmed, fitted and professionally adjusted by a licensed provider,” Lin said. Said. Fast forward 45 years later, these rules are still on the books, but the market and this technology have changed dramatically.

“This will allow companies that make innovative headphones like Samsung, Apple, Google 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 a similar price.

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

“It was a real bipartisanship. That’s how the government should work,” Lin said. “This really, really reassures me state.”