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

Instead of getting a prescription, seeing a hearing professional, and getting a custom fitting, people with mild to moderate hearing loss will be able to purchase hearing aids directly from a store or online.

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

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

But only about 16% of the tens of millions of people with hearing loss use a listening device for the hearing impaired.

The new devices won’t be free, but the FDA estimates the new rule could mean savings of around $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 production options, but we expect it will unleash the power of American industry to improve technology in a way that will impact the enormous burden of hearing loss disability that affects the world,” he said Tuesday.

The long journey of the ruler

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

The FDA initially said the pandemic delayed implementation of the rule. The agency said on Tuesday that it also has plenty of public comments to go through.

During the public health comment period, some hearing health associations concerns submitted on the proposed changes, suggesting that the devices would still require professional help.

On Tuesday, the American Speech-Language-Hearing Association hailed 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 the practice of audiology for the board of directors of the group. Directors. “It is important for the public to understand that these devices are only intended for adults with perceived mild to moderate hearing loss, and to seriously consider having hearing assessed by a board-certified audiologist as a first step before purchasing. anything.”

An expensive medical device

The rule does not change how hearing aids are covered. While private insurers pay for treatment after limb loss or even cover the cost of Viagra, most don’t cover hearing aids. Basic Health Insurance doesn’t pay for them either, and only about half of state Medicaid programs do.
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Hearing aids are not cheap. On average, people spend at least $4,000 out of pocket on devices for both ears, according to a 2020 study published in JAMA. Prices may vary: Major retailers can offer a pair for around $1,400, but some can cost up to $6,000 per eardepending on the technology.
Five big companies now control 90% of the global hearing aid market. This type of consolidation meant that there was little competition on price, and high prices may 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 also develop lower-cost 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 should help us gain access to affordable, quality health care for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra said in a statement. Tuesday.

How the new rule will work

Currently, people can only obtain hearing aids with an expensive medical examination or a prescription from a professional who will fit the device to the individual. Audiologists can also adjust it over its lifetime if someone’s hearing deteriorates.

With an over-the-counter device, buyers may be able to adjust them themselves.

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

“I think today is an exceptional 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 be able to save a lot of money. money. money, and we’re all going to enjoy 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 did not have hearing aids are more likely to report bad health overall, and they are less likely to leave the house or exercise, studies have found.
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There is a link between hearing loss and general fragility and an increase risk of fallingwhich are 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 cause the Depressionloneliness and insulationand even dementia.

With hearing aids likely to become 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 the government on this issue for eight years.

Lin said there has been little innovation in this space due to the way the market is regulated.

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

“It will allow companies like Samsung, Apple, Google, companies that already make innovative headphones, to be able to enter the market now. They really couldn’t before.”

He thinks if companies can sell headphones for $200, they could easily sell hearing aids for a similar price.

The new rule is good for patients, he said, because it shows the government can take action that improves health.

“It was real bipartisanship. That’s how the government should work,” Lin said. “It really, really gives me confidence in government.”

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