The FDA finalizes the rule that allows some Americans to buy hearing aids over the counter

Instead of getting a prescription, visiting a hearing care professional, and having a personalized fit, people with mild to moderate hearing loss will be able to purchase hearing aids directly in a store or online.

This 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 12 years of age or older have hearing loss in both ears, and the rate increases significantly with age. About a quarter of people aged 65 to 74 suffer from hearing loss, up to 50% by the age of 75.

But only about 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 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 experienced mild to moderate hearing loss access more affordable and innovative manufacturing options, but we expect it will unleash the power of American industry to improve technology in a so that it will impact the huge burden of disability due to hearing loss affecting the world, ”he said Tuesday.

The long journey of the rule

Congress passed a law to create an OTC hearing aid category with broad bipartisan support, and President Trump made it into law in 2017.

But no action was taken, and Senator Elizabeth Warren, sponsor of the bill, granted the FDA until August 2020 to issue the regulations. She and Senator Chuck Grassley’s co-sponsor sent several letters urging the FDA to take action.
In July 2021, President Biden signed an executive order created in part to speed things up.

The FDA initially said the pandemic delayed the implementation of the rule. The agency said on Tuesday it also had plenty of public comments to look into.

During the public health commentary period, some hearer associations expressed concerns about the proposed changes, suggesting that the devices would still need professional help.

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 audiological practice for the board of directors of the Directors group. “It is important that the public understand that these devices are only for adults with mild to moderate perceived hearing loss and that they strongly consider having a hearing assessment 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 the loss of a limb or even cover the cost of Viagra, most don’t cover hearing aids. Basic Medicare doesn’t pay them either, and only about half of state Medicaid programs do.
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Hearing aids aren’t cheap. On average, people spend at least $ 4,000 out of their own pocket on devices for both ears, according to a 2020 study published in JAMA. Prices can vary – large retailers can offer a pair for around $ 1,400, but some can cost up to $ 6,000 per ear, depending on the technology.
Five large companies now control 90% of the global hearing aid market. This type of consolidation meant there was little price competition, and high prices could 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 also develop low-cost benchtop devices in addition to their current offerings.

“Reducing the costs of health care in America has been a priority of mine since day one and this rule should help us gain access to quality and affordable health care for millions of Americans in need,” said the Secretary of Health and to 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 exam or a prescription from a professional who will tailor the device to the individual. Audiologists can also adjust it over the course of his life if someone’s hearing gets worse.

With a counter device, shoppers might be able to adjust them on their own.

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 will still need a prescription.
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To be admitted to the market under the new standard, over-the-counter hearing aids will need to meet the FDA’s high standards for safety, labeling and manufacturing protection like all other medical devices.

“I think today is an extraordinary 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’ll save a lot of money, and we’ll all benefit from it.”

Why hearing aids matter

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

Studies have found that people with hearing loss who did not have hearing aids are more likely to report poor health and less likely to leave the house or exercise.
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There is a link between hearing loss and general frailty and an increasing risk of falls, which are the second leading cause of involuntary deaths worldwide, according to the World Health Association.
Several studies have also found a link between hearing loss and deteriorating mental health and psychosocial health.
Hearing loss can lead to depression, loneliness and isolation, and 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 consulted with 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 time, the only way hearing aids were safe and effective was if they were professionally programmed, fitted and adjusted by an authorized supplier,” Lin said. “Fast forward 45 years later, those rules are still in the books, but the market and that technology have changed dramatically.

“This will allow companies like Samsung, Apple, Google, companies that are already making innovative headsets, to be able to enter the market now. Before, they really couldn’t.”

He believes that if companies can sell earphones 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 to improve health.

“This was true bipartisanism. This is the way the government is supposed to work,” Lin said. “This really, really restores my confidence government.”


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