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

Instead of getting a prescription, visiting a hearing health professional, and getting customized formulations, people with mild to moderate hearing loss will be able to purchase hearing aids directly in the store or online.

Food and Drug Administration Commissioner Dr. Robert Califf said the move would make hearing aids more widely available across the country.

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

But just around 16% of the tens of millions of people with hearing impairment use a hearing.

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

“Today’s action will not only help adults who have observed mild to moderate hearing loss gain access to more affordable innovative production options, but we expect it will unleash the power of American industry to improve technology in a way that will impact an enormous burden of disability from hearing loss affecting the world.” “.

Long Base Journey

Congress has passed legislation to create a class of over-the-counter hearing aids with broad bipartisan support, and President Trump She signed it into law in 2017.

But no action was taken, and Senator Elizabeth Warren, the bill’s sponsor, gave the Food and Drug Administration until August 2020 to issue the regulations. She and Senator Chuck Grassley sent several co-sponsors Letters Urging the Food and Drug Administration to take action.

In July 2021, President Biden Occurred An executive order created in part to speed things up.

The Food and Drug Administration initially said the pandemic had delayed implementation of the rule. On Tuesday, the agency said it also had a lot of public comment to go through.

During the public health suspension period, some auditory health associations Presented concerns About the proposed changes, indicating that the devices will still need professional help.

On Tuesday, the American Hearing, Speech-Language Association praised the Food and Drug Administration’s work.

“ASHA fully supports the creation 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 hearing practice on the group’s board of directors. directors. “It is important for the public to understand that these devices are only intended for adults with mild to moderate hearing loss, and to strongly consider getting a hearing evaluation by a certified audiologist as a first step before purchasing anything.”

Expensive medical device

The rule does not change how hearing aids are covered. While private insurance companies will pay for treatment after losing a limb or even cover the cost of Viagra, most do not cover hearing aids. Basic Medicare You don’t pay 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 their pocket on devices for both ears, according to a 2020 study published in gamma. Prices can vary: Major retailers may offer A pair for $1400, but some can cost up to $6000 per earaccording to technology.

Five big companies now control 90% of the global market for hearing aids. This kind of consolidation means there has been little price competition, and the higher prices may be a big reason why most people who need hearing aids don’t have them.

With this change, many companies are expected to enter the market.

Experts believe That existing manufacturers would also develop low-cost over-the-counter devices in addition to their existing offerings.

“Reducing health care costs in America has been a priority from day one, and this rule is expected to help us achieve access to affordable, quality health care for millions of Americans in need,” Secretary of Health and Human Services, Xavier Becerra, said in a statement. Tuesday.

How will the new rule work?

Currently, people can only obtain hearing aids with an expensive medical examination or a prescription from a specialist that matches the device for the individual. Audiologists can also adjust it over the course of their life if a person’s hearing worsens.

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

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

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To be allowed on the market, the new rule says, over-the-counter hearing devices will need to meet the US Food and Drug Administration’s high standards for safety, labeling and manufacturing protection like all other medical devices.

“I think today is a special day,” Becerra said. “Americans who need help with their hearing aids—my mom included—help is on the way. So over-the-counter hearing aids—get ready, folks, you save a lot of money, and we all benefit.”

Why are hearing aids important

Hearing aids aren’t just cute so people can hear; It is also essential for physical and mental health.

People who are hard of hearing and who do not have hearing aids are more likely to report poor health In general, they are less likely to leave the house or exercise, Studies found.

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There is a link between hearing loss and general weakness and growing risk of fallingwhich is the second leading cause of unintended deaths worldwide, according to World Health Assembly.

Several studies have also found a link between hearing loss and Weaker mental health and mental and social health.

Hearing loss can lead to depressionloneliness and IsolationAnd even dementia.

With hearing aids potentially becoming easier to access, “I have a big smile on my face now,” said Dr. Frank Lane, 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 because of the way the market is organized.

“In 1977, because of technology at the time, the only way for hearing aids to be safe and effective was if they were professionally programmed, installed, and modified by a licensed provider,” Lynn said. “45 years later, those rules are still on the books, but the market and that technology has changed dramatically.

“This will allow companies like Samsung, Apple, Google and companies that make innovative earbuds, they can now enter the market. They couldn’t before.”

He believes that if companies could sell the earbuds for $200, they could easily sell the hearing aids for a similar price.

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

“This was a true bipartisanship,” Lin said. “This is how government should operate.” “This really, really restores my faith in him Government.”