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'Help is on the horizon': FDA finalizes rule to usher in cheaper hearing aids

(CNN)Long-awaited rule change could make hearing aids cheaper and betterThe U.S. Food and Drug Administration announced on Tuesday.

People with mild to moderate hearing loss can buy hearing aids in-store or online instead of getting a prescription, visiting a hearing specialist, or getting a custom-fit. will be available for purchase.

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

If hearing loss were officially recognized as a disability by the government, it would be the largest class of disability in the nation. About 1 in 8 people have hearing loss in both ears, and the percentage increases significantly with age. About a quarter of people aged 65 to her 74 have hearing loss, and by age 75 he reaches 50%.

but only 16% of tens of millions people with hearing loss use hearing aids

new devices won't be free No, but the FDA estimates that the new rule will save about $2,800 per pair. And in October, over-the-counter hearing aids could hit the market, Califf said.

"Today's measures not only ensure that adults with mild to moderate hearing loss have access to more affordable and innovative production options, but also empower America's industry. We hope to unlock and improve technology that will impact the enormous burden of hearing loss disability affecting the world," he said on Tuesday. The long road of

Congress passed a bill creating a category of OTC hearing aids with broad bipartisan support,and President Trump signed it into 40}
However, no action was taken and the bill's sponsor, Senator Elizabeth Warren, ordered the FDA to issue a rule until August 2020. She and her co-sponsor, Senator Chuck Grassley, sent several letters urging the FDA to take action.
In July 2021, President Biden signed an executive order designed to accelerate.
During Public Health's comment period, some hearing health associationsraised concerns about the proposed changes,and noted that the device still needed professional help.

On Tuesday, the American Speech-Language Hearing Association applauded the FDA's action.

"ASHA fully supports the creation of this new category of commercial hearing aids that will increase the availability and affordability of hearing aids for many Americans," said Audiology Director. Vice President Janice R. Trent said. Group board practice. “It is important for the public to understand that these devices are only intended for adults with a perceived mild to moderate hearing loss, and as a first step before purchasing anything, it is important that they are certified. strongly consider having your hearing evaluated by an audiologist.”

Expensive medical equipment

This rule changes hearing aid coverage. Not a thing. Private insurance companies cover the cost of treatment after losing a limb and the cost of Viagra, but most do not cover hearing aids.Basic Medicare also covers those costs. and pays only about half of the state's Medicaid program.
Hearing aids are not cheap.On average, people spend at least $4,000 on binaural devices, according to a 2020 study published in JAMA. However, some technologies cost $68} $6,000 per ear.
Currently, five large companies control 90% of the global market for hearing aids. This kind of integration means there is little price competition, and high prices may be a big reason why most people who need hearing aids don't have one.

The change is expected to bring more companies into the market.

Experts believe that incumbent manufacturers will also develop lower-cost commercial devices in addition to their current offerings.

"Reducing healthcare costs in America has been a priority of mine since day one, and this rule will help millions of Americans in need get quality, affordable healthcare." It is hoped that it will help achieve access to health and social services," Health and Human Services Secretary Xavier Becerra said in a statement Tuesday.

How the new regulations work

Currently, obtaining hearing aids requires either a costly medical examination or a hearing aid specialist who specializes in personalized hearing aids. I have to get a prescription from home. If someone's hearing deteriorates, an audiologist can also adjust it for life.

The new regulation applies only to certain types of hearing aids, he said, the FDA. People with severe hearing loss and her under 18 years old need a prescription.

Under new regulations, over-the-counter hearing aids, like all other medical devices, must meet the FDA's high standards for safety, labeling, and manufacturing protection.

"I think today is a wonderful day," said Becerra. "Americans in need of hearing aid help are asking for help, including my mom. Over-the-counter hearing aids are ready. Guys, you can save a lot of money, and we Everyone will benefit.”

Why Hearing Aids Matter

Hearing aids are more than just a convenience to have. They are also essential for physical and mental health.

People with hearing loss who do not own hearing aids are more likely to reportpoorer overall healthand are less likely to leave home or exercise.Research has shown.
There was an association between hearing loss and general frailty and increased risk of falling. is her second major cause. Unexpected deaths occur worldwide, according to the World Health Association.
Hearing loss and poorer mental health and psychosocial health have also been linked in several studies.
Hearing loss can lead to depression, loneliness and isolationand even dementia.

With hearing aids likely to be easier to access, "I have a big smile on my face now," says Frank Lin, director of the Cochlear Center for Hearing and Public Health. says Dr. He has been consulting with the government on the issue for eight years.

Lin said there has been little innovation in this area because the market is regulated.

"In 1977, with the technology of the time, the only way hearing aids were safe and effective was to be programmed, fitted and professionally adjusted by a licensed provider." It was," Lynn said. “After 45 years, these rules are still in the books, but the market and its technology have changed dramatically. I can. I really couldn't before.

He believes that if companies can sell earbuds for $200, they can easily sell hearing aids for similar prices.

because the new rules show governments can take action to improve health.

"This was truly bipartisan. ' said Lynn. "This has really restored confidence in the government."