Instead of getting a prescription, visiting a hearing care professional and getting a custom fit, people with mild to moderate hearing loss can buy hearing aids directly from a store or online.
This move will make hearing aids much more widely available across the country, said FDA Commissioner Dr. Robert Califf.
About 1 in 8 people in the US aged 12 years and older has hearing loss in both ears, and this percentage increases significantly with age. About a quarter of 65- to 74-year-olds have hearing loss, rising to 50% by age 75.
The new devices won’t be free, but the FDA estimates the new rule could save about $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 manufacturing options, but we expect it to unleash the power of US industry to advance technology in a way that will impact the massive burden of hearing loss disability that is affecting the world,” he said Tuesday.
The long journey of the rule
The FDA initially said the pandemic was delaying implementation of the rule. The agency said Tuesday it also had many public comments to wade through.
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 audiology practices on the group’s board of directors. Directors. “It’s 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 assessment done by a certified audiologist before purchasing anything as a first step.”
An expensive medical device
With the change, many more companies are expected to enter the market.
“Reducing health care costs in America has been a priority of mine since day one and this rule is expected to help us provide quality, affordable access to health care for millions of Americans in need,” said Secretary of Health and 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 examination or prescription from a professional who will customize the device for the individual. Audiologists can also adjust it throughout the life if a person’s hearing gets worse.
With an over-the-counter device, buyers may be able to customize it themselves.
To be allowed on the market, the new rule says, over-the-counter hearing aids must meet the FDA’s high standards of safety, labeling and manufacturing protection, just like any other medical device.
“I think today is a standout 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 save a lot of money, and we’re all going to benefit from 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.
With hearing aids likely to become easier to access, “I now have a big smile on my face,” says 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 has been little innovation in this area because of the way the market has been regulated.
“In 1977, because of the technology at the time, the only way for hearing aids to be safe and effective was if they were programmed, fitted and professionally tuned by a licensed supplier,” said Lin. “Fast-forward, 45 years later, those rules are still on the books, but the market and that technology has changed dramatically.
“This allows companies like Samsung, Apple, Google, companies that already make innovative earbuds, to enter the market. They really couldn’t before.”
He believes that if companies can sell earplugs for $200, they can easily sell hearing aids for a comparable price.
The new rule is a good thing for patients, he said, because it shows the government can take measures that improve health.
“This was a real duality. This is how government should work,” Lin said. “This really, really restores my confidence in government.”