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.
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
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.
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
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 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.
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.
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.”