Instead of getting a prescription, visiting a hearing health professional and having a custom fitting, people with mild to moderate hearing loss will be able to buy hearing aids directly from 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 US ages 12 and older has hearing loss in both ears, and the rate increases significantly with age. About a quarter of people 65 to 74 have hearing loss, and that goes up to 50% around age 75.
The new devices won’t be free, but the FDA estimates that the new rule could mean savings of about $2,800 a 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 gain access to more affordable an innovative production options, but we expect that it will unleash the power of American industry to improve the technology in a way that it will impact the enormous burden of disability from hearing loss affecting the world,” he said Tuesday.
The rule’s long journey
The FDA initially said the pandemic delayed the implementation of the rule. The agency said Tuesday that it also had a lot of 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 devices, which will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, vice president for audiology practice for the group’s Board of Directors. “It is important the public understands these devices are only for adults with perceived mild to moderate hearing loss, and to strongly consider getting a hearing assessment by a certified audiologist as a first step before they purchase 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 is expected to help us achieve quality, affordable health care access for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra said in a…
Read More: Hearing aids: FDA finalizes rule that should usher in cheaper devices