Hearing aids should get cheaper and possibly even better due to a long-awaited rule change that the US Food and Drug Administration announced Tuesday.
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.
If hearing loss were officially considered a disability by the government, it would be the largest disability class in the country.
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
Congress passed legislation to create a category of OTC hearing aids with wide bipartisan support, and President Trump signed it into law in 2017.
But no action was taken, and Sen. Elizabeth Warren, a sponsor of the bill, gave the FDA until August 2020 to issue the regulations. She and co-sponsor Sen. Chuck Grassley sent several letters urging the FDA to take action.
In July 2021, President Biden signed an executive order created in part to speed things along.
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.
During the public health comment period, some hearing health associations submitted concerns about the proposed changes, suggesting that devices would still require the help of a professional.
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
The rule doesn’t change how hearing aids are covered. While private insurers pay for treatment after the loss of a limb or even cover the cost of Viagra, most do not cover hearing aids. Basic Medicare doesn’t pay for them either, and only about half of state Medicaid programs do.
Hearing aids aren’t cheap. On average, people spend at least $4,000 out of pocket for devices for both ears, according to a 2020 study published in JAMA. Prices can vary: Large retailers may offer a pair for about $1,400, but some can cost as much as $6,000 per ear, depending on the technology.
Five large companies now control 90% of the global marketplace for hearing aids. That kind of consolidation meant there was little price competition, and high prices may be a big reason why most people who need hearing aids don’t have them.
With the change, many more companies are expected to enter the market.