The president last year called on the FDA to make hearing aids available without a prescription in its executive order Promoting Competition in the American Economy to reduce costs and increase competition in certain industries.
The new regulations will create a new category of hearing aids that will replace state-level regulations that require patients to visit doctors or audiologists to get prescriptions and attachments. The devices will be available to individuals 18 years of age and older with mild to moderate hearing loss at pharmacies, retail stores and online.
sen. Elizabeth Warren (D-Mass.), a co-sponsor of the Over-the-Counter Hearing Aid Act, praised the decision on Twitter and praised Biden for moving the issue forward after it got bogged down with the FDA.
“It has taken years of hard work, but I’m happy that millions of Americans — many of whom don’t use hearing aids because they are too expensive — will soon be able to buy safe and affordable hearing aids without a prescription,” she says. tweeted. “This is what it looks like when government works for working people.”
The change is expected to significantly benefit older adults — individuals most likely to have hearing loss and on a steady income — as well as those in poor and rural communities with fewer audiologists.
The move comes more than four years after Congress ordered the FDA to draft regulations for over-the-counter devices.
Hearing aids without prescription or research? The FDA is taking a big step to make that possible.
“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. “Today’s action by the FDA is an important milestone in making hearing aids more cost-effective and accessible.”
The current price of hearing aids averages over $5,000 per pair, and they are usually not covered by traditional Medicare or other insurers. Vice President Harris said the rule would cut the cost of hearing aids by hundreds and even thousands of dollars.
“Every American has the right to affordable health care,” she said in a statement Tuesday. “Today, our government took another step forward in our fight to protect that right.”
A study published in Social Science and Medicine in 2019 found that the counties with the highest numbers of older adults with hearing loss tended to have fewer available audiologists, in part because the doctors tend to work in younger, wealthier urban areas.
Stigma, lack of access, and confusion about how to get the best health care often prevent people — especially older Americans — from taking care of their hearing health, said Barbara Kelley, executive director of the Hearing Loss Association of America. This option will benefit countless Americans who may need hearing aid at restaurants or large family gatherings without necessarily seeking out a hearing care professional, she said.
“We’ve spent years working on affordable and accessible hearing care, and this is a huge step in getting people to pay attention to their hearing health sooner or later,” Kelley said. “And this just opens up a new avenue — really a new avenue — for adults with mild to moderate hearing loss who can take a step on their own.”
Although about 38 million adults in the United States report hearing loss, few have tried the devices. Of those over 70 with hearing loss, only one in three have ever worn one, according to data collected in the National Health Interview Survey.
The FDA’s move follows years of federal efforts to remove barriers between patients and over-the-counter hearing aids. In 2015, the President’s Council of Advisors on Science and Technology under Barack Obama advised the FDA to create a new category of “basic” hearing aids that can be purchased without a prescription or without a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, giving the FDA three years to enact the new rules.
The FDA missed that 2020 deadline, but President Biden renewed the pressure in July 2021 when he signed an executive order setting a November deadline for a new proposed federal agency rule.