The FDA has moved to provide hearing aids on the shelf

The president asked the FDA to put hearing aids on the table last year in a bid to promote competition in the U.S. economy to reduce costs and increase competition in certain industries.

The new regulations create a new category of hearing aids that replaces state-level regulations requiring patients to visit doctors. or audiologists to obtain prescriptions and accessories. The devices are available in pharmacies, stores and online for people 18 and older with mild to moderate hearing loss.

The change is expected to benefit older adults — who are at risk of hearing loss and have fixed incomes — as well as fewer audiologists in poor and rural communities.

The move comes more than four years after Congress directed the FDA to draft regulations for over-the-counter devices.

Hearing aids without a prescription or exam? The FDA will take major steps to do this.

Health and Human Services Secretary Xavier Becerra said, “This legislation is expected to help us get quality, affordable health care to millions of Americans who need help. Today’s FDA action represents a major milestone in making hearing aids more affordable and accessible.”

Average price of current hearing aids Over $5,000 per pair, and are typically not covered by traditional Medicare or other insurers. Vice President Harris said the rule would cut 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 administration has taken another step in our struggle to protect his rights.

In the year A 2019 study published in Social Science & Medicine found that counties with larger numbers of adults with hearing loss often have fewer audiologists, in part because the doctors practice in younger, more affluent urban areas.

Stigma, lack of access and confusion about how to get better health care often prevent people — especially older Americans — from taking care of their hearing health, said Barbara Kelly, executive director of the Hearing Loss Association of America. This option will benefit countless Americans who need hearing assistance, perhaps at restaurants or large family gatherings, without needing a hearing care professional, she said.

“We’ve worked to provide affordable and accessible hearing care for years, and this is a big step forward in helping people get their hearing care sooner,” Kelly said. “And this is another way — a new way, really — for adults with mild to moderate hearing loss to take action on their own.”

Although nearly 38 million adults in the United States report hearing loss, few have tried the devices. Among adults over 70 with hearing loss, only one in three say they have never worn one Data collected through the National Health Interview Survey.

The FDA’s action follows federal efforts to eliminate prescription and over-the-counter hearing aids. In the year In 2015, Barack Obama’s Council of Science and Technology Advisers to the President recommended that the FDA create new “basic” hearing aids that can be purchased without a prescription or 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 push in July 2021 when he signed an executive order that set a November deadline for a new rule from the federal agency.