The president asked the FDA to make hearing aids available without a prescription last year in his executive order Promoting Competition in the American Economy to lower costs and increase competition in certain industries.
The new regulations will create a new category of hearing aids that replace state-level regulations that require patients to visit doctors. or audiologists for prescriptions and adjustments. The devices will be available to people 18 and older with mild to moderate hearing loss at pharmacies, stores and online.
Sen. Elizabeth Warren (D-Mass.), a co-sponsor of the Over-the-Counter Hearing Aid Act, praised the decision on Twitter, crediting Biden for moving the issue forward after it stalled at the FDA.
“It took years of hard work, but I’m glad that millions of Americans, many of whom don’t wear hearing aids because they’re too expensive, will soon be able to buy safe and affordable hearing aids without a prescription,” he said. she tweeted. “This is what it looks like when the government works for the workers.”
The change is expected to significantly benefit older adults, people who are more likely to experience hearing loss and who are on a fixed income, as well as people in poor and rural communities who have fewer audiologists.
The move comes more than four years after Congress directed the FDA to develop regulations for over-the-counter devices.
“This rule is expected to help us achieve quality, affordable access to health care for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents an important milestone in making hearing aids more affordable and accessible.”
The Current Price of Hearing Aid Averages over $5,000 per pair, and are typically not covered by traditional Medicare or other insurers. Vice President Harris said the rule would cut the cost of hearing aids by hundreds or even thousands of dollars.
“Every American has the right to affordable health care,” he said in a statement Tuesday. “Today our administration has taken another step forward in our fight to protect that right.”
A study published in Social Science and Medicine in 2019 found that counties with the highest number of older adults with hearing loss often had fewer available audiologists, in part because doctors tend to practice in younger, wealthier urban areas.
Stigma, lack of access and confusion about how to get the best medical care often keep 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 might need hearing assistance at restaurants or large family gatherings without necessarily seeking out a hearing professional, she said.
“For years, we’ve worked to make hearing health care affordable and accessible, and this is a big step toward getting people to pay attention to their hearing health as soon as possible,” said Kelley. “And this just provides another pathway, truly a new pathway, 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. Among adults over 70 with hearing loss, only one in three have ever used one, according to data collected from the National Health Interview Survey.
The FDA 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 recommended that the FDA create a new category of “basic” hearing aids that could be purchased without a prescription or doctor’s visit. Two years later, President Donald Trump signed the Free Hearing Aid Act of 2017, giving the FDA three years to enact the new rules.
The FDA missed the 2020 deadline, but President Biden renewed the pressure in July 2021 when he signed an executive order that set a November deadline for a new rule proposed by the federal agency.