FDA moves to make hearing aids available over-the-counter
To lower costs and encourage competition in certain industries, the president called on the FDA to make hearing aids available over-the-counter in last year’s Executive Order Promoting Competition in the U.S. Economy.
The new regulation creates a new category of hearing aids that supersedes state-level regulations requiring patients to see a doctor. Or an audiologist to get a prescription and fitting. The device is available for purchase in pharmacies, stores, and online for individuals over the age of 18 with mild to moderate hearing loss.
Senator Elizabeth Warren (D, Massachusetts), co-sponsor of the Commercial Hearing Aids Act, took to Twitter to praise the decision, lauding Biden for moving the issue forward after FDA stalling.
“It took years of hard work, but millions of Americans – many of whom don’t use hearing aids because they are too expensive – will soon be able to purchase safe, affordable hearing aids over the counter. I am happy to be like you,” she said. Tweeted. “This is what government looks like when it works for working people.”
The change is expected to greatly benefit not only seniors on a regular income who are most likely to experience hearing loss, but also those in poorer and rural areas where audiologists are scarce.
The move comes more than four years after Congress ordered the FDA to create regulations for over-the-counter devices.
“This rule is expected to help achieve access to quality, affordable health care for millions of Americans in need,” said Secretary of Health and Human Services Xavier Becerra. “Today’s FDA action is an important milestone in making hearing aids more cost-effective and accessible.”
Hearing aids currently cost an average of over $5,000 per pair and are typically not covered by traditional Medicare or other insurance companies. 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 administration takes another step in the fight to defend that right. stepped out.”
A 2019 study published in Social Science and Medicine found that the counties with the highest number of older adults with hearing loss often have fewer audiologists available.
Barbara Kelly, executive director of the American Association for the Hearing Loss, said stigma, lack of access, and confusion about how to get the best health care are preventing people, especially older Americans, from managing their hearing health. says there are many. This option would benefit countless Americans who need hearing aids, perhaps in restaurants or at large family gatherings, without necessarily seeking a hearing professional.
“For years, we have been committed to affordable and accessible hearing health care. said. “And this just offers another avenue, a truly new one, for adults with mild to moderate hearing loss who can take the step on their own.”
About 38 million adults in the US have hearing loss, but few have tried the device. According to data collected in the National Health Interview Survey, only 1 in 3 adults with hearing loss over the age of 70 have worn one.
The FDA’s move follows years of federal efforts to remove barriers between patients and commercially available hearing aids. In 2015, the President’s Advisory Committee on Science and Technology under Barack Obama recommended that the FDA create a new category of “basic” hearing aids that can be purchased without a prescription or doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aids Act of 2017, giving the FDA three years to make new regulations.
The FDA missed its 2020 deadline, but President Biden renewed pressure in July 2021 when he signed an executive order setting a November deadline for new proposed regulations from federal agencies. .
