Biden announces rule allowing stores to sell hearing aids over the counter

Hearing aids will be sold over the counter starting on Monday, the result of an executive order from President Joe Biden.

“Starting this week, we’re making hearing aids available over the counter, so people don’t have to pay for expensive visits to specialists,” Biden wrote in a tweet. “The FDA estimates this is going to save patients as much as $3,000 per pair.”

Former President Donald Trump signed the FDA Reauthorization Act of 2017 into law on Aug. 18 of that year; it contained a section on the regulation of over-the-counter hearing aids that read in part: “The Secretary of Health and Human Services … not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids … and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.”

The law required the Department of Health and Human Services to create a federal rule authorizing over-the-counter sales before it could take effect. This did not occur during Trump’s tenure.

In July 2021, Biden signed an executive order that included instructions to HHS “to promote the wide availability of low-cost hearing aids, not later than 120 days after the date of this order, publish for notice and comment a proposed rule on over-the-counter hearing-aids, as called for by section 709 of the FDA Reauthorization Act of 2017.”.

Following Biden’s order, the Food and Drug Administration drafted the rule for public comment and eventually published it in the Federal Register as a final rule on Aug. 17 this year; it went into effect on Oct. 17.

A 2011 study published in the journal JAMA Internal Medicine estimated that 48 million people in the United States have some level of hearing loss. Prescription hearing aid devices can vary in price from $2,000 to $8,000 on top of the costs of medical visits to obtain a prescription. Insurance coverage for hearing aids varies from state to state.

Walmart, the largest retailer in America, said in a press release that it will begin offering an assortment of aids for $199 to $999 per pair. Some private insurance plans offered under Medicare Advantage will cover the costs of the over-the-counter hearing aids.

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” FDA Commissioner Robert M. Califf said in a statement on Aug. 17.

The Hearing Loss Association of America, a nonprofit organization that advocates on behalf of those with hearing impairments, praised the finalized rule, calling it “a win for millions of adults who have hearing loss and may have been waiting to get the help they need.”

Manufacturers of hearing aids also support the new rule. Kate Carr, president of the Hearing Industries Association, a lobbying group that represents the manufacturers, said in a release, “This is a significant step forward for the millions of Americans who suffer hearing loss yet are untreated.”

In addition to the hearing aid rule, Biden recently signed into law the Inflation Reduction Act, which lowered prescription drug prices and put a cap on expenses for Medicare recipients. The administration also made an adjustment to the Affordable Care Act in October that expanded the pool of people who can sign up for health insurance coverage.

On Sept. 28, Biden hosted an event at the White House to mark the 32nd anniversary of the American with Disabilities Act. He said that under his administration, the Department of Labor is “protecting the rights of workers with disabilities and fighting to end unjust sub-minimum wages” for those workers.

Published with permission of The American Independent Foundation.