The move was celebrated by the Biden administration as an agenda win, as the president had run on a platform of expanding access to high-quality health care and lowering costs for the American public.
“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” Joe Biden said in a statement released by the White House on Tuesday.
“When too few companies dominate, American consumers pay higher costs. We’re finally building an economy that works for working families,” he added, noting how the new rule helps deliver on another one of his administration’s goals to take action on diversifying the economy to drive prices down on highly sought-after medical devices and treatments.
James Kennedy, a New York-based theatre professional, celebrated the news as life-changing.
my last pair of hearing aids cost over $4k out of pocket. i haven’t been able to get one fixed because they’re six years old and the technology is obsolete, but i can’t yet afford new ones, so i’m relying on an even older pair. this decision will literally change my life. wow. https://t.co/aIP6Azr5nC
— james (on hiatus) (@jamesholod) August 16, 2022
The action will create a new category of over-the-counter (OTC) hearing aids, which will be available for persons experiencing mild to moderate hearing impairment to purchase the devices from physical stores or through online suppliers without the prerequisite of a medical exam or a prescription, the federal agency said in a press release.
Driving down the price of hearing aids, which the FDA estimates are used by nearly 30 million Americans, would be a significant achievement for the Biden administration. Between the device itself and fitting services, it can sometimes cost Americans more than $5,000.
The retail price isn’t the only hurdle for consumers, as insurance coverage for the devices remains rather limited and Medicare - the US government national health insurance program - only covers tests for the devices, not the hearing aids themselves.
For millions, hearing aids and the doctor’s visit to get them are too expensive. That's why I called on the FDA to make them available over the counter.
Today, they did just that. This action will increase competition and lower the price of a pair by nearly $3,000.
— President Biden (@POTUS) August 16, 2022
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in the statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
Today, we took action to establish a new category of over-the-counter hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers. https://t.co/xAuSXWYeal pic.twitter.com/6hUYatBKY8
— U.S. FDA (@US_FDA) August 16, 2022
The finalisation of the rule to get access to over-the-counter hearing aids in America arrives after President Biden issued an executive order last year to promote competition in the economy, which included a 120-day deadline for the FDA to take steps to allow hearing aids to be sold over the counter.
It also arrives after a bipartisan piece of legislation passed in 2017, which also required the federal agency to create a specific category for the over-the-counter devices. However, that was only just implemented with the recent rule.
“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,” said FDA Commissioner Robert M Califf in the release.
For individuals who are affected by more severe hearing loss, however, this new rule will not apply to their devices as those will still require a prescription.