Can you hear that? It’s the sound of less expensive, over-the-counter hearing aids being approved by the FDA.
On Tuesday, Aug. 16, the U.S. Food & Drug Administration (FDA) issued a final rule that establishes a new category of over-the-counter (OTC) hearing aids that can be purchased directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
The devices will be for individuals with perceived mild to moderate hearing impairment and should end up costing them thousands less.
The announcement was followed by a White House brief in which President Joe Biden praised the FDA and his administration for following through on his previously issued executive order calling for more competition and less concentration throughout the U.S. economy.
“This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing,” read the brief.
The FDA rule took years to implement. As Newsweek reports, back in 2017, Congress passed the Over-the-Counter Hearing Aid Act, which charged the agency to permit the sale of over-the-counter hearing aids. In 2021, Biden issued an executive order on Promoting Competition in the American Economy, calling for action and a 120-day deadline, which the FDA met.
In an FDA press release, Commissioner Robert M. Califf stated, “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.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” Califf added.
According to the FDA, nearly 30 million adults could benefit from a hearing aid as only one-fifth of people with hearing problems currently use one due to consumer roadblocks, including cost and insurance coverage.
Between the device and fitting services, hearing aids can run more than $5,000 to the typical American, per The Associated Press (AP). Medicare only pays for diagnostic tests, not for hearing aids.
Addressing these obstacles, White House director of the National Economic Council Brian Deese tweeted, “Requiring prescriptions to buy hearing aids is an unnecessary burden and a barrier to entry for new firms, driving up costs. Today, we’re fixing that. By Oct. people can buy many hearing aids OTC, saving an avg $2,876/pair.”
Although the FDA advised against citing specific estimated costs when the rule is in place, it did state that customers should expect to see increased competition and a host of new products and price ranges from manufacturers, per the AP.
Other government officials were enthusiastic about the ruling, like Health and Human Services Secretary Xavier Becerra, who said in a media call following the FDA rule announcement, “Over-the-counter hearing aids, get ready folks, you’re gonna get to save a lot of money and we’re all gonna benefit,” per Newsweek.
The OTC hearing aid rule takes effect in mid-October, so that is when consumers will start to see hearing aids sold in stores and pharmacies. Prescriptions will still be required for those with severe hearing impairments and those under 18 years of age, per the FDA.
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