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Do you hear that? It’s the sound of cheaper, FDA-approved over-the-counter hearing aids.
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On Tuesday, August 16, the United States Food & Drug Administration (FDA) released 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 require a medical examination, prescription or adjustment by an audiologist.
The devices will be aimed at people with perceived mild to moderate hearing loss and are expected to 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 in the economy. American.
“This action delivers on my commitment to lowering costs for American families, saving American families nearly $3,000 for a pair of hearing aids and giving people more choices to improve their health and well-being. -be,” the memoir reads.
The FDA rule took years to implement. As Newsweek reports, in 2017 Congress passed the Over-the-Counter Hearing Aids Act, which tasked the agency with authorizing the sale of over-the-counter hearing aids. In 2021, Biden issued an executive order on promoting competition in the US economy, calling for action and a 120-day deadline, which the FDA adhered to.
In an FDA press release, Commissioner Robert M. Califf said, “The establishment of this new regulatory category will allow people with mild to moderate hearing loss to have convenient access to a range of safe, effective and affordable hearing aids at their neighborhood store or online. .
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to communicate effectively in their daily social interactions,” Califf added.
Nearly 30 million adults could benefit from a hearing aid, according to the FDA, as only one-fifth of people with hearing problems currently use one due to consumer barriers including cost and coverage insurance.
Between the device and fitting services, hearing aids can cost more than $5,000 for the typical American, according to the Associated Press (AP). Medicare only pays for diagnostic tests, not hearing aids.
Addressing these hurdles, White House National Economic Council Director Brian Deese tweeted, “Requiring prescriptions to purchase hearing aids is an unnecessary burden and barrier to entry for new businesses, driving up the costs. Today we are fixing that. In October, people can buy many over-the-counter hearing aids, saving an average of $2,876/pair.
Although the FDA advised against quoting specific estimated costs when the rule is in place, it said customers should expect to see increased competition and a slew of new products and price ranges from manufacturers, according to the PA.
Other government officials were enthusiastic about the decision, such as Health and Human Services Secretary Xavier Becerra, who said on a media call after the FDA rule was announced: “Hearing aids in over-the-counter, get ready, you’re going to save a lot of money and we’re all going to benefit,” according to Newsweek.
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The over-the-counter hearing aid rule comes into effect in mid-October, which is when consumers will start to see hearing aids sold in stores and pharmacies. According to the FDA, prescriptions will still be needed for people with severe hearing loss and those under 18.