FDA Finalizes Rule to Allow Over-the-Counter Hearing Aids
The FDA finalized new rules on Tuesday that will allow people over the age of 18 with mild to moderate hearing loss to purchase hearing aids without a prescription.
The FDA was directed to allow some over-the-counter hearing aids by the Over-the-Counter Hearing Aid Act of 2017, which was introduced by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) and signed into law by former President Donald Trump. However, it took the agency years to work out the details of the new rules, including how they would interact with state laws. A 2021 executive order by President Joe Biden called on the FDA to set a 120-day deadline for proposing new rules, which the agency met.
Over-the-counter hearing aids are expected to arrive online and in stores by mid-October, 60 days after the new rules are registered. An FDA news release said the regulations were designed to assure customers of “safety and effectiveness” while “fostering innovation and competition.”
Coverage was mostly balanced across the spectrum. Many articles highlighted consumers’ potential savings on hearing aids, which can cost thousands of dollars per pair and are often not covered by insurance. Coverage in The Verge (Lean Left bias) stood out by highlighting concerns from audiologists and saying tech companies would “commoditize” the hearing aid industry.
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From the LeftFDA moves to allow hearing aids sold without a prescription
The Food and Drug Administration said Tuesday it is allowing hearing aids to be made available over the counter without the need for costly medical exams or prescriptions.
The FDA’s move establishes a new category of over-the-counter hearing aids that can be sold directly to consumers. It only applies to hearing devices for adults with mild to moderate hearing problems, excluding devices for more severe hearing loss, which will still require a prescription.
The action is intended to make hearing aids cheaper and more widely available to tens of millions of people...
From the CenterFDA Clears Hearing Aids for Over-the-Counter Sale
The Food and Drug Administration said it would allow some hearing aids to be sold over the counter, aiming to widen their availability in ways that could bring down costs and encourage development of better devices.
Some 30 million adults in the U.S. have trouble with their hearing, the FDA said, but only about 20% use a hearing aid. High costs, challenges with access and social stigma discourage some people from using the devices, the FDA said. The devices can cost thousands of dollars and often aren’t covered by insurance.
From the RightFDA to allow select hearing aids to be sold over the counter
Hearing aids will soon be available for purchase over the counter at a local pharmacy or drugstore.
The Food and Drug Administration finalized a ruling that will allow select hearing aids to be sold at stores or online retailers without a prescription or a medical exam at a lower cost.
"For many Americans who suffer from hearing loss, safe and effective and high quality hearing aids have been unaffordable. Hearing aids can cost thousands of dollars per pair and they're not always covered by insurance," said HHS Secretary Xavier Becerra. "Americans who need help with their...