Affordable over-the-counter hearing aids will bring relief to millions of Americans suffering from hearing loss by mid-October, under a landmark proposal just announced by the U.S. Food and Drug Administration.
The final rule announced Tuesday creates a category of hearing aids that could be sold directly to consumers, without either a medical exam or a fitting by an audiologist.
“The rule will allow consumers to have greater control over their hearing aid purchasing decisions at stores nationwide or online without a professional hearing test, fitting adjustment or a prescription,” FDA Commissioner Dr. Robert Califf said during a media briefing. “People with hearing impairments, especially older Americans, could see over-the-counter hearing aids available as early as mid-October.”
Until now, folks with hearing loss have typically had to fork out thousands of dollars for a device that could only be adjusted by a professional audiologist.
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That’s been a barrier that left close to 30 million U.S. adults without the hearing help they need.
While roughly 15% of Americans report some trouble with their hearing, the FDA estimates that only 1 in 5 people who could benefit from a hearing aid actually use one.
President Joe Biden praised the FDA’s announcement.
“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,” Biden said in a statement issued by the White House.
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The over-the-counter category established in the new rule applies to hearing aids intended for people 18 or older who have mild to moderate hearing impairment. Other types of hearing aids — including those for children or people with severe hearing problems – will remain prescription devices.
The FDA received more than 1,000 public comments on the proposed rule when it was first issued on Oct. 20, 2021.
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Late changes
The final rule incorporates several changes suggested in those comments, including:
