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.
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.
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.
The final rule incorporates several changes suggested in those comments, including: