The U.S. Food and Drug Administration (FDA) this week proposed a rule to establish a new category of over-the-counter (OTC) hearing aids, an action that mirrors efforts by U.S. Rep. Buddy Carter (R-GA).
When finalized, the FDA rule would allow hearing aids within the new category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist, the agency said on Oct. 19, adding that the proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.
“This is a commonsense effort to make hearing aids more affordable for those who need them,” said Rep. Carter. “Opening competition sparks innovation and brings down costs to increase access to devices that can drastically improve the quality of life for many Americans.”
The FDA’s proposed rule comes four years after Rep. Carter’s bipartisan Over-the-Counter Hearing Aid Act of 2017, which he introduced with former U.S. Rep. Joseph Kennedy (D-MA), was signed into law by the president as part of a larger reauthorization of the FDA.
“While it should not have taken this long, I appreciate the FDA finally heading Congress’ call to open this market,” the congressman said.
The National Institute on Deafness and Other Communications Disorders reports that only 1 in 5 who need hearing aids use them, with many citing cost as a barrier.