The FDA issued a proposal that some hearing aids be available for over-the-counter (OTC) purchase without a medical exam or fitting by an audiologist.
In their proposed rule, the agency wrote: “FDA is proposing to establish a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids will be intended to address perceived mild to moderate hearing loss in people age 18 or older. Alongside the OTC category, we are proposing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the eventual OTC category. We believe the proposals set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.”
There are more than 37 million adults in the U.S. with some hearing problems, according to the FDA’s press release on the proposal. “However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one,” the agency wrote. “The proposed rule aims to address barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices, or certain state and federal regulations.”
Moreover, the agency noted that making hearing aids available over the counter could foster innovation and competition and, since they would be offered in retail stores and online, prices could be lower than they currently are.
This proposal is one of the provisions in the Over-the-Counter Hearing Aid Act, which was enacted in 2017 under the FDA Reauthorization Act.
“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” said Acting FDA Commissioner Janet Woodcock, MD, in the press release. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options. The new regulatory category will provide the public with greater control over their hearing aid purchasing decisions at stores nationwide or online without the need for a professional hearing exam, fitting adjustment or a prescription.”
However, the FDA did note that for those with severe hearing loss or individuals younger than age 18, prescription devices will be required.
“More than 30 million people suffer from some sort of hearing loss, and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” Vinay Rathi, a physician at Massachusetts Eye and Ear was quoted by the Washington Post as saying. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists.”
While physicians and consumers welcomed this news, the Washington Post noted that some people aren’t so happy about it— namely, “the manufacturers who dominate the existing market.”
“Brandon Sawalich, CEO of Starkey, one of the five major hearing aid manufacturers, said the company welcomes the FDA’s proposal but cautioned that over-the-counter hearing aids will not be a panacea for all hearing health issues. He said he worries that bad actors might sell subpar devices and dupe consumers seeking high-quality hearing aids,” the Washington Post reported.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 494
Topic ID: 398,494,282,494,730,255,925
