(Reuters) – The U.S. Food and Drug Administration on Tuesday proposed creation of a new category of over-the-counter (OTC) hearing aids to be sold directly to millions of Americans in an effort to make the devices more affordable.
White House spokeswoman Jen Psaki said the proposed rules should be finalized next year and should increase competition to drive down prices, so the devices cost “hundreds instead of thousands of dollars.”
The changes “will help millions of Americans with mild to moderate healing loss get access to cheaper and more convenient access to hearing aids,” she told reporters, adding just one-fifth of the estimated 37.5 million Americans who have trouble hearing use such aids.
The rule allows greater reach to communities of color that have been typically lacked access to hearing aids, said Xavier Becerra, secretary of Health and Human Services.
Under the proposal, hearing aids for severe hearing loss or for users younger than 18 would remain as prescription devices.
The department will take comments on the proposed rule for 90 days and plan to implement the rule 60 days after finalizing it.
“Finalizing this remains a top priority for the agency,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press call.
Representative Debbie Dingell called the announcement “a major step forward for hearing health and will increase the accessibility of affordable hearing aid options for those who need them.”
The proposed rule follows an instruction in President Joe Biden’s broad competition executive order, which had told the Department of Health and Human Services to “promote the wide availability of low-cost hearing aids,” among many other instructions aimed at a wide variety of industries.
(Reporting by Manojna Maddipatla in Bengaluru and Diane Bartz and Trevor Hunnicutt in Washington; Editing by Shinjini Ganguli and Nick Zieminski)