“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services (HHS) Secretary Xavier Becerra. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
To start the process, the FDA issued a notice of proposed rulemaking. During that process, stakeholders can make comments on the proposal. As it would be a major change affecting both manufacturers and medical providers, it’s likely to draw a large number of comments.
“Many hearing aids can be expensive,” the FDA said in a press release. “The rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers.”
Under the FDA’s proposal, consumers would be able to purchase hearing aids in more traditional brick-and-mortar retail stores or online rather than doctors’ offices or specialty retail outlets. The FDA predicts prices would eventually fall, giving consumers both greater choice and lower prices. That would be a great relief to consumers like Phillip from Wheelersburg, Ohio, who pointed out just how expensive these products can be.
“These are the most expensive hearing aids I have ever priced,” Phillip wrote in a ConsumerAffairs review of Belltone. “After some discounts and a good sales pitch they came in at $7900.00 for a pair.”
Industry response
The American Academy of Audiology, which represents the medical practitioners who currently prescribe hearing aids, said the proposal has been in the works for some time. Both Republicans and Democrats supported a bill that became law in 2017 that directed the FDA to create a new category of hearing aids that could be sold over the counter.
“The Academy has established a subject matter expert (SME) workgroup to review the proposed rule and new guidance,” the group said in a statement. “The workgroup will prepare comments for board review, and the Academy will submit comments to the FDA on behalf of the organization.”
The FDA estimates that about 15% of adults in the U.S. have some difficulty hearing. But the agency says only about 20% of that group use a hearing aid.
The agency said it believes the rule change would reduce the “barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices or certain state and federal regulations.”
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