Yost asks FDA to protect state regulation of over-the-counter hearing aids

Published 12:00 am Saturday, January 22, 2022

COLUMBUS — A bipartisan coalition of 42 states and territories co-led by Ohio Attorney General Dave Yost today called on the U.S. Food and Drug Administration to preserve states’ authority to enforce their consumer protection laws in the sale of over-the-counter hearing aids.

The FDA is currently considering a proposal that would allow a new category of over-the-counter hearing aids to be sold directly to consumers without a medical exam or fitting by an audiologist.

“There need to be affordable options for Ohioans who need hearing assistance, but some of the ‘aids’ out there are nothing more than a decorative ear piece,” Yost said. “The states’ ability to protect consumers with things such as warranties, refunds and exchanges is vital and these new rules could prevent that.”

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Currently, all 50 states have licensing requirements for hearing professionals and many have important protections for hearing aid consumers, including mandatory warranties and returns and advertising restrictions. The attorneys general caution that rules currently under review by the FDA may unintentionally hinder or repeal these important consumer protections, undermining states’ abilities to ensure safe and affordable access to hearing aids.

In a letter sent to the FDA, the attorneys general urged the agency to explicitly clarify that any new federal rules won’t preempt such crucial state consumer protections.

“While the FDA’s proposed rule offers consumers much-needed relief in the form of more affordable and accessible hearing aids, it could have unintended negative consequences on our constituents,” the letter states. “The proposed rule includes broad language that could be interpreted to repeal virtually all the state-requested exemptions from preemption issued by the FDA since 1980 — even those related exclusively to non-OTC hearing aids. Such language could create unneeded confusion and the potential for unnecessary litigation.”

The attorneys general further urged the FDA to strengthen age-verification processes to protect those under 18 and make it clear that over-the-counter hearing aids are only appropriate for those with mild to moderate hearing loss.

“Without these proper guardrails to protect consumers’ health, OTC hearing aids could result in hearing loss or other consumer harm,” the letter states.