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Illinois Attorney General Kwame Raoul
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January 18, 2022

ATTORNEY GENERAL RAOUL URGES FDA TO PRESERVE STATE REGULATION OF OVER-THE-COUNTER HEARING AIDS

Chicago  — Attorney General Kwame Raoul, as part of a bipartisan coalition of 42 states and territories, today urged the U.S. Food and Drug Administration (FDA) to preserve states’ authority to enforce their consumer protection laws related to the sale of over-the-counter hearing aids.

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

“States already have regulations in place to support residents’ access to safe and affordable hearing aids,” Raoul said. “People who have mild or moderate hearing loss should be able to purchase hearing aids over the counter, and I encourage the FDA to ensure that any action it takes also preserves states’ abilities to continue to protect our residents.”

Currently, all 50 states have in place hearing professional licensing requirements, and many have important protections for hearing aid consumers, including mandatory warranties and returns and advertising restrictions. In their letter, Raoul and the attorneys general caution that rules currently under review by the FDA may unintentionally hinder or repeal those important consumer protections, undermining states’ abilities to ensure safe and affordable access to hearing aids. The attorneys general urge the FDA to make explicit that its federal rule will not preempt these critical 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 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 comment letter states.

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

“Additionally, we are concerned with the inadequate age verification processes mandated and deficient labeling requirements. Without these proper guardrails to protect consumers’ health, OTC hearing aids could result in hearing loss or other consumer harm. The FDA should mandate age verification processes to protect those under 18 and ensure proper labeling to make clear that OTC hearing aids are only for those with mild to moderate hearing loss,” the attorneys general state.

Joining Attorney General Raoul in sending the comment letter are the attorneys general of Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, West Virginia, and Wisconsin.

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