Bipartisan coalition urges FDA to preserve state authority enforcement of consumer protection laws with over-the-counter hearing aids.
Attorney General Chris Carr has joined a bipartisan coalition in urging the U.S. Food and Drug Administration (FDA) to preserve state authority to enforce consumer protection laws in connection to the sale of over-the-counter hearing aids.
“Georgia’s consumer protection laws exist to ensure our citizens are kept safe,” said Carr. “We are proud of the long-standing record we have protecting Georgians and are concerned by any federal rule that undermines that role. The FDA should work with us, not around us, on significant matters that impact our state.”
The FDA is currently considering a proposal that would establish for the first time 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.
Currently, all 50 states have hearing professional licensing requirements and many have important protections for hearing aid consumers, including mandatory warrantees and returns and advertising restrictions. The attorneys general caution that rules currently under review by the FDA may unintentionally hinder or repeal those important consumer protection authorities, undermining the ability of the states to ensure safe and affordable access to hearing aids. The attorneys general urge the FDA to make explicit that their federal rule will not preempt these critical state consumer protections.
The attorneys general sent a comment letter to the FDA. In part, the letter states, “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 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 write in the letter.
In addition to Georgia, the following states and territories joined in signing the comment letter: Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Guam, Hawaii, Illinois, 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.
Link to the letter: