Washington, D.C. — The National Association of Attorneys General (NAAG) is urging the U.S. Food and Drug Administration (FDA) to preserve states’ authority to enforce their consumer protection laws in connection to the sale of over-the-counter hearing aids.
The FDA is currently considering a proposal that, for the first time, 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.
Currently, all 50 states have hearing professional licensing requirements and many have important protections for hearing aid consumers, including advertising restrictions, as well as mandatory warrantees and returns. The bipartisan coalition of 43 attorneys general cautions that rules currently under review by the FDA may unintentionally hinder or repeal those important consumer protection authorities, undermining states’ ability to ensure safe and affordable access to hearing aids. The attorneys general urge the FDA to make explicit that the new 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.
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.
The comment letter was led by Connecticut Attorney General William Tong and Ohio Attorney General Dave Yost.
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** This release was updated on January 18, 2022 to reflect all attorney general offices who signed the letter.