State AGs to FDA: Don’t Shut Us Out of OTC Hearing Aid Rule

It would be “unacceptable” for states to “cede the responsibility for protecting consumers” who use over-the-counter hearing aids “to the companies supplying the product,” a bipartisan group of 40 state attorneys general wrote the Food and Drug Administration Friday in the agency’s rulemaking to create a category of affordable OTC hearing aids for U.S. adults with mild to moderate hearing loss. Comments in the rulemaking were due Tuesday in docket FDA-2021-N-0555 (see 2112060002). “We must be allowed to continue with our traditional consumer protection role and we strongly encourage the FDA to make that clear in the final OTC Rule,” said the AGs. The proposed rule also is “inadequate” in the precautions to be taken against sales of OTC hearing aids to minors and contains “deficient labeling requirements,” they said. “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.”