ARTICLE SUMMARY:
FDA has received more than 900 comments on its OTC hearing aids draft regulation. Excerpted from Pathways' Picks January 19.
More than 900 public comments have come through to FDA in response to the agency’s October proposed rule to establish an over-the-counter (OCT) category for hearing aids. A notable portion of the comments were submitted by audiologists (who prescribe hearing aids), and other groups and individuals aligned with audiologists, lobbying FDA to put tighter limits on maximum volume output of hearing aids that can qualify for the OTC status and make other changes to significantly restrict the number of eligible devices. Established hearing aid manufacturers are similarly pressing FDA to retain stronger and more clearly defined premarket requirements for OTC hearing aids than what is proposed. And state attorneys general are worried that the new regulation will reassert federal preemptions over state compliance efforts, even for non-OTC hearing aids. Comments were due January 18, though more letters are likely to be posted publicly in the coming days as FDA processes the incoming feedback.
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