January 21, 2022

Attorneys General Bend FDA’s Ear on Proposed Rule for Over-the-Counter Hearing Aids

Lori Kalani, Bernard Nash

Cozen O'Connor

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Cozen O'Connor

The National Association of Attorneys General sent a comment letter to the FDA, signed by a bipartisan group of 42 AGs, urging it to ensure that states’ authority to protect consumers is not preempted in its proposed rule regarding the sale of over-the-counter hearing aids.
The letter notes that all 50 states currently require hearing professionals to be licensed and many states have specific consumer protections for individuals buying hearing aids, including mandatory disclosures, warranties, and returns; and further argues that the language of the proposed rule—while providing more affordable and accessible hearing aids—may unintentionally undermine states’ ability to protect consumers.
The letter asks the FDA to make explicit that its new rule will not preempt state consumer protections, as well as to strengthen age verification processes to protect minors and to clarify that OTC hearing aides are only appropriate for mild to moderate hearing loss.

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