On April 6, Reps. Betty McCollum (D-MN) and Rosa DeLauro (D-CT) penned a letter to Food and Drug Administration (FDA) Commissioner Robert Califf to revisit the output and gain levels within the agency's proposed rulemaking on over-the-counter (OTC) hearing aids.
The lawmakers expressed concerns that the proposed decibel limit of 120, as well as the lack of a gain limit, could lead to worsening their existing symptoms or create irreparable damage to their hearing. To avoid these concerns, the lawmakers support a gain limit of 25 dB and an overall output limit of 110 dB — consistent with the consensus recommendations from leading hearing care professionals.
"Proper safeguards must be in place to protect Americans suffering from hearing loss," the lawmakers wrote. "As you finalize the Proposed Rule, we urge you to remember the staggering number of individuals and organizations who have spoken out in the name of patient and consumer safety."