On April 21, 2016, The Food and Drug Administration (FDA) held the "FDA Public Workshop: Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids." The webcast for the workshop is now available.
The workshop was in response to a report by the President’s Council of Advisors on Science and Technology (PCAST), whose recommendations included that the FDA exempt hearing aids from the Quality System Regulations (QSRs). It discussed the current QSRs and GMPs for hearing aids and to consider an alternative model for quality verification.
HLAA Board Chair Margaret Wallhagen, Ph.D., gave a 10-minute presentation on HLAA's views for consumer education, access, and protection. HLAA Board Member Richard Einhorn was also one of the public speakers. Many representatives from the hearing health care field provided comments. HLAA Executive Director Barbara Kelley and Director of Public Policy Lise Hamlin were in attendance. This is the first time that the FDA has invited HLAA to speak about hearing aids and we look forward to continuing the dialogue.