April 6, 2022
Representatives Betty McCollum and Rosa DeLauro sent a letter to FDA Commissioner Robert Califf to revisit the importance of amending certain provisions in the Proposed Rule for over-the-counter (OTC) hearing aids. There is an overwhelming consensus that the currently proposed output and gain limits for OTC hearing devices pose consumer and patient safety risks, such as worsening existing symptoms and delaying proper treatment. To rectify these concerns, legislators are rightfully reaching out and asking the FDA to #ListenCarefully to public feedback.
See or download full letter here.