On December 5, Senators Warren and Grassley sent a letter to the Acting FDA Commissioner, Brett Giroir, MD, pointing out the fact that the FDA previously announced that over-the-counter (OTC) hearing aid rules would be a priority on their fall 2018 Unified Agenda and they would likely deliver the proposed rules well in advance of the August 2020 statutory deadline. Senators Warren and Grassley note that “it is now December 2019 and we have yet to see these regulations come to fruition.”
Citing the serious nature of hearing difficulties and the related conditions that frequently accompany them, the letter requests that the FDA provide an update on the status of the OTC hearing aid rules and regulations and when the FDA expects to finalize the OTC hearing aid rules no later than December 19, 2019.
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