On October 20, 2021, the U.S. Department of Health and Human Services (HHS) published this proposed rule regarding medical devices; ear, nose, and throat devices; and establishing over-the-counter hearing aids. In the rule, the Food and Drug Administration (FDA) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids . . .
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