The U.S. Food and Drug Administration (FDA) has issued a letter to hearing aid manufacturers warning them not to market hearing aids as over-the-counter devices and reminding them that such a category of product does not exist until the final OTC regulations are published. (http://bit.ly/2OCiMMm.) William Maisel, MD, MPH, stated in the letter that no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids until that time. "Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements," he wrote. Under section 709 of the FDA Reauthorization Act of 2017 (FDARA), the FDA have until Aug. 18, 2020 to consider public comments and publish the final regulations within 180 days after the close of the comment period.
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