FDA Acknowledges Missing Deadline to Propose Rule on OTC Hearing Aids

The Food and Drug Administration acknowledged missing its statutory deadline under the FDA Reauthorization Act of 2017 for proposing the rule to create a category of over-the-counter hearing aids for people with mild or moderate hearing loss. Section 709 of the statute gave the FDA three years after enactment to release the proposed rule for public comment. The three-year deadline was Tuesday. "Although FDA staff are tirelessly working to meet the urgent needs of COVID-19 patients and health care providers during these unprecedented times, issuing the proposed rule remains a priority and we are working expeditiously to do so," emailed a spokesperson Thursday. The agency hopes to release the proposed rule in the fall, and "appropriate timing updates will be available at that time," she said. It will post the proposed rule in the Federal Register and open a docket for public comment, plus promote it through web updates and other "agency communications," she said. Section 709 is silent on how long the comment period should last, but requires the FDA to publish the final rule creating the OTC category no more than 180 days after comments close. CTA has a certification logo waiting to identify reputable OTC hearing aids meeting minimum voluntary performance criteria in the ANSI/CTA-2051 standard approved in January 2017 (see 2007180003). The logo is useless until the FDA creates the OTC category.