In a letter sent out today by Brandon Sawalich, President and CEO of Starkey, it was announced that the Office of Management and Budget (OMB) concluded their review of the draft over-the-counter (OTC) hearing aid rule. The rule will now go back to the Food and Drug Administration (FDA) for final sign-off and approval. According to the letter, “we can expect the FDA to publicly promulgate the proposed rule in the short term, perhaps as soon as within two weeks”, and likely no later than November 6.
Once the rule is published in the Federal Register, the public will have 60 days to submit comments. So, the FDA regulations on OTC products could be in effect as early as February of 2022. This would be the culmination of process begun by the FDA Reauthorization Act of 2017 which outlined requirements to establish a category of OTC hearing aids and the requirements that apply to them – a process that was significantly delayed by the pandemic.