USA – FDA issues proposed OTC hearing aid rule

The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.

Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017. The act directed FDA to create a report available for public comment by the end of 2020 on creating a new regulatory class for OTC hearing aids, but the process was delayed due to the COVID-19 pandemic. On 9 July, President Biden requested the Proposed rule be published within 120 days of issuing a wide-ranging Executive Order on promoting competition in the US economy…