Editor’s Note: Attached is a July 2018 letter from the US FDA to hearing aid manufacturers which discusses the mandate for the agency to establish a new category of OTC hearing aids. The FDA letter notes that until the agency publishes final OTC hearing aid regulations “no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids….”
From: US FDA
Dear Hearing Aid Manufacturer:
In section 709 of the FDA Reauthorization Act of 2017 (FDARA), Congress enacted a definition, outlined certain requirements, and set forth a process for establishing a category of over-the-counter (OTC) hearing aids and the requirements that apply to them.
