Over-the-Counter (OTC) Hearing Aid Final Rule: Existing State Medical Clearance Requirements and “Prescription” Terminology

The Academy submitted a letter to the Federal Drug Administration (FDA) requesting clarification on two critical issues included in the final OTC rule to ensure the final rule can be implemented in an expeditious manner.

Many state audiology licensing laws currently include a requirement that an individual receive medical clearance or sign a document waiving that requirement prior to receiving a hearing aid. The final rule is clear that these state provisions may continue to exist but only with regard to “prescription hearing aids.” However, current state laws or regulations do not differentiate between the two “types” of hearing aids and instead reference only “hearing aids.” Until state licensing rules are updated to differentiate requirements for OTC hearing aids versus prescription hearing aids, it will be important for the FDA to provide guidance to states in terms of how these provisions should be applied.

The final rule classifies all non-OTC hearing aids as “prescription.” We are concerned that some interests may equate “prescription” hearing aids as requiring a “prescription” from an individual with prescriptive authority as that term is currently used. Prescriptive authority is currently defined at the state level for mid-level practitioners such as nurse practitioners and physician assistants—and may differ depending on the type of practitioner. Audiologists are not included in this classification. The Academy asks the FDA to weigh in on the distinction between “prescription” hearing aids and “prescriptive” authority.