This new rule provides definitions for “prescription hearing aid” and “over-the-counter hearing aid,” which are defined by federal rule in 21 CFR Section 800.30 (2022).  

Document Information

Comments Open:
2/20/2023
Summary:
s new rule provides definitions for “prescription hearing aid” and “over-the-counter hearing aid,” which are defined by federal rule in CFR Section 800.30 (2022).
Purpose:
This new rule provides definitions for “prescription hearing aid” and “over-the-counter hearing aid,” which are defined by federal rule in 21 CFR Section 800.30 (2022).
Rulemaking Authority:
468.1135(4), 468.1225(7) FS.
Law:
468.1225(7) FS.
Related Rules: (1)
64B20-8.0011. General Definitions