64B20-8.0011. General Definitions

64B20-8.0011 General Definitions (1) Prescription Hearing Aid means a hearing aid or amplifying sound device that is not an Over-the-Counter Hearing Aid (OTC) as defined in Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids, 21 CFR Section 800.30 (2022), which is specifically incorporated by reference herein (http://www.flrules.org/Gateway/reference.asp?No=Ref-15274). Hearing aids intended for people younger than 18 years of age are prescription hearing aids. (2) Over-the-Counter Hearing Aid (OTC) means certain air-conduction hearing aids regulated by the Food and Drug Administration (FDA), in accordance with 21 CFR Section 800.30 (2022), intended for people 18 years of age and older who have perceived mild to moderate hearing loss.