(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 C.F.R. § 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 C.F.R. § 800.30 (2022), intended for people 18 years of age and older who have perceived mild to moderate hearing loss.
Rulemaking Authority Florida Statutes § 468.1135(4), 468.1225(7) FS. Law Implemented 468.1225(7) FS. History—New 4-24-23.