Fla. Admin. Code Ann. R. 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.
Notes
Rulemaking Authority 468.1135(4), 468.1225(7) FS. Law Implemented 468.1225(7) FS.
New 4-24-23.
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