over-the-counter hearing aid
(1) Definition (A) In general In this subsection, the term “over-the-counter hearing aid” means a device that— (i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations ) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations ) (or any successor regulation); (ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment; (iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs; (iv) may— (I) use wireless technology; or (II) include tests for self-assessment of hearing loss; and (v) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online. (B) Exception Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.