over-the-counter hearing aid
(A)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) (or any successor regulation) or wireless air conduction hearing aids (as defined in) (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)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.