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over-the-counter hearing aid

Defined in 1 place of the United States Code.

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.

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