; (C) that, 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; (D) that may— (i) use wireless technology; or (ii) include tests for self-assessment of hearing loss; and (E) that 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. (2) Regulation An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 2(b) of the Over-the-Counter Hearing Aid Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations). . (b) Regulations To establish category (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ), not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (p) of section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j ) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations. (2) Requirements In promulgating the regulations under paragraph (1), the Secretary shall— (A) include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids; (B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids; (C) include requirements for appropriate labeling of the over-the-counter hearing aid, including how consumers may report adverse events, any conditions or contraindications, and any advisements to consult promptly with a licensed physician