,,ii #aaeth ,,congress #ast ,session ,s4 #fgj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ba1 #bjag,ms4 ,warren 7for herself1 ,mr4 ,grassley1 ,ms4 ,hassan1 and ,mr4 ,isakson7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for the regulation of over-the-counter hearing aids4 #a4 ,short title ,this ,act may be cited as the ,over-the-,counter ,hearing ,aid ,act of #bjag4 #b4 ,regulation of over-the-counter hearing aids 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7p7 ,regulation of ,over-the-,counter hearing aids 7#a7 ,definition ,in this subsection1 the term over-the-counter hearing aid means a device-- 7,a7 that uses the same fundamental scientific technology as air conduction hearing aids 7as defined in section #hgd4ccjj of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation7 or wireless air conduction hearing aids 7as defined in section #hgd4ccje of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation72 7,b7 that is intended to be used by adults over the age of #ah to compensate for perceived mild to moderate hearing impairment2 7,c7 that1 through tools1 tests1 or software1 allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs2 7,d7 that may-- 7i7 use wireless technology2 or 7ii7 include tests for self-assessment of hearing loss2 and 7,e7 that is available over-the-counter1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7#b7 ,regulation ,an over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section #b7;b7 of the ,over-the-,counter ,hearing ,aid ,act of #bjag and shall be exempt from sections #hja4dbj and #hja4dba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 4 7b7 ,regulations ,to establish category 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 not later than #c years after the date of enactment of this ,act1 shall promulgate proposed regulations to establish a category of over-the-counter hearing aids1 as defined in subsection 7p7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 as amended by subsection 7a71 and1 not later than #ahj days after the date on which the public comment period on the proposed regulations closes1 shall issue such final regulations4 7#b7 ,requirements ,in promulgating the regulations under paragraph 7#a71 the ,secretary shall-- 7,a7 include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids2 7,b7 include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids2 7,c7 include requirements for appropriate labeling of the over-the-counter hearing aid1 including how consumers may report adverse events1 any conditions or contraindications1 and any advisements to consult promptly with a licensed physician2 and 7,d7 describe the requirements under which the sale of over-the-counter hearing aids is permitted1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7#c7 ,premarket notification ,the ,secretary shall make findings under section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 to determine whether over-the-counter hearing aids 7as defined in section #ebj7p7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 require a report under section #eaj7k7 to provide reasonable assurance of safety and effectiveness4 7#d7 ,effect on state law ,no ,state or local government shall establish or continue in effect any law1 regulation1 order1 or other requirement specifically applicable to hearing products that would restrict or interfere with the servicing1 marketing1 sale1 dispensing1 use1 customer support1 or distribution of over-the-counter hearing aids 7as defined in section #ebj7p7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 through in-person transactions1 by mail1 or online1 that is different from1 in addition to1 or otherwise not identical to1 the regulations promulgated under this subsection1 including any ,state or local requirement for the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person for consumers to access over-the-counter hearing aids4 7c7 ,new guidance issued ,not later than the date on which final regulations are issued under subsection 7b71 the ,secretary shall update and finalize the draft guidance of the ,department of ,health and ,human ,services entitled1 ,regulatory ,requirements for ,hearing ,aid ,devices and ,personal ,sound ,amplification ,products1 issued on ,november #g1 #bjac4 ,such updated and finalized guidance shall clarify which products1 on the basis of claims or other marketing1 advertising1 or labeling material1 meet the definition of a device in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 and which products meet the definition of a personal sound amplification product1 as set forth in such guidance4