,,ii  #aagth ,,congress  #b;d ,session  
,s4 #djdc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #g1     
#bjbb,ms4 ,warren 7for herself1 ,mr4    
,grassley1 ,ms4 ,hassan1 and ,mrs4      
,blackburn7 introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to instruct the ,secretary of  
,health and ,human ,services to issue   
regulations regarding over-the-counter  
hearing aids4  #a4 ,short title ,this   
,act may be cited as the ,delivering    
,over-the-,counter ,hearing ,aids ,now  
,act4  #b4 ,findings ,congress finds the
 following3 7#a7 ,more than #ch1jjj1jjj 
individuals in the ,united ,states      
experience some degree of hearing loss4 
7#b7 ,difficulty hearing is reported by 
half of individuals #ge years and older1
 and nearly #a in #c individuals between
 the ages of #fe and #ge4  7#c7         
,individuals with hearing loss are at a 
greater risk of developing ,alzheimer's 

disease and ,alzheimer's disease related
 dementia4  7#d7 ,individuals in the    
,united ,states with hearing loss are   
more likely to experience feelings of   
loneliness and isolation1 which have    
been exacerbated by the ,,covid-#ai     
pandemic4  7#e7 ,despite the prevalence 
of hearing loss1 only #a in #e          
individuals who could benefit from a    
hearing aid use one4  7#f7 ,the high    
cost of hearing aids1 which are not     
generally covered by private health     
insurance plans or under traditional    
,medicare1 makes them prohibitively     
expensive for many individuals in the   
,united ,states and limits access4  7#g7
 ,the provisions addressing the         
regulation of over-the-counter hearing  
aids were enacted in #bjag as part of   
the ,,fda ,reauthorization ,act of #bjag
 7,public ,law #aae-eb71 which removes  
outdated regulations blocking consumer  
access to affordable hearing aids and   
allows certain types of hearing aids to 
be made available over-the-counter to   

individuals in the ,united ,states with 
mild to moderate hearing loss4  7#h7    
,the law required the ,food and ,drug   
,administration to issue implementing   
regulations not later than #c years     
following the date of enactment of the  
,,fda ,reauthorization ,act of #bjag    
7,public ,law #aae-eb71 but the ,food   
and ,drug ,administration did not issue 
a proposed rulemaking for more than #d  
years4  7#i7 ,the law further required  
the ,food and ,drug ,administration to  
issue a final rule not later than #ahj  
days following the end of the public    
comment period for the proposed rule4   
,the public comment period closed on    
,january #ah1 #bjbb4  #c4 ,instruction  
to issue final rule ,not later than #cj 
days after the date of enactment of this
 ,act1 the ,secretary of ,health and    
,human ,services shall issue a final    
rule to establish a category of         
over-the-counter hearing aids1 as       
defined in subsection 7q7 of section    
#ebj of the ,federal ,food1 ,drug1 and  

,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71  
as described in section #gji7;b7 of the 
,,fda ,reauthorization ,act of #bjag    
7,public ,law #aae-eb74