,,ii  #aae? ,,congress  #a/ ,session    
,s4 #fgj  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #ba1 #bjag,ms4    
,w>r5 7= h]self1 ,mr4 ,grassley1 ,ms4   
,hassan1 & ,mr4 ,isakson7 introduc$ !   
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
provide = ! regulation ( ov]-!-c\nt]    
he>+ aids4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,ov]-!-,c\nt] ,he>+ ,aid
 ,act ( #bjag4  #b4 ,regulation (       
ov]-!-c\nt] he>+ aids  7a7 ,9 g5]al     
,section #ebj ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7  
is am5d$ by add+ at ! end ! foll[+3  7p7
 ,regulation ( ,ov]-!-,c\nt] he>+ aids  
7#a7 ,def9ition ,9 ?is subsection1 ! t]m
 ov]-!-c\nt] he>+ aid means a device--  
7,a7 t uses ! same fundam5tal sci5tific 
te*nology z air conduction he>+ aids 7z 
def9$ 9 section #hgd4ccjj ( title #ba1  
,code ( ,f$]al ,regulations7 7or any    
successor regulation7 or wireless air   
conduction he>+ aids 7z def9$ 9 section 

#hgd4ccje ( title #ba1 ,code ( ,f$]al   
,regulations7 7or any successor         
regulation72  7,b7 t is int5d$ to be us$
 by adults ov] ! age ( #ah to comp5sate 
= p]ceiv$ mild to mod]ate he>+          
impairm5t2  7,c7 t1 ?r\gh tools1 te/s1  
or s(tw>e1 all[s ! us] to control !     
ov]-!-c\nt] he>+ aid & cu/omize x to !  
us]'s he>+ ne$s2  7,d7 t may-- 7i7 use  
wireless te*nology2 or  7ii7 include    
te/s = self-assessm5t ( he>+ loss2 &    
7,e7 t is available ov]-!-c\nt]1 )\t !  
sup]vision1 prescription1 or o!r ord]1  
involvem5t1 or int]v5tion ( a lic5s$    
p]son1 to consum]s ?r\gh 9-p]son        
transactions1 by mail1 or onl9e4  7#b7  
,regulation ,an ov]-!-c\nt] he>+ aid    
%all be subject to ! regulations        
promulgat$ 9 accordance ) section #b7;b7
 ( ! ,ov]-!-,c\nt] ,he>+ ,aid ,act (    
#bjag & %all be exempt f sections       
#hja4dbj & #hja4dba ( title #ba1 ,code (
 ,f$]al ,regulations 7or any successor  
regulations74  4  7b7 ,regulations ,to  
e/abli% category  7#a7 ,9 g5]al ,!      

,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y71
 n lat] ?an #c ye>s aft] ! date (       
enactm5t ( ?is ,act1 %all promulgate    
propos$ regulations to e/abli% a        
category ( ov]-!-c\nt] he>+ aids1 z     
def9$ 9 subsection 7p7 ( section #ebj ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;j7 z am5d$ by       
subsection 7a71 &1 n lat] ?an #ahj days 
aft] ! date on :i* ! public comm5t p]iod
 on ! propos$ regulations closes1 %all  
issue su* f9al regulations4  7#b7       
,requirem5ts ,9 promulgat+ ! regulations
 "u p>agraph 7#a71 ! ,secret>y %all--   
7,a7 include requirem5ts t provide      
reasonable assurances ( ! safety &      
efficacy ( ov]-!-c\nt] he>+ aids2  7,b7 
include requirem5ts t e/abli% or adopt  
output limits appropriate = ov]-!-c\nt] 
he>+ aids2  7,c7 include requirem5ts =  
appropriate label+ ( ! ov]-!-c\nt] he>+ 
aid1 includ+ h[ consum]s may report     
adv]se ev5ts1 any conditions or         
contra9dications1 & any advisem5ts to   

consult promptly ) a lic5s$ physician2 &
  7,d7 describe ! requirem5ts "u :i* !  
sale ( ov]-!-c\nt] he>+ aids is p]mitt$1
 )\t ! sup]vision1 prescription1 or o!r 
ord]1 involvem5t1 or int]v5tion ( a     
lic5s$ p]son1 to consum]s ?r\gh 9-p]son 
transactions1 by mail1 or onl9e4  7#c7  
,prem>ket notification ,! ,secret>y %all
 make f9d+s "u section #eaj7m7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7m77 to det]m9e :e!r 
ov]-!-c\nt] he>+ aids 7z def9$ 9 section
 #ebj7p7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z
 am5d$ by subsection 7a77 require a     
report "u section #eaj7k7 to provide    
reasonable assurance ( safety &         
effectiv5ess4  7#d7 ,effect on /ate law 
,no ,/ate or local gov]nm5t %all e/abli%
 or cont9ue 9 effect any law1           
regulation1 ord]1 or o!r requirem5t     
specifically applicable to he>+ products
 t w\ld re/rict or int]f]e ) ! s]vic+1  
m>ket+1 sale1 disp5s+1 use1 cu/om]      
support1 or di/ribution ( ov]-!-c\nt]   

he>+ aids 7z def9$ 9 section #ebj7p7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;j71 z am5d$ by      
subsection 7a77 ?r\gh 9-p]son           
transactions1 by mail1 or onl9e1 t is   
diff]5t f1 9 addition to1 or o!rwise n  
id5tical to1 ! regulations promulgat$ "u
 ?is subsection1 includ+ any ,/ate or   
local requirem5t = ! sup]vision1        
prescription1 or o!r ord]1 involvem5t1  
or int]v5tion ( a lic5s$ p]son =        
consum]s to access ov]-!-c\nt] he>+     
aids4  7c7 ,new guidance issu$ ,n lat]  
?an ! date on :i* f9al regulations are  
issu$ "u subsection 7b71 ! ,secret>y    
%all update & f9alize ! draft guidance (
 ! ,dep>tm5t ( ,heal? & ,human ,s]vices 
entitl$1 ,regulatory ,requirem5ts =     
,he>+ ,aid ,devices & ,p]sonal ,s\nd    
,amplification ,products1 issu$ on      
,novemb] #g1 #bjac4 ,su* updat$ &       
f9aliz$ guidance %all cl>ify :i*        
products1 on ! basis ( claims or o!r    
m>ket+1 adv]tis+1 or label+ mat]ial1    
meet ! def9ition ( a device 9 section   

#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 &   
:i* products meet ! def9ition ( a       
p]sonal s\nd amplification product1 z   
set =? 9 su* guidance4