,,ii  #aad? ,,congress  #b;d ,session   
,s4 #i  ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ 
,,/ates  ,decemb] #a1 #bjaf ,ms4 ,w>r5  
7= h]self & ,mr4 ,grassley7 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 ( #bjaf4  #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  7o7
 ,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 to comp5sate = p]ceiv$ mild  
to mod]ate he>+ impairm5t2  7,c7 t      
includes tools to all[ ! 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 (    
#bjaf & %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 7o7 ( 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* ! propos$ regulations
 are issu$1 %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>+ aids1 su* z appropriate
 consum] label+2 &  7,b7 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
 #ebj7o7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;j7o771 z am5d$ 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     
relat$ to ! manufactur+1 m>ket+1 sale1  
cu/om] support1 or di/ribution (        
ov]-!-c\nt] he>+ aids 7z def9$ 9 section
 #ebj7o7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;j7o771 z am5d$ 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 subsection4  7c7      
,guidance  7#a7 ,)drawal ( guidance     
7,a7 ,)drawal ,effective z ( ! date (   
enactm5t ( ?is ,act1 ! ,secret>y %all n 

use ! 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 #bjac1
 z ! basis = any prem>ket review "u !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cja et seq47 or = any   
relat$ compliance or en=cem5t decisions 
or actions4  7,b7 ,int]im guidance      
,until su* "t z new f9al guidance is    
issu$ "u p>agraph 7#b7 to replace !     
guidance describ$ 9 subp>agraph 7,a71 ! 
draft guidance entitl$ 8,guidance =     
,indu/ry & ,,fda ,/aff3 ,regulatory     
,requirem5ts = ,he>+ ,aid ,devices &    
,p]sonal ,s\nd ,amplification           
,products10 issu$ on ,febru>y #be1      
#bjji1 %all be 9 effect4  7#b7 ,new     
guidance issu$ ,n lat] ?an ! date on :i*
 f9al regulations are issu$ "u          
subsection 7b71 ! ,secret>y %all update 
! draft guidance describ$ 9 p>agraph    
7#a77;,a74 ,su* updat$ 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 device1 z 
def9$ 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