<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns:m="http://schemas.microsoft.com/office/2004/12/omml" xmlns="http://www.w3.org/TR/REC-html40"><head><meta http-equiv=Content-Type content="text/html; charset=utf-8"><meta name=Generator content="Microsoft Word 15 (filtered medium)"><!--[if !mso]><style>v\:* {behavior:url(#default#VML);}
o\:* {behavior:url(#default#VML);}
w\:* {behavior:url(#default#VML);}
.shape {behavior:url(#default#VML);}
</style><![endif]--><style><!--
/* Font Definitions */
@font-face
{font-family:Wingdings;
panose-1:5 0 0 0 0 0 0 0 0 0;}
@font-face
{font-family:"Cambria Math";
panose-1:2 4 5 3 5 4 6 3 2 4;}
@font-face
{font-family:Calibri;
panose-1:2 15 5 2 2 2 4 3 2 4;}
/* Style Definitions */
p.MsoNormal, li.MsoNormal, div.MsoNormal
{margin:0in;
font-size:11.0pt;
font-family:"Calibri",sans-serif;}
h1
{mso-style-priority:9;
mso-style-link:"Heading 1 Char";
mso-margin-top-alt:auto;
margin-right:0in;
mso-margin-bottom-alt:auto;
margin-left:0in;
font-size:24.0pt;
font-family:"Calibri",sans-serif;
font-weight:bold;}
a:link, span.MsoHyperlink
{mso-style-priority:99;
color:blue;
text-decoration:underline;}
span.Heading1Char
{mso-style-name:"Heading 1 Char";
mso-style-priority:9;
mso-style-link:"Heading 1";
font-family:"Calibri Light",sans-serif;
color:#2F5496;}
span.EmailStyle23
{mso-style-type:personal-reply;
font-family:"Calibri",sans-serif;
color:windowtext;}
.MsoChpDefault
{mso-style-type:export-only;
font-size:10.0pt;}
@page WordSection1
{size:8.5in 11.0in;
margin:1.0in 1.0in 1.0in 1.0in;}
div.WordSection1
{page:WordSection1;}
/* List Definitions */
@list l0
{mso-list-id:1863592245;
mso-list-template-ids:1034701400;}
@list l0:level1
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Symbol;}
@list l0:level2
{mso-level-number-format:bullet;
mso-level-text:o;
mso-level-tab-stop:1.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:"Courier New";
mso-bidi-font-family:"Times New Roman";}
@list l0:level3
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:1.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level4
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:2.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level5
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:2.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level6
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:3.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level7
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:3.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level8
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:4.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level9
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:4.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
ol
{margin-bottom:0in;}
ul
{margin-bottom:0in;}
--></style><!--[if gte mso 9]><xml>
<o:shapedefaults v:ext="edit" spidmax="1026" />
</xml><![endif]--><!--[if gte mso 9]><xml>
<o:shapelayout v:ext="edit">
<o:idmap v:ext="edit" data="1" />
</o:shapelayout></xml><![endif]--></head><body lang=EN-US link=blue vlink=purple style='word-wrap:break-word'><div class=WordSection1><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><o:p> </o:p></p><div><p class=MsoNormal>Steve Cook<o:p></o:p></p><p class=MsoNormal>If you would like to join the Computer Science & Technology Division for the NFB of SC list serve, please send a message to <a href="mailto:SC-cstd-subscribe@nfbnet.org">SC-cstd-subscribe@nfbnet.org</a><o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>National Association of Guide Dog Users Board Member<o:p></o:p></p><p class=MsoNormal>President of the Computer Science & Technology Division of the National Federation of the Blind of SC<o:p></o:p></p><p class=MsoNormal>1<sup>st</sup> Vice President of the Columbia chapter of the National Federation of the Blind of SC<o:p></o:p></p><p class=MsoNormal>1<sup>st</sup> Vice President of the SC Association of Guide Dog Users Division<o:p></o:p></p></div><div><p>Hearing News Watch - Thursday, October 13, 2022 at 11:23 PM<o:p></o:p></p><h1>FDA Offers Clarification to States Regarding Final OTC Hearing Aid Rule<o:p></o:p></h1><p class=MsoNormal><img border=0 id="_x0000_i1030" src="https://hearinghealthmatters.org/hearingnewswatch/files/2020/11/otc-hearing-aids.jpg"><o:p></o:p></p><p><em><span style='font-family:"Calibri",sans-serif'>WASHINGTON, D.C.</span></em> — Today, the U.S. Food and Drug Administration (FDA) sent a letter to state officials offering clarifications about the Final Rule on OTC Hearing Aids, following <a href="https://hearinghealthmatters.org/hearingnewswatch/2022/academy-audiology-prescription-hearing-aid-fda/">requests</a> by several professional organizations seeking to better understand the distinction between ‘Prescription’ and ‘OTC’ hearing aid categories.<o:p></o:p></p><p>In part, the letter states, <em><span style='font-family:"Calibri",sans-serif'>“We have received questions about some implications of these actions, including who may prescribe hearing aids and whether medical evaluations are necessary to obtain non-OTC hearing aids, which will be defined as prescription hearing aids under the rule. We clarify below that the final rule:</span></em><o:p></o:p></p><ul type=disc><li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;mso-list:l0 level1 lfo1'><em><span style='font-family:"Calibri",sans-serif'>Does not change the necessary qualifications of who may provide hearing healthcare with prescription hearing aids, including the recommendation, selection, fitting, and dispensing of these devices;</span></em><o:p></o:p></li><li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;mso-list:l0 level1 lfo1'><em><span style='font-family:"Calibri",sans-serif'>Does not require an additional professional to take actions, for example, does not in any way require a physician’s involvement prior to fitting these devices; and</span></em><o:p></o:p></li><li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;mso-list:l0 level1 lfo1'><em><span style='font-family:"Calibri",sans-serif'>Does not require an examination of any kind to obtain a prescription hearing aid.</span></em><o:p></o:p></li></ul><p>This FDA letter was issued in response to requests by the Academy of Doctors of Audiology (ADA) and other organizations that the FDA provide clarification regarding implications for the Final Rule and the re-categorization of non-OTC hearing aids as prescription devices.<o:p></o:p></p><p>While this action does not negate the need for audiologists to advocate for timely updates to state regulations and statutes in response to the new regulations, it does provide states with an understanding of the FDA’s position, including …<o:p></o:p></p><p><em><span style='font-family:"Calibri",sans-serif'>“the final rule defining non-OTC hearing aids as prescription devices does not, and is not intended to, create barriers to accessing hearing aids, including prescription devices. It does not require the involvement of different or additional health care providers or examinations upon the effective date.”</span></em><o:p></o:p></p><p>It is unclear what immediate impact the clarification letter may have on state actions related to OTC and prescription hearing aids.<o:p></o:p></p><p><strong><span style='font-family:"Calibri",sans-serif'><a href="https://hearinghealthmatters.org/hearingnewswatch/files/2022/10/Dear_State_Official_Re_OTC_Hearing_Aids_.pdf">Read full letter here</a></span></strong><o:p></o:p></p><p><strong><i><span style='font-family:"Calibri",sans-serif'>Source:</span></i></strong><em><span style='font-family:"Calibri",sans-serif'> <a href="https://www.audiologist.org/resources/communications/in-the-news/item/fda-provides-important-clarification-to-states-regarding-final-fda-rule-on-otc-hearing-aids">ADA</a></span></em><o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p><a href="https://hearinghealthmatters.org/hearingnewswatch/2022/fda-state-clarity-otc-hearing-aids/">https://hearinghealthmatters.org/hearingnewswatch/2022/fda-state-clarity-otc-hearing-aids/</a><o:p></o:p></p><p class=MsoNormal><span style='color:white'><o:p> </o:p></span></p></div></div></body></html>