BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 16.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:STANDARD DTSTART:16011104T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=11 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 END:STANDARD BEGIN:DAYLIGHT DTSTART:16010311T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYMONTH=3 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT CLASS:PUBLIC CREATED:20211115T204139Z DESCRIPTION:Date/Time: December 07\, 2021 (Tuesday)\, from 1 – 2 pm ET\n \nBackground:\nThe U.S. Food and Drug Administration (FDA)\, Center for De vices and Radiological Health (CDRH)\, will host a public webinar about:\n \n* proposed rule “Establishing Over-the-Counter Hearing Aids ” and\n* draft guidance “Regulatory Requirements for Hearing Aid Devices a nd Personal Sound Amplification Products ”\n \nDuring this webinar\, the FDA will provide highlights of these two regulatory document s and will answer questions from webinar attendees.\n \n \nWebinar Connect ion Details\nWe encourage you to join at least 15 minutes prior to the sta rt of the webinar. You do not need to register to attend. We recommend you join using the Zoom link below\, if possible:\n \n* Webinar Link : https: //fda.zoomgov.com/j/1602431947?pwd=OGZGT2dXbEszT3NxWnVsVW5MMllBZz09 \n* Pa sscode: yQb#C9\n \nIf you join by phone only without the Zoom link:\n* Dia l: +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 137 3 or 833 568 8864 (Toll Free) \n* Webinar ID: 160 243 1947\n* Passcode: 62 6002\n DTEND;TZID="Eastern Standard Time":20211207T140000 DTSTAMP:20211115T204139Z DTSTART;TZID="Eastern Standard Time":20211207T130000 LAST-MODIFIED:20211115T204139Z PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Proposed Rule for Establishing Ov er-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplication Products (PSAPs) TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000020D74D4634DAD701000000000000000 01000000046AC0FB96192054F96B99B279CBD7066 X-ALT-DESC;FMTTYPE=text/html:

Date/Time: December 07\, 2021 (Tuesday )\, from 1 –\; 2 pm ET

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Background:

The U.S. Food and Drug Administration (FDA)\, Center for Devices and Radiological Health (CDRH)\, will host a public webinar about:

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 \;

During this webin ar\, the FDA will provide highlights of these two regulatory documents and will answer questions from webinar attendees.

 \;

 \;

Webinar Connection Details

We encourage you to join at least 15 minutes prior to the start of the webinar. You do not need to register to attend. We recommend you join using the Zoom link below\, if possible:

 \;

 \;

If you join by phone only without the Zoo m link:

  • Dial: +1 669 254 5252 or +1 646 828 7666 o r +1 669 216 1590 or +1 551 285 1373 or 833 568 8864 (Toll Free) \;
  • W ebinar ID: 160 243 1947
  • Passcode: 626002
X-MICROSOFT-CDO-BUSYSTATUS:BUSY X-MICROSOFT-CDO-IMPORTANCE:1 X-MICROSOFT-DISALLOW-COUNTER:FALSE X-MS-OLK-CONFTYPE:0 BEGIN:VALARM TRIGGER:-PT15M ACTION:DISPLAY DESCRIPTION:Reminder END:VALARM END:VEVENT END:VCALENDAR