ESD

Product Code: ESD


Products Classified as ESD

1449Hearing Aid, Air ConductionHearing Aid.

Total Product Life Cycle (TPLC) Devices

1449Hearing Aid, Air ConductionHearing Aid.

FDA Consensus Standards

Hearing Aid, Air Conduction [32695]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [32308]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [31251]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [38689]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [32302]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [29591]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [33856]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [38629]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [33032]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [32307]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [31252]21 CFR §874.3300 🔎
Hearing Aid, Air Conduction [29583]21 CFR §874.3300 🔎

Pre-market Notifications for ESD

K130790LYRIC2PHONAK LLC
K081136LYRIC HEARING AIDINSOUND MEDICAL INC.
K021867INSOUND XT SERIES HEARING AIDINSOUND MEDICAL INC.
K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)SIEMENS HEARING INSTRUMENTS, INC.
K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSONIC INNOVATIONS, INC.
K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGENERAL HEARING INSTRUMENTS, INC.
K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)UNITRON INDUSTRIES, INC.
K974339UNITRON MODEL SOUND F/XD PROGRAMMABLEUNITRON INDUSTRIES, INC.
K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEUNITRON INDUSTRIES, INC.
K974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)RESOUND CORP.
K974242ARGOSY PROGRAMMABLE ONQUEARGOSY ELECTRONICS
K974211OPUS 2 - FULL CONCHA SERIES - ITEBERNAFON-MAICO, INC.
K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)BERNAFON-MAICO, INC.
K974129HI-69E, HI-69N, HI-69PROCKWIN CORP.
K974081RESOUND STEALTH CICRESOUND CORP.

Global Unique Device Identification Database

00698764455848Hearing aid, air conduction
00698764455800Hearing aid, air conduction
00698764455794Hearing aid, air conduction
00698764455787Hearing aid, air conduction
00698764442008Hearing aid, air conduction
00698764441995Hearing aid, air conduction
00698764441988Hearing aid, air conduction
00698764441919Hearing aid, air conduction
00698764441902Hearing aid, air conduction
00698764441896Hearing aid, air conduction
00698764441643Hearing aid, air conduction
00698764441636Hearing aid, air conduction
00698764441629Hearing aid, air conduction
00698764436700Hearing aid, air conduction
00698764436694Hearing aid, air conduction

Maude Adverse Events

HEARING AIDLISTEN CLEAR2020-01-17
EARGO NEO HEARING AIDEARGO, INC.2019-10-10
EARGO NEO HEARING AIDEARGO, INC.2019-10-10
EARGO NEO HEARING AIDEARGO, INC.2019-10-10
HEARING AID EARGOEARGO, INC.2019-09-20
HI-PRO 2, 1072NATUS MEDICAL DENMARK (GN OTOMETRICS)2019-09-03
STARKEY MUSE RICSTARKEY LABORATORIES INC.2019-07-17
STARKEY MUSE RICSTARKEY LABORATORIES INC.2019-07-17
SIGNIA MODEL ITE-INSIO-3NXSIVANTOS (SUZHOU) CO., LTD.2019-07-09
GENIUSSIVANTOS, INC2019-05-06
GENIUSMIRACLE-EAR, INC.2019-05-06
GENIUSMIRACLE-EAR, INC.2019-05-06
RESOUNDGN HEARING A/S2019-04-12
BELTONEGN HEARING A/S2019-04-03
RESOUNDGN HEARING A/S2019-02-19
RESOUNDGN HEARING A/S2019-02-01
PHONAK LYRIC HEARING AIDSONOVA AG2018-07-24
OTOVATION HEARING.COMOVATION HEARING/ WESTRIDGE MARKETING2018-05-24
MSA 30X HEARING AMPLIFIERGLOBAL TV CONCEPTS, LTD.2018-05-22
MUSE I1600 WIRELESSSTARKEY LAB HEARING AID CO.2018-05-21
MUSE I1600 WIRELESSSTARKEY LAB HEARING AID CO.2018-05-21
PHONAK RECEIVER IN THE CANAL (RIC) HEARING AID DOMEPHONAK LLC2018-04-20
GN RESOUND RECEIVER IN THE CANAL (RIC) H/AID DOME 7MMRICGM RESOUND2018-04-19
GN RESOUND RECEIVER IN THE CANAL (RIC) H/AID DOME 7MMRICGN RESOUND2018-04-19
RECEIVER IN THE CANAL HEARING AID/RICSIVANTOS INC.2018-04-19
GN RESOUND RECEIVER IN THE CANAL HEARING/AID DOME 7MM OPENGN RESOUND2018-04-19
PHONAK AUDIO V90 312 RICPHONAK LLC2018-04-19
RECEIVER IN THE CANAL HEARING AIDSIVANTOS, INC.2018-04-19
TURBO EAR SOUND AMPLIFIERGOLDEN AIM INTERNATIONAL LTD.2018-02-13
EARMATE-4220 "CRYSTAL"HEARING HELP EXPRESS2018-02-13
TURBO EAR SOUND AMPLIFIERGOLDEN AIM INTERNATIONAL LTD.2018-02-13
HEARING AID ("SIEMENS PURE BINAX")SIEMENS / SIGNIA2017-12-07
HEARING AID ("SIEMENS PURE BINAX")SIEMENS / SIGNIA/ SIVANTOS2017-12-07
SIEMENS HEARING AIDSIEMENS2017-11-28
SIEMENS HEARING AIDSIEMENS/ SIGNIA/ SIVANTOS2017-11-28
WIHEAR HEARING AIRAUSTAR-HEARING2017-11-22
NAIDA CI Q702017-08-15
NAIDA CI Q70ADVANCED BIONICS2017-08-15
SIGNIA HEARING SYSTEM BY SIEMENSSIVANTOS, INC.2017-07-20
EARGOEARGO, INC.2017-05-03
SENSEI BEHIND THE EAROTICON A/S2017-01-04
RESOUND LINX2 7622016-10-21
BAHA 4COCHLEAR AMERICAS2016-09-14
HEARING AIDAUDIBEL USA/ STARKEY HEARING TECHNOLOGIES2016-07-27
LYRIC 3 HEARING AIDPHONAK AG2016-04-04
LYRIC HEARING AIDPHONAK AG2016-03-31
LYRIC INVISIBLE IN-THE-CANAL HEARING AIDPHONAK2016-01-18
LYRIC INVISIBLE IN-THE-CANAL HEARING AIDPHONAK2016-01-18
EARGOEARGO, INC.2016-01-15
LEGEND 6BELTONE2015-12-29
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