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Panels › Ear, Nose, Throat › Product code ESD · Class 1

Hearing Aid, Air-Conduction, Prescription

Regulation 874.3300

0510(k)s in 12 months (1,367 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
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Top companies in ESD

Decided510(k)Device and applicantCode
Apr 11, 2024K232999Lyric4 Hearing Aid
Sonova AG, CH
ESD
Jun 27, 2013K130790LYRIC2
Phonak, LLC
ESD
May 8, 2008K081136LYRIC HEARING AID
Insound Medical, Inc.
ESD
Nov 19, 2002K021867INSOUND XT SERIES HEARING AID
Insound Medical, Inc.
ESD
Apr 24, 2001K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Siemens Hearing Instruments, Inc.
ESD
Mar 12, 1999K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
Sonic Innovations, Inc.
ESD
Mar 6, 1998K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
General Hearing Instruments, Inc.
ESD
Jan 20, 1998K974242ARGOSY PROGRAMMABLE ONQUE
Argosy Electronics
ESD
Jan 12, 1998K973880SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
Sonix Technologies, Inc.
ESD
Dec 15, 1997K974211OPUS 2 - FULL CONCHA SERIES - ITE
Bernafon-Maico, Inc.
ESD
Dec 15, 1997K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
Bernafon-Maico, Inc.
ESD
Dec 15, 1997K974069OPUS 2 - CANAL SERIES (ITC)
Bernafon-Maico, Inc.
ESD
Dec 12, 1997K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
Unitron Industries, Inc.
ESD
Dec 12, 1997K974339UNITRON MODEL SOUND F/XD PROGRAMMABLE
Unitron Industries, Inc.
ESD
Dec 12, 1997K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
Unitron Industries, Inc.
ESD
Dec 12, 1997K974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
Resound Corp.
ESD
Dec 12, 1997K974129HI-69E, HI-69N, HI-69P
Rockwin Corp.
ESD
Dec 12, 1997K974081RESOUND STEALTH CIC
Resound Corp.
ESD
Dec 11, 1997K973927HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
Hyunjae Corp.
ESD
Nov 19, 1997K973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
Magnatone Hearing Aid Corp.
ESD
Nov 4, 1997K973972PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
Perfect Ear
ESD
Nov 4, 1997K973886OTICON DIGISOUND COMPACT
Oticon, Inc.
ESD
Nov 4, 1997K973885OTICON DIGISOUND ITE
Oticon, Inc.
ESD
Nov 4, 1997K973665MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
Magnatone Hearing Aid Corp.
ESD
Oct 29, 1997K973846AIR CONDUCTION HEARING AID
Baron Trading, Inc.
ESD
Oct 28, 1997K973948DUALINE 100 BTE
Bernafon-Maico, Inc.
ESD
Oct 28, 1997K973579AM SERIES HEARING AID
A & M Hearing, Ltd., GB
ESD
Oct 27, 1997K973043MODEL C-1 HEARING AID
Better Hearing, Inc.
ESD
Oct 17, 1997K972818D72 DIGITAL
Philips Hearing Instruments Co.
ESD
Oct 14, 1997K973376LORI/LORI, LORI-S (LORI STOCK AID)
Lori Medical Laboratories, Inc.
ESD
Sep 23, 1997K973266Z DEQ-II
Electone, Inc.
ESD
Sep 8, 1997K972776DRY & STORE
Ear Technology Corp.
ESD
Sep 5, 1997K972998PRISMA
Siemens Hearing Instruments, Inc.
ESD
Aug 25, 1997K972039NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
Nu-Sound
ESD
Aug 15, 1997K972106PHONAK NOVO FORTE E3
Phonak, Inc.
ESD
Aug 15, 1997K972058LORIPRO, LORIPRO II
Lori Medical Laboratories, Inc.
ESD
Aug 15, 1997K971852AIR CONDUCTION HAEARING AIDS
Beltone Electronics Corp.
ESD
Aug 15, 1997K971845HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
Sound Hearing Instruments, Inc.
ESD
Aug 7, 1997K971807IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
Hear-Right, Inc.
ESD
Aug 5, 1997K972755V-12 LONG LIFE 675 HEARING AID
Vista Labs
ESD
Aug 1, 1997K972105PHONAK EPICA
Phonak, Inc.
ESD
Jul 31, 1997K972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
Trutone
ESD
Jul 30, 1997K972552AUDIFON H20 PC/AUDIFON H32 PP
Trutone
ESD
Jul 30, 1997K972097PHONAK MICROZOOM P 2
Phonak, Inc.
ESD
Jul 29, 1997K972373OVATION HDP
Orsonique, Inc., CA
ESD
Jul 23, 1997K972543TWIST PPAGC-1, TWIST PP
Trutone
ESD
Jul 23, 1997K972542JAZZ PP AGC-O, JAZZ PP
Trutone
ESD
Jul 23, 1997K972431MERIDIAN DSP
Micro-Ear Technology, Inc.
ESD
Jul 23, 1997K972346MIRACLE-EAR ITE DIGITAL
Miracle-Ear, Inc.
ESD
Jul 23, 1997K972345DAHLBERG/MIRACLE-EAR
Miracle-Ear, Inc.
ESD

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