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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
May 4, 1994K941635INTRA S, INTRA SH
Starkey Laboratories, Inc.
ESD
May 4, 1994K941508WIDEX S-21
Widex Hearing Aid Co., Inc.
ESD
May 4, 1994K941395BELTON MERIT (HEARING AID)
Beltone Electronics Corp.
ESD
May 4, 1994K941140RIONET HEARING AID HB-37T
Authorized Hearing Systems, Inc.
ESD
May 4, 1994K941021RIONET HEARING AID HB-54
Authorized Hearing Systems, Inc.
ESD
May 4, 1994K940978STARKEY EUROLINE A SERIES
Starkey Laboratories, Inc.
ESD
May 4, 1994K940608155 PP AGC-I
Danavox, Inc.
ESD
May 4, 1994K935962MIRACLE-EAR WITH POWER CIRCUIT OPTION
Miracle-Ear, Inc.
ESD
May 3, 1994K940116COMPLETELY IN THE CANAL
Argosy Electronics
ESD
Apr 4, 1994K936190BEHIND THE EAR HEARING AID
Audina Hearing Instrument
ESD
Apr 1, 1994K940177OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
Beltone Electronics Corp.
ESD
Apr 1, 1994K940103BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND
Beltone Electronics Corp.
ESD
Apr 1, 1994K940102BELTONE OPERA/OPERA MHP/OPERA MAX
Beltone Electronics Corp.
ESD
Apr 1, 1994K940101OTOSONIC ACS II D WITH SRR
Beltone Electronics Corp.
ESD
Apr 1, 1994K940100PROFILE IC; PROFILE CLEARVOICE; PROFILE
Beltone Electronics Corp.
ESD
Apr 1, 1994K940099OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP
Beltone Electronics Corp.
ESD
Mar 25, 1994K940639LORI-CIC HEARING AID
Lori Medical Laboratories, Inc.
ESD
Mar 24, 1994K940104OTOSONIC MINI PAS
Beltone Electronics Corp.
ESD
Mar 22, 1994K935867AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
Unitron Industries, Inc.
ESD
Mar 21, 1994K940458MIRACLE-EAR CONFIDANTE
Miracle-Ear, Inc.
ESD
Mar 21, 1994K936122RIONET HEARING AID HB-53CI
Authorized Hearing Systems, Inc.
ESD
Mar 21, 1994K936106AIR CONDUCTION HEARING AID: IKON PP
Unitron Industries, Inc.
ESD
Mar 17, 1994K935424WIDEX R.C. 2 (REMOTE CONTROL)
Widex Hearing Aid Co., Inc.
ESD
Mar 7, 1994K934940MIRACLE-EAR ENTRE
Miracle-Ear, Inc.
ESD
Mar 4, 1994K936007PRIZM HEARING SYSTEM, MODEL POWER BTE
Audioscience, Inc.
ESD
Jan 27, 1994K935559HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
Rockwin Corp.
ESD
Jan 26, 1994K935791PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
Phonak, Inc.
ESD
Jan 21, 1994K935335NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935334NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935333NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935332NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935331NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935330NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935329NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935328NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935327NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
Nu-Ear Electronics
ESD
Jan 21, 1994K935326NU-EAR SD-10 IN THE CANAL HEARING AID
Nu-Ear Electronics
ESD
Jan 13, 1994K935366BINAURAL HEARING AID
Telex Communications, Inc.
ESD
Jan 5, 1994K935458AUDIPHON, MODEL H-11
National Hearing Aid Dist., Inc.
ESD
Dec 27, 1993K934149MICRO-TECH TRU CANAL
Micro-Ear Technology, Inc.
ESD
Dec 22, 1993K935289PRO FIT-CYBER II OPTION
Qualitone
ESD
Dec 15, 1993K935420SOUNDRIGHT, SHP
Soundright Hearing Products
ESD
Dec 15, 1993K935266MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
Miracle-Ear, Inc.
ESD
Dec 15, 1993K935265MIRACLE EAR MODEL SHARP II CANAL
Miracle-Ear, Inc.
ESD
Dec 15, 1993K9350958260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
3M Company
ESD
Dec 15, 1993K933963PAL (PERSONAL AMPLIFIER FOR LISTENING)
Hearing Care Products, Inc.
ESD
Nov 29, 1993K934565UNITRON MODEL IKON AGCO/ AOD
Unitron Industries, Inc.
ESD
Nov 29, 1993K934417OMNI 2000 SERIES ITC HEARING AID
Starkey Laboratories, Inc.
ESD
Nov 29, 1993K934416OMNI 2000 SERIES ITE HEARING AID
Starkey Laboratories, Inc.
ESD
Nov 19, 1993K934618OTOSONIC ADVANCED FULL SHIELD (AFS)
Beltone Electronics Corp.
ESD

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