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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

Company510(k)sRecalls
Unitron Industries, Inc.690
Miracle-Ear, Inc.640
Electone, Inc.630
Oticon Corp.630
Widex Hearing Aid Co., Inc.510
Rion Acoustic Instruments, Inc.470
Starkey Laboratories, Inc.390
Telex Communications, Inc.390
Phonak, Inc.370
Beltone Electronics Corp.360
Decided510(k)Device and applicantCode
Apr 10, 1996K960680RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
Resound Corp.
ESD
Apr 5, 1996K960804MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
Miracle-Ear, Inc.
ESD
Apr 4, 1996K960410PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
Perfect Ear
ESD
Apr 3, 1996K960935AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)
Hearing Solutions, Inc.
ESD
Mar 22, 1996K960295LONG LIFE RX-12
Rexton, Inc.
ESD
Mar 12, 1996K960052RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
Resound Corp.
ESD
Mar 7, 1996K960284OTICON /PRIMOFOCUS (PF)
Oticon, Inc.
ESD
Mar 7, 1996K960155UNITRON MODEL SOUND F/XP
Unitron Industries, Inc.
ESD
Mar 7, 1996K960031AUDIOFLEX 120
Maico Hearing Instruments, Inc.
ESD
Mar 1, 1996K960494EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
Starkey Laboratories, Inc.
ESD
Mar 1, 1996K955930BELTONE COMPOSER 2000 BTE HP
Beltone Electronics Corp.
ESD
Feb 27, 1996K955879WIDEX MODEL SENSO DIGITAL (C16)
Widex Hearing Aid Co., Inc.
ESD
Feb 22, 1996K955702SONATA U-01
Electone, Inc.
ESD
Feb 13, 1996K955466DYNAMEQ-II OPTION
Qualitone
ESD
Feb 12, 1996K955878WIDEX MODEL SENSO DIGITAL (C8)
Widex Hearing Aid Co., Inc.
ESD
Feb 2, 1996K955867RESOUND PERSONAL HEARING SYSTEM BT247
Resound Corp.
ESD
Feb 2, 1996K955692FINETONE FSC,
Finetone Hearing Instruments
ESD
Feb 2, 1996K955288HEARING AID IMPRESSION MATERIAL
Crown Delta Corp.
ESD
Jan 24, 1996K954119MIRACLE EAR MIRAGE
Miracle-Ear, Inc.
ESD
Jan 17, 1996K954922REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
Rexton, Inc.
ESD
Dec 22, 1995K955574RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
Resound Corp.
ESD
Dec 22, 1995K954941MIRACLE EAR AND AUDIOTONE
Miracle-Ear, Inc.
ESD
Dec 19, 1995K955359CYBER III OPTION UM, UC312, UC10, UCIC
Qualitone
ESD
Dec 8, 1995K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
Telex Communications, Inc.
ESD
Dec 6, 1995K954936BELTONE ULTIMA 80 OTOSONIC POWER PAS
Beltone Electronics Corp.
ESD
Dec 6, 1995K954236FACEPLATE (HEARING AID KIT)
Truetone Hearing Systems, Inc.
ESD
Nov 13, 1995K954937COAST HEARING CHS (CUSTOM HEARING SYSTEM)
Coast Hearing Services
ESD
Nov 13, 1995K954794OTICON
Oticon, Inc.
ESD
Nov 13, 1995K953603HEARING TODAY HEARING AID
Hearing Today Laboratory, Inc.
ESD
Oct 18, 1995K954526WIDEX SENSO DIGITAL (PX)
Widex Hearing Aid Co., Inc.
ESD
Oct 7, 1995K954528MIRACLE - EAR MODEL PBP
Miracle-Ear, Inc.
ESD
Oct 7, 1995K954516UNITRON MODEL SOUND F/X II
Unitron Industries, Inc.
ESD
Oct 7, 1995K953932UNITRON MODEL SOUND F/XD
Unitron Industries, Inc.
ESD
Oct 7, 1995K953727UNITRON MODEL IKON AOHPD
Unitron Industries, Inc.
ESD
Oct 6, 1995K954430UNITRON MODEL SOUND F/X
Unitron Industries, Inc.
ESD
Sep 28, 1995K9540673M MODEL 8295
3M Company
ESD
Sep 28, 1995K954054MAICO PRODIGY CIC SERIES
Maico Hearing Instruments, Inc.
ESD
Sep 18, 1995K954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT
Argosy Electronics
ESD
Sep 18, 1995K953921PHONAK 9900 CIC
Phonak, Inc.
ESD
Sep 18, 1995K953770REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
Rexton, Inc.
ESD
Sep 18, 1995K951002AMENDMENTS TO MULTIFOCUS
Oticon A/S, DK
ESD
Sep 12, 1995K953960HEARING AID (ALL-IN-THE-EAR)
Audina Hearing Instrument
ESD
Sep 12, 1995K953729K AMP FULL SHELL AND IN THE EAR
Midwest City Hearing Aid Center
ESD
Sep 12, 1995K953728RX12 LINEAR FULL SHELL AND IN THE CANAL
Midwest City Hearing Aid Center
ESD
Sep 12, 1995K951712HEARING AID (ALL-IN-THE-EAR)
Omega Hearing Aid Center
ESD
Aug 28, 1995K953646UNITRON MODEL IKON AOHPL
Unitron Industries, Inc.
ESD
Aug 28, 1995K953631SNIP INPUT COMPRESSION CLASS A
Midwest City Hearing Aid Center
ESD
Aug 23, 1995K9535433M MODEL 8200P MULTIPRO BTE
3M Company
ESD
Aug 23, 1995K945439PHONAK PICONET 232X-AZ HEARING INSTRUMENT
Phonak, Inc.
ESD
Aug 22, 1995K953050Z33
Electone, Inc.
ESD

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