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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
Nov 3, 1989K894176FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
Precision Hearing Instruments
ESD
Oct 24, 1989K8951343M INSTANT FIT CUSTOM EARMOLD
3M Company
ESD
Oct 24, 1989K894428HEARING AID (IN-THE-EAR)
Hearing Aid Express
ESD
Oct 11, 1989K895140CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
Oticon Corp.
ESD
Sep 27, 1989K894414HEARING AID (IN-THE-CANAL)
Hearing Aid Express
ESD
Sep 8, 1989K893723LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
Lori Medical Laboratories, Inc.
ESD
Sep 8, 1989K893722LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
Lori Medical Laboratories, Inc.
ESD
Sep 8, 1989K893721LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
Lori Medical Laboratories, Inc.
ESD
Aug 15, 1989K893528OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
Oticon Corp.
ESD
Aug 8, 1989K892898ASTRO BEHIND-THE-EAR HEARING AID
Rexton, Inc.
ESD
Aug 4, 1989K893927RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
Resound Corp.
ESD
Aug 4, 1989K893432PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
Electone, Inc.
ESD
Aug 3, 1989K892338BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
Qualitone
ESD
Jul 14, 1989K891916ITE PRESCRIPTION SERIES MODEL PP + F
Us Hearing Centers, Inc.
ESD
Jul 14, 1989K891915ITE PRESCRIPTION SERIES MODEL LP
Us Hearing Centers, Inc.
ESD
Jun 22, 1989K892803PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
United Hearing Systems, Inc.
ESD
Jun 16, 1989K890271ALPHA MODEL I ITE HEARING AID
Alpha Instruments, Inc.
ESD
Jun 14, 1989K893433PERSONAL AMPLIFIER MODEL ULTRA HELIX
Electone, Inc.
ESD
Jun 6, 1989K892460TELSTAR MODEL PP ITE HEARING AID
Telstar Electronics, Inc.
ESD
Jun 6, 1989K892459TELSTAR MODEL C ITE HEARING AID
Telstar Electronics, Inc.
ESD
Jun 6, 1989K892458TELSTAR MODEL F ITE HEARING AID
Telstar Electronics, Inc.
ESD
Jun 6, 1989K892457TELSTAR MODEL 1/3 ITE HEARING AID
Telstar Electronics, Inc.
ESD
May 19, 1989K892336BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
Qualitone
ESD
May 19, 1989K892333REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
Rexton, Inc.
ESD
May 19, 1989K890525INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
Magnatone Hearing Aid Corp.
ESD
May 11, 1989K890102ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
Hear Clear, Inc.
ESD
May 10, 1989K892337BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
Qualitone
ESD
May 10, 1989K891594CERUMEN FILTER
Gn Danavox, Inc.
ESD
Mar 31, 1989K891251BEHIND-THE-EAR HEARING AID MODEL 408 W-H
Siemens Hearing Instruments, Inc.
ESD
Mar 29, 1989K891250BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
Siemens Hearing Instruments, Inc.
ESD
Mar 29, 1989K891249BEHIND-THE-EAR HEARING AID MODEL 303 ASP
Siemens Hearing Instruments, Inc.
ESD
Mar 29, 1989K891248BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
Siemens Hearing Instruments, Inc.
ESD
Mar 29, 1989K891011RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
Resound Corp.
ESD
Mar 29, 1989K884997ITE HEARING AID PARKER/TECHNITONE, MODEL PA
Hearing Enhancement Center, Inc.
ESD
Mar 17, 1989K890703CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
Oticon Corp.
ESD
Mar 9, 1989K890704BTE HEARING AID OTICON MODEL: E42P
Oticon Corp.
ESD
Mar 1, 1989K885128WIDEX BTE HEARING AID MODEL Q8
Widex Hearing Aid Co., Inc.
ESD
Feb 22, 1989K884871RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
Resound Corp.
ESD
Jan 18, 1989K884583BTE HEARING AID SIEMENS MODEL 284PP-ASP
Siemens Hearing Instruments, Inc.
ESD
Jan 13, 1989K882633ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
Ensoniq Corp.
ESD
Jan 3, 1989K884288HEARING AID, UNITRON BTE MODEL UM60-AGC0
Unitron Industries, Inc.
ESD
Dec 19, 1988K884113HEARING AID WIDEX BTE
Widex Hearing Aid Co., Inc.
ESD
Nov 14, 1988K883773H.A.C. MODEL-B (ALL IN THE CANAL)
Hearing Aid Crafters
ESD
Nov 14, 1988K883772H.A.C. MODEL-A (ALL IN THE EAR)
Hearing Aid Crafters
ESD
Oct 31, 1988K883961UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
Unimax Hearing Instruments
ESD
Sep 22, 1988K882678ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
Siemens Hearing Instruments, Inc.
ESD
Sep 15, 1988K882721ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
Hear-O Inc. C/O L.P. Leale & Assoc.
ESD
Sep 1, 1988K883513HEARING AID, UNITRON MODEL VISTA 1000
Unitron Industries, Inc.
ESD
Aug 30, 1988K882691MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
Maico Hearing Instruments, Inc.
ESD
Aug 26, 1988K882471ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
Ear Tech, Inc.
ESD

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