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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
Jan 13, 1992K915875RIONET HEARING AID HB-71K (K-AMP)
Authorized Hearing Systems, Inc.
ESD
Jan 10, 1992K914897SONOTONE BEHIND THE EAR MODEL ST 54-0
Sonotone Intl., Inc.
ESD
Jan 9, 1992K915684REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
Rexton, Inc.
ESD
Jan 9, 1992K915683REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
Rexton, Inc.
ESD
Jan 9, 1992K915519SONOTONE BEHIND THE EAR MODEL ST 53A
Sonotone Intl., Inc.
ESD
Jan 9, 1992K915518SONOTONE BEHIND THE EAR MODEL ST 49
Sonotone Intl., Inc.
ESD
Jan 9, 1992K915517SONOTONE BODY AID MODEL ST 1000 BODY WORN
Sonotone Intl., Inc.
ESD
Jan 9, 1992K915319RIONET HEARING AID HB-52AS
Rion Co. Ltd. Dba Rion Acoustic Device
ESD
Jan 9, 1992K915076MED-EQUIP CORPORATION
Medequip Co.
ESD
Jan 9, 1992K914899SONOTONE BEHIND THE EAR MODEL ST 45G
Sonotone Hearing Instruments
ESD
Jan 9, 1992K914898SONOTONE BEHIND THE EAR MODEL ST 47I
Sonotone Hearing Instruments
ESD
Dec 30, 1991K915461PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
Phonak, Inc.
ESD
Dec 5, 1991K915252PHILIPS P74P BEHIND-THE-EAR HEARING AID
Philips Hearing Instruments Co.
ESD
Nov 27, 1991K914982BELTONE PROFILE IN-THE-EAR HEARING AID
Beltone Electronics Corp.
ESD
Nov 27, 1991K914981OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
Beltone Electronics Corp.
ESD
Nov 22, 1991K914940BELTONE CLEARVOICE
Beltone Electronics Corp.
ESD
Nov 22, 1991K914939OTOSONIC ACS-ASP
Beltone Electronics Corp.
ESD
Nov 5, 1991K914800P54 BTE HEARING AID
Philips Hearing Instruments Co.
ESD
Nov 5, 1991K914689HEARING AID, UNITRON MODEL VISTA 4000
Unitron Industries, Inc.
ESD
Nov 5, 1991K914688HEARING AID, UNITRON MODEL VISTA 3000
Unitron Industries, Inc.
ESD
Nov 5, 1991K913366IN-THE-EAR HEARING AIDS
Fenwick Hearing Instruments
ESD
Oct 21, 1991K914477AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
Oct 21, 1991K914418ACT-II BEHIND THE EAR HEARING AID
Telex Communications, Inc.
ESD
Oct 18, 1991K913245MODEL 80 HEARING AID DISPENSING SYSTEM
3M Company
ESD
Oct 11, 1991K914333SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
Siemens Hearing Instruments, Inc.
ESD
Sep 23, 1991K914017UC312, ULTRA MINIATURE ITC HEARING AID
Qualitone
ESD
Sep 18, 1991K913781QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
Qualitone
ESD
Sep 18, 1991K913771ELEGANCE - KED, BEHIND THE EAR HEARING AID
Qualitone
ESD
Sep 18, 1991K913592QUALITONE 46PP-AGC-I
Qualitone
ESD
Sep 6, 1991K913503PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
Phonak, Inc.
ESD
Sep 6, 1991K913502PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
Phonak, Inc.
ESD
Aug 26, 1991K913390M32 IN-THE-EAR HEARING AID
Philips Hearing Instruments Co.
ESD
Aug 26, 1991K913389PHILIPS S1594 OTB HEARING AID
Philips Hearing Instruments Co.
ESD
Jul 31, 1991K912870HEARING AID, UNITRON MODEL UIK
Unitron Industries, Inc.
ESD
Jul 24, 1991K912665SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
Resound Corp.
ESD
Jul 9, 1991K911183NHS 2044P BODY AID, HEARING AID
Magnatone Hearing Aid Corp.
ESD
Jun 26, 1991K912571PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
Phonak, Inc.
ESD
Jun 26, 1991K912570PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
Phonak, Inc.
ESD
Jun 26, 1991K911811SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
Siemens Hearing Instruments, Inc.
ESD
Jun 26, 1991K911810SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
Siemens Hearing Instruments, Inc.
ESD
Jun 20, 1991K912204TELEX MODEL TLP, IN-THE-EAR
Telex Communications, Inc.
ESD
Jun 17, 1991K912154QUALITONE MODEL 48 C-WR-BEHIND THE EAR
Qualitone
ESD
Jun 17, 1991K912153QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
Qualitone
ESD
Jun 7, 1991K912339PHILIPS M30 IN-THE-EAR HEARING AID
Philips Hearing Instruments Co.
ESD
May 28, 1991K912169WIDEX MODEL QX IN-THE-EAR HEARING AID
Widex Hearing Aid Co., Inc.
ESD
May 17, 1991K911709STOCK CANAL, IN-THE-EAR HEARING AID
Electone, Inc.
ESD
May 17, 1991K911708MODEL E-50, IN-THE-EAR HEARING AID
Electone, Inc.
ESD
May 17, 1991K911707REGAL, BEHIND-THE-EAR HEARING AID
Electone, Inc.
ESD
May 17, 1991K911706MODEL 800, BEHIND-THE-EAR HEARING AID
Electone, Inc.
ESD
May 17, 1991K911705CHAMPION, BEHIND-THE-EAR HEARING AID
Electone, Inc.
ESD

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