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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
Nov 27, 1996K964508UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
Unitron Industries, Inc.
ESD
Nov 27, 1996K964504UNITRON MODEL ICON AOHPL +4
Unitron Industries, Inc.
ESD
Nov 27, 1996K964503UNITRON MODEL SOUND F/X +4
Unitron Industries, Inc.
ESD
Nov 27, 1996K964502UNITRON MODEL SOUND F/XP +4
Unitron Industries, Inc.
ESD
Nov 27, 1996K964451PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
Rexton, Inc.
ESD
Nov 27, 1996K964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
Starkey Laboratories, Inc.
ESD
Nov 27, 1996K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
Starkey Laboratories, Inc.
ESD
Nov 27, 1996K963875AHS OMEGA K-AMP
Authorized Hearing Systems, Inc.
ESD
Nov 27, 1996K963788PRIMOFOCUS COMPACT
Oticon Corp.
ESD
Nov 26, 1996K964180AUDIO 'D' SOUND SELECTOR POWER (SSP)
Hearing Solutions, Inc.
ESD
Nov 26, 1996K963881AHS DELTA 22 T
Authorized Hearing Systems, Inc.
ESD
Nov 26, 1996K963879AHS DELTA 22
Authorized Hearing Systems, Inc.
ESD
Nov 26, 1996K963876AHS OMEGA PP
Authorized Hearing Systems, Inc.
ESD
Nov 26, 1996K963874AHS OMEGA AGC
Authorized Hearing Systems, Inc.
ESD
Nov 26, 1996K963873AHS OMEGA DEQ
Authorized Hearing Systems, Inc.
ESD
Nov 26, 1996K963745MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
Hearing Innovations, Inc.
ESD
Nov 8, 1996K963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
Telex Communications, Inc.
ESD
Nov 4, 1996K964115RESOUND CC4 PERSONAL HEARING SYSTEM
Resound Corp.
ESD
Oct 28, 1996K963822OVATION AGC-3
Orsonique, Inc., CA
ESD
Oct 28, 1996K963821OVATION AGC-1
Orsonique, Inc., CA
ESD
Oct 28, 1996K963820OVATION LINEAR
Orsonique, Inc., CA
ESD
Oct 28, 1996K963819OVATION ASP
Orsonique, Inc., CA
ESD
Oct 28, 1996K963818OVATION AGC-2
Orsonique, Inc., CA
ESD
Sep 27, 1996K963604DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
Midwest City Hearing Aid Center
ESD
Sep 27, 1996K963519EUROLINE A-675 SERIS
Starkey Laboratories, Inc.
ESD
Sep 20, 1996K963607HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
Midwest City Hearing Aid Center
ESD
Sep 16, 1996K962388IN THE EAR HEARING AID
Unique Hearing Technology, Inc.
ESD
Sep 10, 1996K963047AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
Fenwick Hearing Instruments
ESD
Sep 9, 1996K962798AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
Hearing Solutions, Inc.
ESD
Sep 6, 1996K963122UNITRON MODEL ICON KR
Unitron Industries, Inc.
ESD
Sep 5, 1996K963154RIONET HB-54AS
Authorized Hearing Systems, Inc.
ESD
Sep 5, 1996K963153RIONET HB-55S
Authorized Hearing Systems, Inc.
ESD
Sep 5, 1996K963152RIONET HB-55AS
Authorized Hearing Systems, Inc.
ESD
Aug 28, 1996K962228MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
Ototech Intl., Inc.
ESD
Aug 9, 1996K962847MT10P, MT60-PP, MT60-AGC0, AND MT60
Micro-Tech Hearing Instruments
ESD
Aug 2, 1996K961770PHILIPS 71 SERIES
Philips Hearing Instruments Co.
ESD
Jul 25, 1996K962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
Siemens Hearing Instruments, Inc.
ESD
Jul 3, 1996K961907RIONET HEARING AID HB53-K
Authorized Hearing Systems, Inc.
ESD
Jul 3, 1996K961827IN-THE-EAR
Qualitone
ESD
May 29, 1996K961729ARGOSY PROGRAMMABLE
Argosy Electronics
ESD
May 29, 1996K961653PHONAK SONA P2
Phonak, Inc.
ESD
May 17, 1996K961622PHONAK PICONET2 P2 AZ
Phonak, Inc.
ESD
May 14, 1996K961670CLARITY
Seig Technologies, Inc.
ESD
May 7, 1996K961308AUDIO 'D' INTIMA CIC
Hearing Solutions, Inc.
ESD
May 7, 1996K961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
Telex Communications, Inc.
ESD
May 7, 1996K961082TECHNA TONE
Techna Tone
ESD
May 7, 1996K961059DIGIFOCUS COMPACT
Oticon, Inc.
ESD
May 7, 1996K960741COMFORTONE PHS
Comfortone America'S Value Hearing Aid Line
ESD
Apr 18, 1996K961084AM 400
Electone, Inc.
ESD
Apr 10, 1996K960684HEARING AID - AIR CONDUCTION
Resound Corp.
ESD

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