Audiometer
FDA product code EWO · 230 cleared devices
Class 2
Ear, Nose, Throat
- Regulation
- 21 CFR 874.1050
- Review panel
- EN
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-10-29 – 2024-06-21
EWO
2024-06-21
EWO
2024-03-15
Otoport Pro
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EWO
2023-10-27
hearOAE
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EWO
2022-06-22
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
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EWO
2019-07-15
Lyra
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EWO
2018-05-11
GSI Corti
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EWO
2018-02-14
Sera
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EWO
2017-10-20
GSI Novus
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EWO
2017-08-29
Easyscreen
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EWO
2013-06-20
TITAN
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EWO
2013-03-28
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
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EWO
2012-11-01
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
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EWO
2012-07-26
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
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EWO
2012-04-20
EARLOGIC OAE TESTER
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EWO
2012-04-02
A BAER WITH ABAER I/O FUNCTION
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EWO
2011-12-28
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
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EWO
2011-12-16
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
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EWO
2011-04-08
ACAM 5 AUDIOMETER SYSTEM
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EWO
2010-03-10
CLARUJUST
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EWO
2010-03-01
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
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EWO
2009-10-02
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
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EWO
2009-07-22
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
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EWO
2008-07-14
GN OTOMETRICS INSERT EARPHONES
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EWO
2007-11-13
OTODYNAMICS OTOPORT
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EWO
2007-06-07
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
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EWO
2007-03-29
MA 55 MAESTRO
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EWO
2007-03-07
OTOGRAM, CA3350
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EWO
2007-01-04
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
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EWO
2006-09-15
COCHLEA-SCAN / COCHLEA-SCAN PLUS
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EWO
2006-06-23
PILOT TEST OR DETECTIVE AUDIOMETERS
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EWO
2006-06-05
MODEL MI 44 TYMPANOMETER
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EWO
2006-05-30
DPOAE20 , ECLIPSE
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EWO
2006-02-10
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
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EWO
2005-12-23
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
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EWO
2005-02-04
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
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EWO
2003-10-27
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
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EWO
2003-08-12
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
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EWO
2003-07-24
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
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EWO
2003-07-16
BIO-LOGIC INSERT EARPHONES
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EWO
2003-03-28
TEOAE25
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EWO
2003-03-07
AUDIOSCREENER OAE+ABR
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EWO
2003-01-08
SMARTTROAE
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EWO
2002-06-27
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
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EWO
2001-07-26
GSI AUDERA
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EWO
2001-07-18
VIVO 200 DPS VIVOSCAN
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EWO
2001-07-03
ETYMOTIC RESEARCH ER-10D OAE PROBE
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EWO
2001-06-25
ICS MEDICAL CHARTR OAE WITH TYMP
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EWO
2001-03-16
HINT AUDIOMETER, OR HINT
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EWO
2001-03-12
ERO SCAN OAE TEST SYSTEM
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EWO
2000-08-25
CAPELLA
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EWO
2000-06-02
AUDIOSCREENER OAE + ABR
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EWO
2000-02-24
HORTMANN ECHOMASTER OAE ANALYZER
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EWO
2000-02-11
AUDIOSCREENER OAE
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EWO
1999-03-19
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
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EWO
1999-01-29
AMPLAID A315 AND A319
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EWO
1999-01-28
CAPELLA COCHLEAR EMISSIONS ANALYZER
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EWO
1999-01-12
AMPLAID A311 SERIES
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EWO
1998-12-11
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
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EWO
1998-12-11
ILO292 DP ECHOPORT PLUS OAE SYSTEM
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EWO
1998-12-11
ILO292 DP ECHOPORT PLUS OAE SYSTEM
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EWO
1998-11-17
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
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EWO
1998-11-03
EARSCAN 3
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EWO
1998-10-28
MAICO MA42
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EWO
1998-10-21
ECHO-SCREEN
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EWO
1998-10-21
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
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EWO
1998-10-09
CCA-220
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EWO
1998-08-07
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
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EWO
1998-07-24
OTO WIZZARD
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EWO
1998-06-15
CCA-200
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EWO
1998-05-20
CUB DIS II DPOAE MEASUREMENT SYSTEM
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EWO
1998-05-11
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
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EWO
1998-04-22
MAICO MA53
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EWO
1998-04-07
HORTMANN AMDIS-OAE OAE ANALYZER
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EWO
1998-03-23
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
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EWO
1998-03-10
SIBELMED AC50D
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EWO
1998-02-10
GSI 70 AUDIOPATH SCREENER
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EWO
1998-01-22
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
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EWO
1997-11-25
ARTICULATE FITTING SYSTEM
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EWO
1997-10-31
AMPLAID 171S
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EWO
1997-09-08
K 15 AUDIOMETER
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EWO
1997-08-05
AMPLAID 460
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EWO
1997-06-06
MAICO MA52
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EWO
1997-05-13
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
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EWO
1997-03-18
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
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EWO
1997-03-17
IL0292 DP ECHOPORT
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EWO
1997-02-03
SMARTOAE
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EWO
1997-01-10
PORTAREM-3000, PFS-6000
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EWO
1997-01-10
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
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EWO
1996-10-08
CCA-100 (MODIFIED)
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EWO
1996-09-05
MAICO MA25 SERIES II WITH SPEECH
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EWO
1996-08-21
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
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EWO
1996-05-29
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
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EWO
1995-12-21
OTOSCAPE
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EWO
1995-10-27
PROPHET
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EWO
1995-10-27
GSI 61 CLINICAL AUDIOMETER
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EWO
1995-07-12
BELTONE PERSONAL HEARING SCREENER
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EWO
1995-07-06
GSI 65 COMPUTERIZED AUDIOMETER
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EWO
1995-05-12
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
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EWO
1995-05-03
THE PILOT AUDIOMETER
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EWO
1995-04-11
RH2000 REAL EAR MEASUREMENT SYSTEM
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