EWO · Class II · 21 CFR 874.1050

FDA Product Code EWO: Audiometer

Leading manufacturers include Maico Hearing Instruments, Inc., Bio-Logic Systems Corp. and Otodynamics, Ltd..

235
Total
235
Cleared
103d
Avg days
1976
Since
235 devices
25–48 of 235
Cleared Nov 13, 2007
OTODYNAMICS OTOPORT
K072033
Otodynamics, Ltd.
Ear, Nose, Throat · 112d
Cleared Jun 07, 2007
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K070880
Etymotic Research, Inc.
Ear, Nose, Throat · 69d
Cleared Mar 29, 2007
MA 55 MAESTRO
K063452
Maico Diagnostics (Diagnostic Group, LLC)
Ear, Nose, Throat · 134d
Cleared Mar 07, 2007
OTOGRAM, CA3350
K070118
Tympany, Inc.
Ear, Nose, Throat · 54d
Cleared Jan 04, 2007
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K063338
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 59d
Cleared Sep 15, 2006
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Jun 23, 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883
Interacoustics A/S
Ear, Nose, Throat · 84d
Cleared Jun 05, 2006
MODEL MI 44 TYMPANOMETER
K060885
Maico-Diagnostics
Ear, Nose, Throat · 66d
Cleared May 30, 2006
DPOAE20 , ECLIPSE
K060539
Interacoustics A/S, Assens
Ear, Nose, Throat · 90d
Cleared Feb 10, 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 23, 2005
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562
Interacoustics AS
Ear, Nose, Throat · 95d
Cleared Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219
Interacoustics AS
Ear, Nose, Throat · 74d
Cleared Jul 16, 2003
BIO-LOGIC INSERT EARPHONES
K031352
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801
Bio-Logic Systems Corp.
Ear, Nose, Throat · 24d
Cleared Feb 24, 2000
HORTMANN ECHOMASTER OAE ANALYZER
K994033
Hortmann AG
Ear, Nose, Throat · 90d
Cleared Mar 19, 1999
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Jan 29, 1999
AMPLAID A315 AND A319
K983915
Amplifon S.P.A.
Ear, Nose, Throat · 86d
Cleared Jan 28, 1999
CAPELLA COCHLEAR EMISSIONS ANALYZER
K983851
Madsen Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 12, 1999
AMPLAID A311 SERIES
K983712
Amplifon S.P.A.
Ear, Nose, Throat · 83d
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983350
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983351
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K983352
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Nov 17, 1998
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K983048
American Electromedics Corp.
Ear, Nose, Throat · 77d
Cleared Nov 03, 1998
EARSCAN 3
K982878
Micro Audiometrics Corp.
Ear, Nose, Throat · 81d