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
73–96 of 235
Cleared Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995
Otodynamics, Ltd.
Ear, Nose, Throat · 162d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 08, 1996
CCA-100 (MODIFIED)
K963681
Benson Medical Instruments Co.
Ear, Nose, Throat · 89d
Cleared Sep 05, 1996
MAICO MA25 SERIES II WITH SPEECH
K962275
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 21, 1996
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
K962012
Ethical Hearing Instruments
Ear, Nose, Throat · 90d
Cleared May 29, 1996
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447
Bio-Logic Systems Corp.
Ear, Nose, Throat · 43d
Cleared Oct 27, 1995
GSI 61 CLINICAL AUDIOMETER
K953684
Grason-Stadler, Inc.
Ear, Nose, Throat · 85d
Cleared Oct 27, 1995
PROPHET
K953884
Qualitone
Ear, Nose, Throat · 71d
Cleared Jul 12, 1995
BELTONE PERSONAL HEARING SCREENER
K943616
Beltone Electronics Corp.
Ear, Nose, Throat · 350d
Cleared Jul 06, 1995
GSI 65 COMPUTERIZED AUDIOMETER
K951759
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared May 03, 1995
THE PILOT AUDIOMETER
K951527
American Electromedics Corp.
Ear, Nose, Throat · 30d
Cleared Dec 21, 1994
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Sep 02, 1994
AUDIO EXPERT AUDIOMETER
K942716
Beltone Electronics Corp.
Ear, Nose, Throat · 85d
Cleared Aug 19, 1994
KS 5 - CLINICAL AUDIOMETER
K931322
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 521d
Cleared Jul 29, 1994
BELTONE SERIES 100 AUDIOMETERS
K940216
Beltone Electronics Corp.
Ear, Nose, Throat · 196d
Cleared Feb 18, 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 339d
Cleared Feb 09, 1994
ODYSSEY CLINICAL AUDIOMETER
K935348
Qualitone
Ear, Nose, Throat · 96d
Cleared Nov 24, 1993
SELECTOR SL 01
K933220
Futuremed Div. of Future Impex Corp.
Ear, Nose, Throat · 146d
Cleared Nov 19, 1993
ORBITER 922 CLINICAL AUDIOMETER
K931324
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 248d
Cleared Nov 01, 1993
AUDIOMETER DA 323
K933222
Futuremed Div. of Future Impex Corp.
Ear, Nose, Throat · 123d
Cleared Aug 05, 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 225d
Cleared Aug 05, 1993
MAICO MA790 AUDIOMETER
K930112
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 206d
Cleared Feb 26, 1993
AT-2
K923007
Qualitone
Ear, Nose, Throat · 249d
Cleared Nov 05, 1992
ST 20 PORTABLE AUDIOMETER
K922746
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 150d