ETW · Class II · 21 CFR 874.3310

FDA Product Code ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

Leading manufacturers include Frye Electronics, Inc., Starkey Laboratories, Inc. and Madsen Electronics (Canada) , Ltd..

46
Total
46
Cleared
76d
Avg days
1980
Since
46 devices
25–46 of 46
Cleared Jan 22, 1990
TYPE FP40 DIGITAL HEARING AID ANALYZER
K895383
Frye Electronics, Inc.
Ear, Nose, Throat · 145d
Cleared Jan 16, 1990
MODEL 340 PROBE MIC SYSTEM
K896301
Virtual Corp.
Ear, Nose, Throat · 78d
Cleared Feb 13, 1989
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
K884046
Etymonic Design, Inc.
Ear, Nose, Throat · 140d
Cleared Feb 13, 1989
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Sep 16, 1987
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
K872633
Hearing Health Care Program
Ear, Nose, Throat · 72d
Cleared Jul 10, 1987
TYPE 6400 REAL EAR HEARING AID ANALYZER
K872242
Frye Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 16, 1987
AUDIOMETER
K870337
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Mar 13, 1987
HEARING AID TEST SYSTEM MODEL HAT 1000
K870229
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 51d
Cleared Aug 15, 1986
HA-2000 REAL EAR SPECTROSCOPE
K862026
And/Or Corp.
Ear, Nose, Throat · 79d
Cleared Jul 18, 1986
PHONIC EAR, MODEL PE 1800
K862162
Phonic Ear, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 16, 1986
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K862086
A/S Bruel & Kjaer
Ear, Nose, Throat · 44d
Cleared Jun 09, 1986
PHONIC EAR
K861857
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared May 30, 1986
TYPE 6500 HEARING AID ANALYZER
K861571
Frye Electronics, Inc.
Ear, Nose, Throat · 32d
Cleared Apr 23, 1986
ER-7C CLINICAL PROBE MICROPHONE
K861113
Etymotic Research
Ear, Nose, Throat · 29d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
HEARING AID ANALYSIS SYSTEM
K853271
Robert Bosch Corp.
Ear, Nose, Throat · 164d
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 03, 1982
STARKEY MODEL HAL-1
K821908
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d