EWO · Class II · 21 CFR 874.1050

FDA Product Code EWO: Audiometer

Leading manufacturers include Maico Hearing Instruments, Inc., Bio-Logic Systems Corp. and Beltone Electronics Corp..

235
Total
235
Cleared
103d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Audiometer Devices (Product Code EWO)

235 devices
1–24 of 235
Cleared Jun 21, 2024
OtoNova/OtoNova Pro
K234095
Otodynamics
Ear, Nose, Throat · 178d
Cleared Mar 15, 2024
Otoport Pro
K240430
Otodynamics, Ltd.
Ear, Nose, Throat · 30d
Cleared Oct 27, 2023
hearOAE
K231545
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 150d
Cleared Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
K213345
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jul 15, 2019
Lyra
K191372
Interacoustics A/S
Ear, Nose, Throat · 54d
Cleared May 11, 2018
GSI Corti
K180287
Grason-Stadler, Inc.
Ear, Nose, Throat · 99d
Cleared Feb 14, 2018
Sera
K173567
Interacoustics A/S
Ear, Nose, Throat · 86d
Cleared Nov 01, 2012
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496
Bio-Logic Systems Corp.
Ear, Nose, Throat · 77d
Cleared Jul 26, 2012
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512
Bio-Logic Systems Corp.
Ear, Nose, Throat · 66d
Cleared Sep 15, 2006
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
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 Mar 19, 1999
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Jan 22, 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076
Bio-Logic Systems Corp.
Ear, Nose, Throat · 85d
Cleared May 13, 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132
Bio-Logic Systems Corp.
Ear, Nose, Throat · 210d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
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
PROPHET
K953884
Qualitone
Ear, Nose, Throat · 71d
Cleared Jul 12, 1995
BELTONE PERSONAL HEARING SCREENER
K943616
Beltone Electronics Corp.
Ear, Nose, Throat · 350d
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 09, 1994
ODYSSEY CLINICAL AUDIOMETER
K935348
Qualitone
Ear, Nose, Throat · 96d

About Product Code EWO - Regulatory Context

510(k) Submission Activity

235 total 510(k) submissions under product code EWO since 1976, with 235 receiving FDA clearance (average review time: 103 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.