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
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 Oct 20, 2017
GSI Novus
K172403
Grason-Stadler, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 29, 2017
Easyscreen
K171506
Maico Diagnostics GmbH
Ear, Nose, Throat · 98d
Cleared Dec 29, 2015
iHearTest
K151025
Ihear Medical, Inc.
Ear, Nose, Throat · 257d
Cleared Mar 26, 2015
ER36 Series OAE Test System
K150491
Etymotic Research, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 12, 2015
NEURO-AUDIO
K141524
Teleemg, LLC USA
Ear, Nose, Throat · 276d
Cleared Feb 23, 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
K143395
Otodynamics, Ltd.
Ear, Nose, Throat · 89d
Cleared Jun 09, 2014
SENTIERO
K133012
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 20, 2013
TITAN
K130795
Interacoustics A/S
Ear, Nose, Throat · 90d
Cleared Mar 28, 2013
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
K123624
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 125d
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 Apr 20, 2012
EARLOGIC OAE TESTER
K112992
Earlogic Corporation
Ear, Nose, Throat · 197d
Cleared Apr 02, 2012
A BAER WITH ABAER I/O FUNCTION
K112247
Natus Medical Incorporated
Ear, Nose, Throat · 242d
Cleared Dec 28, 2011
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
K111618
Natus Medical Incorporated
Ear, Nose, Throat · 201d
Cleared Dec 16, 2011
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K112733
Etymotic Research, Inc.
Ear, Nose, Throat · 87d
Cleared Apr 08, 2011
ACAM 5 AUDIOMETER SYSTEM
K103298
Acousticon GmbH
Ear, Nose, Throat · 151d
Cleared Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
K081234
Gn Otometrics
Ear, Nose, Throat · 74d

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.