Atlas FDA

EWO

235 FDA 510(k) clearances · Product code

85 daysmedian time to decision
216 days90th percentile
235clearances measured

FDA profile

Official device name
Audiometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1998: 1 · 2006: 3 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OtoNova/OtoNova Pro (K234095)Otodynamics2024-06-21
Otoport Pro (K240430)Otodynamics, Ltd.2024-03-15
hearOAE (K231545)Hearx SA (Pty) , Ltd.2023-10-27
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (K213345)Path Medical GmbH2022-06-22
Lyra (K191372)Interacoustics A/S2019-07-15
GSI Corti (K180287)Grason-Stadler, Inc.2018-05-11
Sera (K173567)Interacoustics A/S2018-02-14
GSI Novus (K172403)Grason-Stadler, Inc.2017-10-20
Easyscreen (K171506)Maico Diagnostics GmbH2017-08-29
iHearTest (K151025)Ihear Medical, Inc.2015-12-29
ER36 Series OAE Test System (K150491)Etymotic Research, Inc.2015-03-26
NEURO-AUDIO (K141524)Teleemg, LLC USA2015-03-12
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.2015-02-23
SENTIERO (K133012)Path Medical GmbH2014-06-09
TITAN (K130795)Interacoustics A/S2013-06-20
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM (K123624)Mimosa Acoustics, Inc.2013-03-28
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K122496)Bio-Logic Systems Corp.2012-11-01
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K121512)Bio-Logic Systems Corp.2012-07-26
EARLOGIC OAE TESTER (K112992)Earlogic Corporation2012-04-20
A BAER WITH ABAER I/O FUNCTION (K112247)Natus Medical Incorporated2012-04-02
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION (K111618)Natus Medical Incorporated2011-12-28
ER35 ERO-SCAN PRO HEARING TEST SYSTEM (K112733)Etymotic Research, Inc.2011-12-16
ACAM 5 AUDIOMETER SYSTEM (K103298)Acousticon GmbH2011-04-08
CLARUJUST (K092089)Audigence, Inc.2010-03-10
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS (K092244)Diagnostic Group, LLC2010-03-01
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 (K092111)Entomed AB2009-10-02
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE (K090406)Interacoustics AS2009-07-22
GN OTOMETRICS INSERT EARPHONES (K081234)Gn Otometrics2008-07-14
OTODYNAMICS OTOPORT (K072033)Otodynamics, Ltd.2007-11-13
ER35 ERO-SCAN PRO HEARING TEST SYSTEM (K070880)Etymotic Research, Inc.2007-06-07
MA 55 MAESTRO (K063452)Maico Diagnostics (Diagnostic Group, LLC)2007-03-29
OTOGRAM, CA3350 (K070118)Tympany, Inc.2007-03-07
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER (K063338)Mimosa Acoustics, Inc.2007-01-04
COCHLEA-SCAN / COCHLEA-SCAN PLUS (K061744)Bio-Logic Systems Corp.2006-09-15
PILOT TEST OR DETECTIVE AUDIOMETERS (K060883)Interacoustics A/S2006-06-23
MODEL MI 44 TYMPANOMETER (K060885)Maico-Diagnostics2006-06-05
DPOAE20 , ECLIPSE (K060539)Interacoustics A/S, Assens2006-05-30
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (K053216)Mimosa Acoustics, Inc.2006-02-10
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. (K052562)Interacoustics AS2005-12-23
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS (K043219)Interacoustics AS2005-02-04
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER (K033108)Vivosonic, Inc.2003-10-27
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS (K031713)Viasys Healthcare, Inc.2003-08-12
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (K031986)Ics Medical2003-07-24
BIO-LOGIC INSERT EARPHONES (K031352)Bio-Logic Systems Corp.2003-07-16
TEOAE25 (K030016)Interacoustics A/S, Assens2003-03-28
AUDIOSCREENER OAE+ABR (K024205)Everest Biomedical Instruments Co.2003-03-07
SMARTTROAE (K023859)Intelligent Hearing Systems2003-01-08
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (K021801)Bio-Logic Systems Corp.2002-06-27
GSI AUDERA (K011135)Nicolet Biomedical2001-07-26
VIVO 200 DPS VIVOSCAN (K003364)Vivosonic, Inc.2001-07-18
ETYMOTIC RESEARCH ER-10D OAE PROBE (K011114)Etymotic Research2001-07-03
ICS MEDICAL CHARTR OAE WITH TYMP (K011181)Ics Medical Corp.2001-06-25
HINT AUDIOMETER, OR HINT (K003913)Maico-Diagnostics2001-03-16
ERO SCAN OAE TEST SYSTEM (K010165)Etymotic Research2001-03-12
CAPELLA (K002200)Madsen Electronics, Inc.2000-08-25
AUDIOSCREENER OAE + ABR (K001058)Kedly, Inc.2000-06-02
HORTMANN ECHOMASTER OAE ANALYZER (K994033)Hortmann AG2000-02-24
AUDIOSCREENER OAE (K000184)Kedly, Inc.2000-02-11
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS (K984547)Resound Corp.1999-03-19
AMPLAID A315 AND A319 (K983915)Amplifon S.P.A.1999-01-29
CAPELLA COCHLEAR EMISSIONS ANALYZER (K983851)Madsen Electronics, Inc.1999-01-28
AMPLAID A311 SERIES (K983712)Amplifon S.P.A.1999-01-12
ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983351)Otodynamics, Ltd.1998-12-11
ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983350)Otodynamics, Ltd.1998-12-11
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK (K983352)Otodynamics, Ltd.1998-12-11
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983048)American Electromedics Corp.1998-11-17
EARSCAN 3 (K982878)Micro Audiometrics Corp.1998-11-03
MAICO MA42 (K982723)Bernafon-Maico, Inc.1998-10-28
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) (K982566)Bar - Advanced Control Systems , Ltd.1998-10-21
ECHO-SCREEN (K982642)Fischer-Zoth Audiologic Systems, Inc.1998-10-21
CCA-220 (K982441)Benson Medical Instruments Co.1998-10-09
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER (K982249)Idem (Int'L Dist. of Electronics For Medicine)1998-08-07
OTO WIZZARD (K981511)Medrx, Inc.1998-07-24
CCA-200 (K981439)Benson Medical Instruments Co.1998-06-15
CUB DIS II DPOAE MEASUREMENT SYSTEM (K981460)Mimosa Acoustics, Inc.1998-05-20
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER (K981327)Idem (Int'L Dist. of Electronics For Medicine)1998-05-11
MAICO MA53 (K981142)Bernafon-Maico, Inc.1998-04-22
HORTMANN AMDIS-OAE OAE ANALYZER (K980505)Hortmann AG1998-04-07
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) (K980533)Etymotic Research1998-03-23
SIBELMED AC50D (K973377)Trutone1998-03-10
GSI 70 AUDIOPATH SCREENER (K974237)Grason-Stadler, Inc.1998-02-10
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE (K974076)Bio-Logic Systems Corp.1998-01-22
ARTICULATE FITTING SYSTEM (K973320)Decibel Instruments, Inc.1997-11-25
AMPLAID 171S (K972862)Amplifon S.P.A.1997-10-31
K 15 AUDIOMETER (K972221)American Electromedics Corp.1997-09-08
AMPLAID 460 (K971747)Amplifon S.P.A.1997-08-05
MAICO MA52 (K971080)Bernafon-Maico, Inc.1997-06-06
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT (K964132)Bio-Logic Systems Corp.1997-05-13
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) (K970279)American Electromedics Corp.1997-03-18
IL0292 DP ECHOPORT (K970555)Smith1997-03-17
SMARTOAE (K964426)Intelligent Hearing Systems1997-02-03
PORTAREM-3000, PFS-6000 (K964340)Starkey Laboratories, Inc.1997-01-10
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC (K962995)Otodynamics, Ltd.1997-01-10
CCA-100 (MODIFIED) (K963681)Benson Medical Instruments Co.1996-10-08
MAICO MA25 SERIES II WITH SPEECH (K962275)Bernafon-Maico, Inc.1996-09-05
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER (K962012)Ethical Hearing Instruments1996-08-21
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT (K961447)Bio-Logic Systems Corp.1996-05-29
OTOSCAPE (K953814)Soundscape Technologies, Inc.1995-12-21
PROPHET (K953884)Qualitone1995-10-27
GSI 61 CLINICAL AUDIOMETER (K953684)Grason-Stadler, Inc.1995-10-27
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