FDA Product Code
FDA Product Code EWO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.1050
510(k) Clearances — 235 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024-06-21 | Traditional | PDF ↗ |
| K240430 | Otoport Pro | Otodynamics, Ltd. | 2024-03-15 | Special | PDF ↗ |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | 2023-10-27 | Traditional | PDF ↗ |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | 2022-06-22 | Traditional | PDF ↗ |
| K191372 | Lyra | Interacoustics A/S | 2019-07-15 | Traditional | PDF ↗ |
| K180287 | GSI Corti | Grason-Stadler, Inc. | 2018-05-11 | Traditional | PDF ↗ |
| K173567 | Sera | Interacoustics A/S | 2018-02-14 | Traditional | PDF ↗ |
| K172403 | GSI Novus | Grason-Stadler, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K171506 | Easyscreen | Maico Diagnostics GmbH | 2017-08-29 | Traditional | PDF ↗ |
| K151025 | iHearTest | Ihear Medical, Inc. | 2015-12-29 | Traditional | PDF ↗ |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015-03-26 | Special | PDF ↗ |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | 2015-03-12 | Traditional | PDF ↗ |
| K143395 | 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 | Otodynamics, Ltd. | 2015-02-23 | Traditional | PDF ↗ |
| K133012 | SENTIERO | Path Medical GmbH | 2014-06-09 | Traditional | PDF ↗ |
| K130795 | TITAN | Interacoustics A/S | 2013-06-20 | Traditional | PDF ↗ |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | 2013-03-28 | Special | PDF ↗ |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-11-01 | Traditional | PDF ↗ |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-07-26 | Traditional | PDF ↗ |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | 2012-04-20 | Traditional | PDF ↗ |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | 2012-04-02 | Traditional | PDF ↗ |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | Natus Medical Incorporated | 2011-12-28 | Traditional | PDF ↗ |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K103298 | ACAM 5 AUDIOMETER SYSTEM | Acousticon GmbH | 2011-04-08 | Traditional | PDF ↗ |
| K092089 | CLARUJUST | Audigence, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K092244 | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS | Diagnostic Group, LLC | 2010-03-01 | Traditional | PDF ↗ |
| K092111 | ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 | Entomed AB | 2009-10-02 | Traditional | PDF ↗ |
| K090406 | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | Interacoustics AS | 2009-07-22 | Traditional | PDF ↗ |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Gn Otometrics | 2008-07-14 | Traditional | PDF ↗ |
| K072033 | OTODYNAMICS OTOPORT | Otodynamics, Ltd. | 2007-11-13 | Traditional | PDF ↗ |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K063452 | MA 55 MAESTRO | Maico Diagnostics (Diagnostic Group, LLC) | 2007-03-29 | Traditional | PDF ↗ |
| K070118 | OTOGRAM, CA3350 | Tympany, Inc. | 2007-03-07 | Traditional | PDF ↗ |
| K063338 | HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER | Mimosa Acoustics, Inc. | 2007-01-04 | Traditional | PDF ↗ |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | Bio-Logic Systems Corp. | 2006-09-15 | Traditional | PDF ↗ |
| K060883 | PILOT TEST OR DETECTIVE AUDIOMETERS | Interacoustics A/S | 2006-06-23 | Traditional | PDF ↗ |
| K060885 | MODEL MI 44 TYMPANOMETER | Maico-Diagnostics | 2006-06-05 | Traditional | PDF ↗ |
| K060539 | DPOAE20 , ECLIPSE | Interacoustics A/S, Assens | 2006-05-30 | Traditional | PDF ↗ |
| K053216 | HEARID WIDEBAND MIDDLE EAR POWER ANALYZER | Mimosa Acoustics, Inc. | 2006-02-10 | Traditional | PDF ↗ |
| K052562 | ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. | Interacoustics AS | 2005-12-23 | Traditional | PDF ↗ |
| K043219 | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS | Interacoustics AS | 2005-02-04 | Traditional | PDF ↗ |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | Vivosonic, Inc. | 2003-10-27 | Special | PDF ↗ |
| K031713 | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS | Viasys Healthcare, Inc. | 2003-08-12 | Traditional | PDF ↗ |
| K031986 | ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS | Ics Medical | 2003-07-24 | Special | PDF ↗ |
| K031352 | BIO-LOGIC INSERT EARPHONES | Bio-Logic Systems Corp. | 2003-07-16 | Traditional | PDF ↗ |
| K030016 | TEOAE25 | Interacoustics A/S, Assens | 2003-03-28 | Traditional | PDF ↗ |
| K024205 | AUDIOSCREENER OAE+ABR | Everest Biomedical Instruments Co. | 2003-03-07 | Traditional | PDF ↗ |
| K023859 | SMARTTROAE | Intelligent Hearing Systems | 2003-01-08 | Traditional | PDF ↗ |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | Bio-Logic Systems Corp. | 2002-06-27 | Special | PDF ↗ |
| K011135 | GSI AUDERA | Nicolet Biomedical | 2001-07-26 | Traditional | PDF ↗ |
| K003364 | VIVO 200 DPS VIVOSCAN | Vivosonic, Inc. | 2001-07-18 | Traditional | PDF ↗ |
| K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | Etymotic Research | 2001-07-03 | Traditional | PDF ↗ |
| K011181 | ICS MEDICAL CHARTR OAE WITH TYMP | Ics Medical Corp. | 2001-06-25 | Traditional | PDF ↗ |
| K003913 | HINT AUDIOMETER, OR HINT | Maico-Diagnostics | 2001-03-16 | Traditional | PDF ↗ |
| K010165 | ERO SCAN OAE TEST SYSTEM | Etymotic Research | 2001-03-12 | Traditional | PDF ↗ |
| K002200 | CAPELLA | Madsen Electronics, Inc. | 2000-08-25 | Traditional | PDF ↗ |
| K001058 | AUDIOSCREENER OAE + ABR | Kedly, Inc. | 2000-06-02 | Traditional | PDF ↗ |
| K994033 | HORTMANN ECHOMASTER OAE ANALYZER | Hortmann AG | 2000-02-24 | Traditional | PDF ↗ |
| K000184 | AUDIOSCREENER OAE | Kedly, Inc. | 2000-02-11 | Traditional | PDF ↗ |
| K984547 | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS | Resound Corp. | 1999-03-19 | Traditional | PDF ↗ |
| K983915 | AMPLAID A315 AND A319 | Amplifon S.P.A. | 1999-01-29 | Traditional | PDF ↗ |
| K983851 | CAPELLA COCHLEAR EMISSIONS ANALYZER | Madsen Electronics, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K983712 | AMPLAID A311 SERIES | Amplifon S.P.A. | 1999-01-12 | Traditional | PDF ↗ |
| K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | Otodynamics, Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | American Electromedics Corp. | 1998-11-17 | Traditional | PDF ↗ |
| K982878 | EARSCAN 3 | Micro Audiometrics Corp. | 1998-11-03 | Traditional | PDF ↗ |
| K982723 | MAICO MA42 | Bernafon-Maico, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K982566 | AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) | Bar - Advanced Control Systems , Ltd. | 1998-10-21 | Traditional | PDF ↗ |
| K982642 | ECHO-SCREEN | Fischer-Zoth Audiologic Systems, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K982441 | CCA-220 | Benson Medical Instruments Co. | 1998-10-09 | Traditional | PDF ↗ |
| K982249 | INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1998-08-07 | Traditional | PDF ↗ |
| K981511 | OTO WIZZARD | Medrx, Inc. | 1998-07-24 | Traditional | PDF ↗ |
| K981439 | CCA-200 | Benson Medical Instruments Co. | 1998-06-15 | Traditional | PDF ↗ |
| K981460 | CUB DIS II DPOAE MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K981327 | INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1998-05-11 | Traditional | PDF ↗ |
| K981142 | MAICO MA53 | Bernafon-Maico, Inc. | 1998-04-22 | Traditional | PDF ↗ |
| K980505 | HORTMANN AMDIS-OAE OAE ANALYZER | Hortmann AG | 1998-04-07 | Traditional | PDF ↗ |
| K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | Etymotic Research | 1998-03-23 | Traditional | PDF ↗ |
| K973377 | SIBELMED AC50D | Trutone | 1998-03-10 | Traditional | PDF ↗ |
| K974237 | GSI 70 AUDIOPATH SCREENER | Grason-Stadler, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K974076 | SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE | Bio-Logic Systems Corp. | 1998-01-22 | Traditional | PDF ↗ |
| K973320 | ARTICULATE FITTING SYSTEM | Decibel Instruments, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K972862 | AMPLAID 171S | Amplifon S.P.A. | 1997-10-31 | Traditional | PDF ↗ |
| K972221 | K 15 AUDIOMETER | American Electromedics Corp. | 1997-09-08 | Traditional | PDF ↗ |
| K971747 | AMPLAID 460 | Amplifon S.P.A. | 1997-08-05 | Traditional | PDF ↗ |
| K971080 | MAICO MA52 | Bernafon-Maico, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K964132 | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT | Bio-Logic Systems Corp. | 1997-05-13 | Traditional | PDF ↗ |
| K970279 | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | American Electromedics Corp. | 1997-03-18 | Traditional | PDF ↗ |
| K970555 | IL0292 DP ECHOPORT | Smith | 1997-03-17 | Traditional | PDF ↗ |
| K964426 | SMARTOAE | Intelligent Hearing Systems | 1997-02-03 | Traditional | PDF ↗ |
| K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | Otodynamics, Ltd. | 1997-01-10 | Traditional | PDF ↗ |
| K964340 | PORTAREM-3000, PFS-6000 | Starkey Laboratories, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K963681 | CCA-100 (MODIFIED) | Benson Medical Instruments Co. | 1996-10-08 | Traditional | PDF ↗ |
| K962275 | MAICO MA25 SERIES II WITH SPEECH | Bernafon-Maico, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K962012 | ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER | Ethical Hearing Instruments | 1996-08-21 | Traditional | PDF ↗ |
| K961447 | SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT | Bio-Logic Systems Corp. | 1996-05-29 | Traditional | PDF ↗ |
| K953814 | OTOSCAPE | Soundscape Technologies, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K953884 | PROPHET | Qualitone | 1995-10-27 | Traditional | PDF ↗ |
| K953684 | GSI 61 CLINICAL AUDIOMETER | Grason-Stadler, Inc. | 1995-10-27 | Traditional | PDF ↗ |
Product code EWO · Class II · Ear, Nose, Throat. Data: openFDA.