Product code EWO
- Device name
- Audiometer
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.1050
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024-06-21 |
| K240430 | Otoport Pro | Otodynamics, Ltd. | 2024-03-15 |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | 2023-10-27 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | 2022-06-22 |
| K191372 | Lyra | Interacoustics A/S | 2019-07-15 |
| K180287 | GSI Corti | Grason-Stadler, Inc. | 2018-05-11 |
| K173567 | Sera | Interacoustics A/S | 2018-02-14 |
| K172403 | GSI Novus | Grason-Stadler, Inc. | 2017-10-20 |
| K171506 | Easyscreen | Maico Diagnostics GmbH | 2017-08-29 |
| K151025 | iHearTest | Ihear Medical, Inc. | 2015-12-29 |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015-03-26 |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | 2015-03-12 |
| 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 |
| K133012 | SENTIERO | Path Medical GmbH | 2014-06-09 |
| K130795 | TITAN | Interacoustics A/S | 2013-06-20 |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | 2013-03-28 |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-11-01 |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-07-26 |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | 2012-04-20 |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | 2012-04-02 |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | Natus Medical Incorporated | 2011-12-28 |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2011-12-16 |
| K103298 | ACAM 5 AUDIOMETER SYSTEM | Acousticon GmbH | 2011-04-08 |
| K092089 | CLARUJUST | Audigence, Inc. | 2010-03-10 |
| K092244 | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS | Diagnostic Group, LLC | 2010-03-01 |
| K092111 | ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 | Entomed AB | 2009-10-02 |
| K090406 | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | Interacoustics AS | 2009-07-22 |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Gn Otometrics | 2008-07-14 |
| K072033 | OTODYNAMICS OTOPORT | Otodynamics, Ltd. | 2007-11-13 |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2007-06-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810046707180 | Grason-Stadler | Diagnostic Group LLC | 2026-04-06 |
| B43071000030 | GoCheck MultiScreener | Gobiquity, Inc. | 2025-11-19 |
| 25060753520070 | Tympa Mobile App | TYMPA HEALTH TECHNOLOGIES LIMITED | 2025-02-04 |
| 25060753520063 | Tympa Cloud | TYMPA HEALTH TECHNOLOGIES LIMITED | 2025-02-04 |
| 15060753520004 | Tympa Otoscope System | TYMPA HEALTH TECHNOLOGIES LIMITED | 2025-02-04 |
| B43071000020 | GoCheck MultiScreener | Gobiquity, Inc. | 2024-09-23 |
| 00817020021126 | Aria | INTELLIGENT HEARING SYSTEMS CORP. | 2024-03-11 |
| 00627908020192 | Bone Conductor | Vivosonic Inc | 2023-06-12 |
| 08054187380761 | TIMPANI DOCKING STATION | INVENTIS SRL | 2023-01-04 |
| 08054187380747 | TIMPANI | INVENTIS SRL | 2019-04-16 |
| 00810046700129 | Grason-Stadler | Diagnostic Group LLC | 2017-10-24 |
| 00382830008365 | Bio-logic | NATUS MEDICAL INCORPORATED | 2016-12-30 |
| 00382830046183 | ALGO Hearing Screening Supplies | NATUS MEDICAL INCORPORATED | 2016-12-30 |
| 08584270041458 | Grason-Stadler | Diagnostic Group LLC | 2016-11-10 |
| 08584270041076 | Grason-Stadler | Diagnostic Group LLC | 2016-11-10 |
| 00810046700051 | Grason-Stadler | Diagnostic Group LLC | 2016-11-10 |
| 00817020020822 | SmartScreener-Plus2 Screener Launch | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 00817020020754 | USBLite Cart Sound-Output-Electrode Box w 10D Grounded | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 00817020020716 | Screener Cart | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 00817020020129 | Smart USBLite | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 00817020020075 | USB Jr Duet | INTELLIGENT HEARING SYSTEMS CORP. | 2016-09-24 |
| 08054187380013 | BELL | INVENTIS SRL | 2016-09-17 |
| 08054187380341 | PICCOLO | INVENTIS SRL | 2016-09-17 |
| 08054187380358 | PICCOLO | INVENTIS SRL | 2016-09-17 |
| M737S55001 | Otogram | Ototronix, LLC | 2016-09-13 |
| M737S50001 | Otogram | Ototronix, LLC | 2016-09-13 |
| M737S3000R1 | Otogram | Ototronix, LLC | 2016-09-13 |
| M737ML40001 | Otogram | Ototronix, LLC | 2016-09-13 |
| M737G55001 | Otogram | Ototronix, LLC | 2016-09-13 |
| M737G50001 | Otogram | Ototronix, LLC | 2016-09-13 |