EWO · Audiometer
Ear, Nose, Throat · 21 CFR 874.1050 · Class 2
Overview
| Product Code | EWO |
|---|---|
| Device Name | Audiometer |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Classification Rationale
Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 235)
Showing 20 most recent of 235 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | Jun 21, 2024 | SESE |
| K240430 | Otoport Pro | Otodynamics, Ltd. | Mar 15, 2024 | SESE |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | Oct 27, 2023 | SESE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | Jun 22, 2022 | SESE |
| K191372 | Lyra | Interacoustics A/S | Jul 15, 2019 | SESE |
| K180287 | GSI Corti | Grason-Stadler, Inc. | May 11, 2018 | SESE |
| K173567 | Sera | Interacoustics A/S | Feb 14, 2018 | SESE |
| K172403 | GSI Novus | Grason-Stadler, Inc. | Oct 20, 2017 | SESE |
| K171506 | Easyscreen | Maico Diagnostics GmbH | Aug 29, 2017 | SESE |
| K151025 | iHearTest | Ihear Medical, Inc. | Dec 29, 2015 | SESE |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | Mar 26, 2015 | SESE |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | Mar 12, 2015 | SESE |
| 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. | Feb 23, 2015 | SESE |
| K133012 | SENTIERO | Path Medical GmbH | Jun 9, 2014 | SESE |
| K130795 | TITAN | Interacoustics A/S | Jun 20, 2013 | SESE |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | Mar 28, 2013 | SESE |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Nov 1, 2012 | SESE |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Jul 26, 2012 | SESE |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | Apr 20, 2012 | SESE |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | Apr 2, 2012 | SESE |
Top Applicants
- Maico Hearing Instruments, Inc. — 20 clearances
- Grason-Stadler, Inc. — 12 clearances
- Bio-Logic Systems Corp. — 9 clearances
- Otodynamics, Ltd. — 7 clearances
- Tracor Instruments, Inc. — 7 clearances
