SmartOAE
by Intelligent Hearing Systems
510(k) K964426
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964426 | Date3 Feb 1997 | StatusActive |
Official records
- FDA 510(k) database K964426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
SmartOAE is a diagnostic system that performs otoacoustic emissions (OAE) testing, including Distortion Product (DPOAE) and Transient Evoked (TEOAE) measurements. The system provides automatic probe‑fit calibration and generates clear pass/refer results for hearing screening and diagnostic evaluations.
The device was cleared by the FDA through a traditional 510(k) submission (K964426) on 1997‑02‑03 and is classified as a Class II audiometer‑type device. It is supplied as a reusable software‑based system for clinical use, with no specific sterility or single‑use claims noted in the data.
Devices cleared under K964426
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Aria M011160 | M011160 | 00817020021126 | — | On the market |
| OAE 10D Probe M032103 | M032103 | 00817020020273 | — | On the market |
| OAE 10D Probe M032103G | M032103G | 00817020029993 | — | On the market |
| OAE Probe OP23 M032200 | M032200 | 00817020021133 | — | On the market |
| SmartDPOAE Software M813000 | M813000 | 00817020020853 | — | On the market |
| Universal Smart Box M011110 | M011110 | 00817020020051 | — | On the market |
| USB Jr Duet M010300 | M010300 | 00817020020075 | — | On the market |
Similar devices
Other devices filed under FDA product code EWO (Audiometer).
- AUDIOMETER DA 323 by Futuremed Div. of Future Impex Corp.
- HEARID WIDEBAND MIDDLE EAR POWER ANALYZER by Mimosa Acoustics, Inc.
- ACAM 5 AUDIOMETER SYSTEM by Acousticon GmbH
- MA25 - PORTABLE AUDIOMETER, MODIFICATION by Maico Hearing Instruments, Inc.
- ST 20 PORTABLE AUDIOMETER by Maico Hearing Instruments, Inc.
- TITAN by Interacoustics A/S
- VOYAGER 522 by Madsen Electronics, Inc.
- Amplivox Otosure by Amplivox, Ltd.
- AT-2 by Qualitone
- Interacoustics Callisto by Interacoustics A/S
Other devices from Intelligent Hearing Systems Corp.
Questions
AI-generated answers, 22 Sep 2026
What types of otoacoustic emissions tests does the SmartOAE support?
The SmartOAE system supports both Distortion Product OAE (DPOAE) and Transient Evoked OAE (TEOAE) measurements. These are objective hearing assessment methods that measure the cochlear response to sound, useful for screening and diagnostic evaluations.
What kind of output does the SmartOAE provide after testing?
The SmartOAE generates clear pass/refer results for hearing screening and diagnostic evaluations. This binary outcome helps clinicians quickly determine whether further assessment is needed based on the otoacoustic emissions response.
What regulatory pathway did the SmartOAE follow for market clearance?
The SmartOAE was cleared through a traditional 510(k) submission to the FDA under number K964426. The decision was made on February 3, 1997, and the device was determined to be substantially equivalent to existing audiometer-type devices.