# SmartOAE

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/smartoae-ewo>
- Manufacturer: [Intelligent Hearing Systems](https://devicerts.com/manufacturers/intelligent-hearing-systems-corp) (United States)
- Name in the registry: SMARTOAE
- Device class: Class II (US FDA)
- FDA product code: EWO

## Overview

*AI-generated summary, 2026-09-22. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K964426 · decision 1997-02-03 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K964426 [FDA 510(k)]
- FDA product code: EWO [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 874.1050 [FDA 510(k)]
- Advisory committee: Ear, Nose, Throat [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: SmartOAE, Intelligent Hearing Systems. deviCERTS medical device catalogue. https://devicerts.com/devices/smartoae-ewo (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/smartoae-ewo.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/smartoae-ewo
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.