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SmartOAE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964426

by Intelligent Hearing Systems

Identifiers

510(k) Number
K964426 FDA 510(k)
FDA Product Code
EWO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1050 FDA 510(k)
Regulation Number
874.1050 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

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.

Is the SmartOAE designed for single use or is it reusable?

The SmartOAE is supplied as a reusable software-based system intended for clinical use. The device data does not indicate any single-use design or disposable components, and there are no sterility claims associated with the system.

Does the SmartOAE include automatic probe-fit calibration?

Yes, the SmartOAE includes automatic probe-fit calibration as part of its testing workflow. This feature helps ensure that the test probes are properly positioned in the ear canal before measurements are taken, which contributes to reliable pass/refer results.

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.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SmartOAE: DPOAE & TEOAE Testing Software - Intelligent Hearing Systems, Home - Intelligent Hearing Systems, SmartOAE - Intelligent Hearing Systems - PDF Catalogs | Technical ..., SmartOAE System from Intelligent Hearing Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intelligent Hearing Systems

Sources (1)

  • FDA 510(k) K964426 24 fields · synced Sep 22, 2026