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EchoMaster OAE Analyzer

by Hortmann AG

510(k) K994033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994033 Date24 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Hortmann Echomaster Oae Analyzer
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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EchoMaster OAE Analyzer is a diagnostic device designed to measure otoacoustic emissions (OAEs), which are sounds produced by the inner ear. It evaluates cochlear function and is used to assess hearing health, particularly in newborns and infants, as well as in clinical audiology settings to detect potential hearing impairments or abnormalities in the auditory pathway.

This device is supplied as a reusable medical instrument and is classified under the Ear, Nose, and Throat (ENT) category with product code EWO. It operates under FDA 510(k) clearance (K994033) and falls under the Traditional 510(k) review pathway. The device is regulated under CFR 874.1050 and is intended for use in clinical environments where audiological assessments are conducted.

Other devices from Hortmann AG

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EchoMaster OAE Analyzer used for?

    The EchoMaster OAE Analyzer is designed to measure otoacoustic emissions (OAEs), which are sounds produced by the inner ear. These emissions help evaluate cochlear function and are used to assess hearing health, particularly in newborns and infants, as well as in clinical audiology settings to detect potential hearing impairments or abnormalities in the auditory pathway.

  • Is the EchoMaster OAE Analyzer reusable or single-use?

    The EchoMaster OAE Analyzer is supplied as a reusable medical instrument. It is intended for repeated use in clinical environments where audiological assessments are conducted, ensuring durability and consistent performance over time.

  • What regulatory pathway does the EchoMaster OAE Analyzer follow?

    The EchoMaster OAE Analyzer is regulated under the FDA’s Traditional 510(k) review pathway and has received FDA 510(k) clearance (K994033). It is classified under CFR 874.1050 and falls under the Ear, Nose, and Throat (ENT) category with product code EWO.

  • Can this device be used for newborn hearing screenings?

    Yes, the EchoMaster OAE Analyzer is particularly well-suited for newborn hearing screenings. Its ability to measure otoacoustic emissions makes it an effective tool for early detection of hearing impairments in infants, enabling timely intervention and support.

  • What is the product code and classification for the EchoMaster OAE Analyzer?

    The EchoMaster OAE Analyzer is classified under the Ear, Nose, and Throat (ENT) category with the product code EWO. This classification aligns with its intended use in audiological assessments and cochlear function evaluation.