# DSP Screening Audiometer

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

- Canonical page: <https://devicerts.com/devices/dsp-screening-audiometer-ewo>
- Manufacturer: [Micro Audiometrics Corp.](https://devicerts.com/manufacturers/micro-audiometrics-corp) (United States, FDA 510(k) applicant)
- Name in the registry: DSP SCREENING AUDIOMETER
- Device class: Class II (US FDA)
- FDA product code: EWO

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The DSP Screening Audiometer is a diagnostic device classified as an audiometer, designed to measure hearing sensitivity. It employs digital signal processing (DSP) technology to assess pure-tone air conduction thresholds across standard audiometric frequencies, aiding in the screening and evaluation of hearing function in clinical or screening settings.

This device is intended for use in clinical environments by trained professionals, such as audiologists or ENT specialists. Supplied as a reusable instrument, it requires no sterilization but must be cleaned and maintained according to manufacturer guidelines. The device is not MRI-safe and is regulated under FDA 510(k) clearance (K924543) with a classification of Class II (EWO). No information on sterility or single-use is provided in the specifications.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K924543 · decision 1993-02-26 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K924543 [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: DSP Screening Audiometer, Micro Audiometrics Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/dsp-screening-audiometer-ewo (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/dsp-screening-audiometer-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/dsp-screening-audiometer-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.