# Sera Audiometer

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

- Canonical page: <https://devicerts.com/devices/sera-ewo>
- Manufacturer: [Interacoustics A/S](https://devicerts.com/manufacturers/interacoustics-a-s) (FDA registration: Denmark)
- Name in the registry: Sera
- 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 Sera is a Class II audiometer, a diagnostic device designed to measure hearing thresholds and assess auditory function. It employs pure-tone air and bone conduction testing, speech audiometry, and impedance measurements to evaluate hearing sensitivity across different frequencies and pathways. The device is intended for clinical use in otolaryngology and audiology settings to aid in the diagnosis and management of hearing disorders.

The Sera audiometer is supplied as a reusable, non-sterile medical device intended for use in clinical environments such as hospitals, audiology clinics, and ENT (ear, nose, and throat) practices. It operates within standard electrical safety parameters and is not classified as MRI-safe or MRI-conditional. The device is regulated under FDA 510(k) clearance (K173567) and adheres to regulatory requirements outlined in 21 CFR 874.1050. It is distributed with accompanying software and calibration tools, requiring periodic maintenance as specified in the manufacturer’s instructions.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K173567 · decision 2018-02-14 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K173567 [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: Sera Audiometer, Interacoustics A/S. deviCERTS medical device catalogue. https://devicerts.com/devices/sera-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/sera-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/sera-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.