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Audiotraveller Model AA222

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022728

by Interacoustics A/S, Assens

Identifiers

510(k) Number
K022728 FDA 510(k)
FDA Product Code
ETY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1090 FDA 510(k)
Regulation Number
874.1090 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Audiotraveller Model AA222 is an Audiometer, Tympanometer (ETY classification) designed for measuring auditory function and middle ear impedance. It performs tympanometry at 226 Hz (upgradeable to 1000 Hz), audiometry, and the Stenger test to assess hearing thresholds and middle ear status.

This device is intended for use in clinical settings such as hospitals, ENT clinics, and audiology offices by trained operators. Supplied as a reusable electronic instrument, it requires no sterility processing and is not MRI-compatible. Authorized under FDA 510(k) clearance (K022728), it operates within Class II regulatory standards for auditory testing.

Frequently asked questions

What clinical applications is the Audiotraveller AA222 designed for in a hospital or clinic setting?

The Audiotraveller AA222 is specifically designed for measuring auditory function and middle ear health, making it ideal for assessing hearing thresholds and diagnosing conditions related to the ear, nose, and throat. It performs tympanometry (measuring middle ear pressure and mobility), audiometry (hearing threshold testing), and the Stenger test (used to evaluate hearing asymmetry). This makes it suitable for use in hospitals, ENT clinics, and audiology offices by trained professionals.

Is the Audiotraveller AA222 a single-use or reusable device, and does it require any special handling?

The Audiotraveller AA222 is a reusable electronic instrument, meaning it is designed for repeated use within a clinical setting. Since it is not sterile, it does not require sterilization processing. However, proper cleaning and maintenance as per manufacturer guidelines are essential to ensure accurate and reliable performance over time.

What types of tests can the Audiotraveller AA222 perform, and what frequencies does it use?

The Audiotraveller AA222 performs three key tests: tympanometry (measuring middle ear function) at a standard frequency of 226 Hz, which can be upgraded to 1000 Hz, audiometry (testing hearing thresholds across frequencies), and the Stenger test (used to assess hearing asymmetry by comparing responses to competing auditory stimuli). These tests help evaluate both peripheral and central auditory pathways.

How is the Audiotraveller AA222 regulated, and what does that mean for its use in clinical settings?

The Audiotraveller AA222 is authorized under FDA 510(k) clearance (K022728) and falls under Class II regulatory standards for auditory testing devices. This means it has undergone a review process to demonstrate substantial equivalence to a legally marketed device, ensuring it meets safety and performance requirements for clinical use in measuring auditory function and middle ear impedance. Clinicians can rely on its regulatory clearance for use in hospitals, ENT clinics, and audiology offices.

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: AA222 | Tympanometer and audiometer | Interacoustics, Interacoustics AA222 Instructions For Use Manual, PDF Instructions for Use - EN AA222 - Interacoustics, AUDIOTRAVELLER, MODEL AA222 (K022728) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Interacoustics A/S, Assens

Sources (1)

  • FDA 510(k) K022728 24 fields · synced Sep 19, 2026