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The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

This is a regulatory letter from the FDA, approving the Interacoustics Audiotraveller, Model AA222. The letter does not contain a detailed study report with acceptance criteria and device performance results. Therefore, I cannot provide most of the requested information based solely on the provided text.

Here's what I can infer and what is explicitly stated:

Information from the document:

• Trade/Device Name: Audiotraveller, Model AA222
• Regulation Number: 21 CFR 874.1090
• Regulation Name: Auditory Impedance Tester
• Regulatory Class: Class II
• Product Code: ETY
• Intended Use: For use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer.

Limitations:

The provided document is an FDA clearance letter based on a 510(k) submission. A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed acceptance criteria and performance studies as might be seen for a PMA (Premarket Approval) device or for novel technologies.

Therefore, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used, training set sample size, or how ground truth was established for the training set.

The FDA's decision is based on a review of the submitter's assertion that the device is substantially equivalent to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The specific data supporting such a claim would be in the 510(k) submission itself, not in the FDA's clearance letter.

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