(56 days)
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.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.