(23 days)
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
Not Found
This document is an FDA 510(k) clearance letter for an audiometer (Maico MA53) from 1998. It does not contain information about specific acceptance criteria or study results because, for 510(k) clearances, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be seen for PMA submissions or more recent AI/ML device clearances.
Therefore, I cannot provide the requested information based on this document. The document essentially states that the device is substantially equivalent to devices marketed before 1976 and is cleared for marketing.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a more recent device, especially one involving AI/ML components, or a PMA (Premarket Approval) document.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.