(90 days)
The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.
Automatic Self-Operated Screening Audiometer (ASAM) Device
This document is a marketing clearance letter from the FDA for an Automatic Self-Operated Screening Audiometer Device (ASAM). It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
§ 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.