(183 days)
This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
This request cannot be fulfilled. The provided text is a truncated FDA 510(k) clearance letter for an audiometer. It does not contain any information regarding acceptance criteria, study design, or performance data for the device. Therefore, I cannot extract the requested information to describe the acceptance criteria and the study that proves the device meets them.
§ 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.