(57 days)
Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.
Not Found
The provided text does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device. It is an FDA 510(k) clearance letter for the Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer, stating that the device is substantially equivalent to legally marketed predicate devices and outlining its indications for use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this 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.