(85 days)
TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.
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The provided text is a 510(k) clearance letter from the FDA for a device called TEOAE25, an accessory to the EP15 or EP25 platform used to test cochlea functions.
While the document confirms that the device has been reviewed and found "substantially equivalent" to legally marketed predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and device performance studies.
The letter focuses on regulatory approval based on equivalence, not on a detailed breakdown of performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from 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.