(85 days)
The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only.
The HearID system comes in two versions: HearID_b-wbMEPA, and HearID_e-wbMEPA, where the difference is the variation of the hardware platform.
The provided text is a 510(k) premarket notification approval letter for the HearID Wideband Middle Ear Power Analyzer. It confirms that the device is substantially equivalent to a legally marketed predicate device.
*However, this document does not contain any information regarding specific acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about comparative effectiveness studies.
The letter focuses on regulatory approval based on substantial equivalence, rather than detailing the results of performance studies against predefined acceptance criteria. To provide the requested information, a different document, such as the actual 510(k) submission or a clinical study report, would be necessary.
§ 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.