(123 days)
The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).
Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.
These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.
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This document is a 510(k) clearance letter from the FDA for a device called "HEARLab ACA". It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.
Therefore, I cannot extract the requested information from the provided text.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).