(45 days)
The Integrity V500 with DPOAE and TEOAE test options is indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function by measuring, recording, and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.
DPOAE and TEOAE tests do not measure hearing per se, but measure whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.
The Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
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This is a 510(k) premarket notification for the Vivosonic Integrity Model V500, a device for measuring otoacoustic emissions (DPOAE and TEOAE Test Option) and auditory evoked potentials (ABR/ASSR Test Option). This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a pre-market submission demonstrating that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, indications for use, and performance to a predicate device already on the market, rather than presenting a novel study to establish performance against pre-defined acceptance criteria (as might be seen in a de novo classification or PMA pathway).
Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on regulatory approval based on substantial equivalence to a predicate device.
§ 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).