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The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A dcrived measure provided by the SNAP II, the SNAP Index, indicates the patient's brain activity level. The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.

The Everest Biomedical SNAP II EEG monitor is an Electroencephalograph per 21 CFR 882.1400, which has an intended use that is consistent with the CAV/ classification. The SNAP II is substantially equivalent in design, construction, materials, intended use and performance characteristics to the predicate devices.

The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.

The Audioscreener OAE+ABR is a Otoacoustic Emissions and Audiotory Brainstem Response testing device to be used in the evaluation of hearing function. This device is essentially the Audioscreener OAE+ABR unit with additional software required to perform a Transient Evoked OAE in addition to the Distortion Product OAE test.