Synapsys VHIT

The Synapsys VHIT is a medical device that assesses the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements. It uses a remote infrared camera positioned 90 cm from the patient to track eye and head motion without requiring the patient to wear goggles.

Unlike the predicate ICS Impulse, which uses head-mounted goggles with an accelerometric sensor and infrared camera, Synapsys VHIT employs a remote camera with built-in infrared illumination and software-based eye tracking and head pose estimation algorithms. Synapsys VHIT can record and analyze both eyes during lateral head impulses, whereas ICS Impulse tracks only the right eye. Both devices enable comprehensive six-canal assessment and provide identical clinical metrics (VOR gain, head peak velocities, covert saccade data) and similar visualization outputs.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 82304-1, IEC 62471, ISO 14971, ISO 15223-1, ISO 20417, ISO 17664-2, ANSI ASA 53.45, IEC 81001-5-1, and IEC TR 60601-4-2.

Comparative bench testing demonstrated that VOR gain measurements between Synapsys VHIT and ICS Impulse fall within a predefined confidence interval of ±0.1 in both pathological and non-pathological subjects, with consistent trajectory patterns. Although the technologies differ substantially (remote camera-based vs. goggle-based), both devices deliver identical clinical outcomes and metrics for assessing vestibular function across all six semicircular canals, establishing functional and clinical equivalence for the same indications for use.