NeuroEars-Anna™

NeuroEars-Anna™ is software that analyzes eye movements using a head-mounted display with eye-tracking cameras to assist trained medical professionals in nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The system performs 13 vestibular tests including spontaneous nystagmus, gaze-evoked nystagmus, dix-hallpike, caloric, and smooth pursuit tests. It is intended for use in individuals aged 12 years and older by trained personnel such as audiologists, ENT surgeons, and doctors.

The subject device uses a commercially available head-mounted display (FOVE VR headset) with 2D/3D eye-tracking cameras running on a Windows PC platform, versus the predicate device which uses goggles with mounted cameras. Both devices perform identical vestibular tests and analyze eye movement data. The subject device was validated to meet ANSI S3.45 standards with eye-tracking accuracy within 1.0° error and minimum 60 Hz frame rate.

ANSI S3.45-2009 (Reaffirmed April 16, 2024) for eye-tracking specifications in videonystagmography. Performance testing verified frame rate (120 Hz minimum), eye-tracking accuracy (horizontal and vertical error within 1.0°), and visual fixation point requirements (0.2–0.4 Hz movement within 20° horizontal field of view).

NeuroEars-Anna™ has identical indications for use, intended user and patient populations, and vestibular test functionality as the predicate I-Portal device (K143607). Although the subject device uses a head-mounted VR display instead of traditional goggles, clinical testing demonstrated it provides equivalent eye-movement measurements, and performance testing confirmed it meets the same ANSI S3.45 technical standards. The minor hardware difference does not raise new safety or effectiveness concerns because both capture and analyze eye movement data identically for vestibular diagnostic purposes.