The Cognixion ONE is a mixed-reality headset combining EEG-based BCI with augmented reality and an AI-powered augmentative and alternative communication (AAC) platform. The headset uses passive EEG electrodes to detect P300 event-related potentials and SSVEP signals as selection mechanisms, combined with eye tracking and facial expression detection, to enable communication without speech or hand movement. An onboard neural network trained on the user's individual brain patterns predicts intended communication targets. The platform targets individuals with ALS, cerebral palsy, spinal cord injury, and other conditions affecting speech and movement.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗