This trial focuses on collecting brain data from the visual and parietal cortex to demonstrate the technology's potential for improving communication for severely disabled users, leveraging the capabilities of the Vision Pro.

Cognixion aims to demonstrate the safety and efficacy of its BCI through larger pivotal trials, with regulatory approval contingent on showing improved quality of life and user-friendliness.

The collaboration explores new assistive pathways, including hands-free and voice-free interaction, across mobility, entertainment, education, and work, to enhance real-world independence for users.

Startup Cognixion is launching a clinical trial to integrate its noninvasive brain-computer interface (BCI) technology with the Apple Vision Pro, aiming to help paralyzed individuals communicate through their thoughts.

The company's Axon-R device, a non-invasive neural interface utilizing advanced EEG technology, measures brain activity via visual stimuli and neurofeedback, and will replace Apple's headband in the trial to facilitate communication without physical movement.

Experts recognize the potential of noninvasive BCIs but note challenges such as weaker, noisier brain signals, which AI advancements are expected to help mitigate, making solutions more practical and accessible.

Cognixion’s AI system is personalized to individual speech patterns, enabling near-normal conversation speeds, with alternative control options like eye tracking and head movement, primarily for users with severe motor disabilities.

The study aims to enable natural, conversational communication for people with conditions like ALS, spinal cord injury, stroke-related speech issues, and traumatic brain injury, using brain signals, eye gaze, and head pose without surgery.

Unlike invasive implants by companies like Neuralink, Cognixion’s noninvasive approach seeks wider accessibility and faster deployment, with initial testing involving up to 10 participants with neurological speech impairments.

Apple’s recent protocol updates have allowed for BCI integration with its devices, although the company itself is not developing a BCI, with other firms like Synchron also working on similar projects.

Cognixion’s BCI system includes a custom EEG headband and AI-powered software that interprets brain signals, focusing on visual fixation signals to enable menu selection through mental attention.

This clinical exploration marks one of the first EEG-based BCI trials with Apple Vision Pro, following similar efforts by Synchron with implantable systems, and is expected to run through April 2026, with plans for FDA clearance after a pivotal trial in 2026.