VOICE Speech Restoration Trial

by NeuralinkUS

Early Feasibility Study using N1 implant to restore communication in people with severe speech impairment from ALS, stroke, spinal cord injury, cerebral palsy and MS. Implant translates intent to speech.

PilotStage 3 of 5

Early trial: two participants implanted. FDA Breakthrough Device Designation granted May 2025.

Checked 10 Oct0 updates this week

Milestones

Next · Full VOICE trial enrollment target
  1. VOICE trial enrollment beginsOct 2025Complete.
  2. FDA grants Breakthrough Device Designation for speech restorationMay 2025Complete.
  3. Second participant Kenneth Shock implantedJan 2026Complete.
  4. Kenneth demonstrates speech output via implantMar 2026Complete.
  5. Full VOICE trial enrollment targetTarget 2027Not yet reached.

Upcoming

  1. 2027Full VOICE trial enrollment target (next)
  2. 2027VOICE trial enrollment continues
Primer