The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
Life expectancy ≥ 12 months.
Ability to communicate in English
Presence of a stable caregiver
Moderate to high risk for serious perioperative adverse events
Morbid obesity (Body Mass Index > 40)
History of poorly controlled seizures or epilepsy
History of poorly controlled diabetes