Elon Musk’s Neuralink is preparing to launch a landmark clinical trial in October 2025, aiming to help patients with severe speech impairments, including those affected by spinal injuries, stroke, and ALS, communicate directly using their thoughts. The US Food and Drug Administration has granted Neuralink a "Breakthrough Device" designation and investigational device exemption, allowing fast-track approval for this study. Neuralink’s brain implants are designed to read activity in the speech cortex and convert imagined speech into text, bypassing keyboards or spoken words. The technology also has the potential to allow users to interact with AI models and send information directly through devices such as wireless earbuds.
How Neuralink’s thought-to-text implants work
Neuralink’s implant records activity in the brain’s speech cortex, decoding neural signals to convert thoughts into readable text. Unlike traditional virtual keyboard brain-computer interfaces, this technology directly translates imagined speech into words. Previous human trials since 2024 have allowed participants to control computers, send emails, play video games, and post on social media using only their thoughts.
The upcoming trial is the first FDA-cleared study specifically aimed at decoding speech from brain waves, providing faster and more intuitive communication for patients with severe speech or motor impairments.
Neuralink resolved prior FDA safety concerns before beginning human trials. As of September 2025, at least 12 participants worldwide have received the implant, providing thousands of hours of data on its performance and safety. So far, the devices have demonstrated consistent results without major adverse effects, allowing participants with paralysis to perform complex digital tasks through thought alone.
Industry impact and future plans
Neuralink’s direct thought-to-text approach sets it apart from peers such as Synchron Inc., which develops implants to help paralyzed patients communicate via virtual keyboards. Neuralink envisions expanding its technology beyond patients with medical conditions to otherwise healthy individuals by 2030. Future goals include treating blindness, Parkinson’s disease, and potentially scaling up to 20,000 implants per year globally by 2031.
Neuralink’s upcoming trial represents a revolutionary step in brain-computer interfaces, offering hope to patients with severe speech and motor impairments. By enabling thought-to-text communication, the technology promises to enhance independence, improve quality of life, and pave the way for broader human-AI interaction in the near future.