FDA Approves First Human Trial of Fully Implantable Brain Chip to Restore Speech
AUSTIN, Texas — November 28, 2025 — The U.S. Food and Drug Administration has approved the first human trial of a fully implantable brain-computer interface developed by neurotechnology startup Paradromics. The device, called Connexus BCI, aims to restore speech for people with paralysis by converting neural activity into text or synthetic voice in real time.
Paradromics received Investigational Device Exemption status to conduct the Connect-One Early Feasibility Study, marking the first approved clinical trial to explore speech restoration using a fully implantable system. The trial will begin with two participants who will each receive a 7.5-millimeter-wide electrode array implanted 1.5 millimeters into the motor cortex region of the brain responsible for controlling the lips, tongue, and larynx.
The Connexus BCI device consists of more than 400 platinum-iridium electrodes embedded in a titanium body, each thinner than a human hair. These electrodes record detailed neural firing patterns from individual neurons involved in speech formation. The implant is placed beneath the skin and connected via a thin cable to a wireless transceiver implanted in the chest. This transceiver communicates through a secure optical link with an external unit worn on the body, which powers the system using inductive charging similar to wireless phone chargers.
Neural signals collected by the device are processed by a compact computer running advanced language models that analyze the activity and translate it into text or a synthetic voice based on the user’s prior recordings. During training sessions, participants will imagine speaking sentences while the device learns the neural signatures associated with each sound.
Paradromics’ trial represents a significant step in the development of brain-computer interfaces focused on speech restoration, offering potential new communication options for individuals unable to speak due to paralysis. Officials said the study will primarily evaluate the safety of the device and its effectiveness in converting neural signals into real-time communication.
The Austin-based company’s progress positions it prominently within the competitive field of neural technology, which is rapidly advancing toward clinical applications that could transform communication for people with severe speech impairments.
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