The U.S. Food and Drug Administration (FDA) has approved the first human trial for Paradromics’ fully implantable brain-computer interface (BCI), which could restore speech for people with paralysis. This marks a significant development in the field of neural technology, offering new hope for individuals who have lost their ability to communicate due to conditions like ALS, stroke, or spinal cord injuries.
Paradromics, a neurotechnology startup based in Austin, has received Investigational Device Exemption status for the Connect-One Early Feasibility Study. This trial will explore whether the Connexus BCI, a fully implantable device, can effectively restore speech by converting neural activity into text or a synthesized voice. The approval comes as the company competes in a rapidly growing market, positioning it as a key player in the development of advanced neural interfaces.
The Connexus BCI is designed to capture detailed neural signals that support real-time communication for patients who cannot speak. It uses high-resolution electrodes and an implanted wireless setup to record activity from individual neurons involved in speech formation. The device’s titanium body features over 400 platinum-iridium electrodes placed just below the brain’s surface. Each electrode is thinner than a human hair, ensuring precise signal capture.
Surgeons will place the implant under the skin and connect it with a thin cable to a wireless transceiver in the chest. This transceiver sends data through a secure optical link to an external unit worn on the body. The external unit, which is powered by inductive charging similar to wireless phone chargers, serves as the system’s power source. The collected signals are then transmitted to a compact computer running advanced language models, which analyze neural activity and convert it into text or a synthetic voice based on the user’s past recordings.
The trial will begin with two participants, each receiving a 7.5-millimeter-wide electrode array placed in the motor cortex at the site that controls the lips, tongue, and larynx. During training, volunteers will imagine speaking sentences, allowing the device to learn the neural signatures of each sound. This trial will be the first to formally target real-time synthetic voice generation, as well as to evaluate the system’s ability to detect imagined hand movements and translate them into cursor control.
If the trial’s early results are promising, the study could expand to ten participants, with some receiving dual implants to capture a richer set of signals. Paradromics has emphasized that the technology could make a significant difference for people who have lost the ability to communicate, improving their independence and integration into daily life. The device could also allow for hands-free computer control, which may significantly enhance quality of life.
Paradromics has positioned itself in the middle of the BCI competition, with companies like Synchron and Neuralink leading in different approaches. Synchron uses a stent-like device to record broad neural patterns, while Neuralink employs flexible threads with many recording sites to capture high-bandwidth signals from individual neurons. Paradromics’ approach focuses on long-term stability and precision, which may offer advantages for everyday communication applications.
The approval of the trial represents a crucial step forward in the quest for assistive communication technologies. If successful, this technology could reshape how people with severe motor impairments interact with the world, potentially transforming the landscape of neurotechnology and assistive devices for the future.