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Speech-restoring brain chip gets FDA approval for human trial
November 21, 2025
The trial will investigate the Paradromics BCI for speech restoration
Paradromics
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US brain-computer-interface startup Paradromics is quickly establishing itself as a major player in the neural-device space, with the Food and Drug Administration (FDA) green-lighting a human trial to test its ability in restoring speech in people with paralysis.
The Austin-based company, which has already received several Breakthrough Device approvals from the FDA, has been granted Investigational Device Exemption (IDE) status for the Connect-One Early Feasibility Study (EFS) using the Connexus BCI. It’s the first company to be given IDE approval for speech restoration with a fully implantable BCI.
Researchers will investigate the safety and efficacy of the Connexus BCI, aiming to help paralyzed patients regain speech and computer control capabilities, allowing people to communicate either through text or synthesized voice.
“Built for long-term medical use, Connexus is the first high-data-rate BCI designed to deliver high performance for the user,” the company states.
The device is built out of medical-implant-grade metals, with a titanium-alloy body and more than 400 platinum-iridium electrodes that will be positioned next to neurons, with on-chip processing to record a large amount of brain signals. Each electrode is smaller than 40 microns – thinner than a human hair.
In the trial, the BCI and its components – cortical module, internal transceiver and extension lead – will be surgically implanted under the skin, with the electrodes extending just below the brain’s surface in order to collect signals from individual neurons in the motor cortex. This information is then sent along the thin subcutaneous cable that connects to the implanted transceiver in the chest, which then wirelessly transmits data by a secure optical link to a second transceiver worn by the patient. This external transceiver powers the system through inductive charging, not unlike wireless smartphone charging. Finally, the data is transmitted to a small computer with advanced language models and AI, which analyzes the brain data to determine what the patient wanted to say or do and turns it into words (text on a screen/synthesized speech) or enables control of digital devices.
“We’re very excited about bringing this new hardware into a trial,” says Matt Angle, chief executive of Paradromics.
The trial is very small – just two people to begin with – and they’ll have the 7.5-mm-wide BCI inserted 1.5 mm into the brain to record signals from individual neurons. The volunteers will each have one electrode array implanted in the motor cortex region that controls the lips, tongue and larynx. The participants will then imagine speaking sentences presented to them, with the information being relayed from the neurons to the external computer. The system then learns what patterns of neural activity correspond to each intended speech sound, personalizing the technology.
It’s the first BCI trial targeting synthetic-voice generation – where the information will be converted to audio in real time, based on old recordings of the participants’ talking.
The trial will also investigate whether the BCI can detect activity from imagined hand movements – this would make operating a computer cursor feasible.
If the initial stage of the trial delivers positive outcomes, it’s expected to expand to a study group of 10, with two participants receiving two implants to boost signal-capturing power.
“It’s an exciting step,” says Mariska Vansteensel, a BCI researcher at the University Medical Center Utrecht in the Netherlands. “For the field to move forward towards clinical applications, a fully implantable system is the only way to go.”
Sources: Nature, Paradromics
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