Paradromics gets FDA approval to start a speech-restoration trial
The Connexus high-data-rate implant can now begin a clinical study in people who have lost the ability to speak.
Austin-based Paradromics has received FDA approval to begin a clinical trial of its Connexus brain-computer interface. The first goal is to restore speech for people with severe paralysis who can no longer talk.
The study will start with two participants. The company plans to expand it after a year of safety and performance data.
Background
Connexus is designed for high data rates. It uses hundreds of microwire electrodes to record from individual neurons, because decoding natural speech needs far more information than moving a cursor. In June 2025 Paradromics briefly implanted the device in a patient during epilepsy surgery, its first human recording.
Why it matters
An approved trial (an “IDE”, or investigational device exemption) is the step that lets a company study a device long-term in people. It moves Paradromics into the same clinical stage as Neuralink, Synchron and Precision.
Learn more: Clinical trial pathway · Microelectrode array · Paradromics in the Directory