Neuralink to Begin US Speech Trial in October with FDA Approval

Neuralink is currently conducting five other clinical trials involving implants designed to control electronic devices such as computers or robotic arms.

Neuralink Corp., the brain implant company founded by Elon Musk, plans to begin a clinical trial in the United States in October to test its device for translating thoughts into text.

The move could create new avenues for people with speech impairments to communicate.

The US Food and Drug Administration (FDA) has granted Neuralink an investigational device exemption for the trial, allowing the company to test an unapproved device. Neuralink is currently conducting five other clinical trials involving implants designed to control electronic devices such as computers or robotic arms.

The speech-focused trial marks a significant shift, as there are currently no commercially available implants that directly read speech from the brain.

“We’re currently envisioning a world where in about 3 to 4 years, there will be someone who’s otherwise healthy who’s going to get a Neuralink,” said DJ Seo, Neuralink’s president, in a lecture at the Korea Foundation for Advanced Studies in Seoul.

Seo said the upcoming trial would test the ability to directly capture imagined speech. “If you’re imagining saying something, we would be able to pick that up,” he explained.

During the presentation, Seo added that the company is working toward eventual consumer technology applications. “We think that it’s actually possible to demonstrate abilities to speak to the latest AI model, or LLM models, at the speed of thought, even faster than how you’re speaking, and being able to potentially get that information back through your AirPods, effectively closing the loop,” he said.

The company has previously outlined ambitions beyond speech restoration, including potential treatments for conditions such as blindness and Parkinson’s disease. However, it does not yet have any devices approved for commercial use.

Neuralink aims to begin with patients with severe medical conditions and expand to healthy individuals by 2030. Seo noted that the company ultimately hopes to implant devices in 20,000 people annually by 2031.

An October start for the speech trial represents a delay from the company’s earlier timeline. In July, Seo said that implants in the speech cortex would begin by the end of the current quarter.

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