In the rapidly advancing field of brain-computer interfaces, two companies—Elon Musk’s Neuralink and rival firm Cognixion—are racing to transform how people with severe speech impairments communicate, using cutting-edge technologies that promise to restore voices once thought lost.
On May 1, Elon Musk’s Neuralink announced on the social media platform X that the brain-computer interface (BCI) company has been granted a breakthrough designation by the U.S. Food and Drug Administration (FDA). This designation applies to Neuralink’s device, which is designed to restore communication for individuals with severe speech impairments.
Following controversy over federal cuts under the Trump Administration, several FDA employees were let go, some of whom were involved in reviewing information involving past controversies associated with Neuralink.
Last year, the FDA granted Neuralink’s device a special designation to expedite its development and review. Despite consistently high performance ratings in their roles, two sources said the FDA reviewers were dismissed for “performance reasons.” Their supervisors were not consulted in advance and only learned of the terminations directly from the employees.
Neuralink’s ambitions extend beyond speech restoration, targeting conditions ranging from paralysis and blindness to memory loss, epilepsy, Parkinson’s disease, and depression. But Neuralink is not the only player in the BCI race. Cognixion, a competing company, is pursuing similar goals with a noninvasive approach compared to Neuralink’s neural implants.
According to its website, Cognixion’s mission is to unlock speech for hundreds of millions of people worldwide affected by communication disabilities. The company aims to achieve this by providing affordable and accessible AI-powered technologies.
Cognixion envisions a future where thousands of creators, scientists, artists, engineers, change-makers, and philosophers (like Stephen Hawking) can contribute to society now that they have a voice.
Cognixion CEO and Founder Andreas Forsland recently posted on his LinkedIn account following Neuralink’s announcement that it had been granted FDA Breakthrough Device Designation.
“Welcome to the party, Neuralink. Thought to Speech, and BCI for Access. We know a thing or two about this. Good luck with your trials,” Forsland wrote.
“Cognixion received FDA Breakthrough Designation for BCI-based communication in 2023. 🙂 Care to wager a race to see who can help more people first?” Forsland added.
While both Cognixion and Neuralink aim to develop brain-computer interfaces and enhance the connection between the human brain and technology, their approaches and visions differ significantly. Cognixion offers a non-invasive wearable device to assist individuals with disabilities in real-time communication. In contrast, Neuralink is developing an invasive neural implant for medical uses and potential long-term cognitive enhancement.
Cognixion ONE, the company’s flagship product, is the world’s first wearable BCI combined with augmented reality (AR). It targets people with comprehensive communication needs, such as individuals living with ALS, cerebral palsy, or Locked-In Syndrome.
Unlike traditional devices, Cognixion ONE is built to be mobile, wireless, and fully integrated with AI for speech generation, home automation, and communication — all without the need for wires, screens, or bulky equipment.
Users can control the system using head movement, brain signals, or switches, making it accessible to individuals with a wide range of motor abilities, including those for whom eye-tracking isn’t reliable. It features predictive keyboards, radial sentence builders, and a mirrored speech/text display lens, allowing communication even in noisy or private environments. The headset also functions as a smart home hub, offering 4G connectivity and cloud-based AI services.
Developed in collaboration with clinicians, engineers, and a diverse team of over 60 users with disabilities, Cognixion ONE represents a breakthrough in accessible, inclusive technology. It empowers people to “Think it. Say it. Do it.” with greater independence and dignity than ever before.
Chrissy Newton is a PR professional and founder of VOCAB Communications. She currently appears on The Discovery Channel and Max and hosts the Rebelliously Curious podcast, which can be found on The Debrief’s YouTube Channel on all audio podcast streaming platforms. Follow her on X: @ChrissyNewton, Instagram: @BeingChrissyNewton, and chrissynewton.com.