A Michigan woman who has lost much of her ability to speak used a fully implanted, wireless brain device to choose her own words and communicate in real time, including during a phone call with her grandchildren, according to the company that makes it.
Austin-based Paradromics announced the milestone on Sept. 14. The woman, in her 60s, has a progressive motor neuron disease that has significantly affected her ability to speak, according to the company's announcement.
When the system was switched on for free conversation, her first chosen sentence was "Okay, I have a lot to say," and Paradromics said the system decoded it in real time with no errors, CBS Austin reported. The results are company-reported and have not yet appeared in a peer-reviewed journal.
One Participant, One Early Milestone
For families living with ALS, other motor neuron diseases, or the aftermath of a brainstem stroke, losing speech can mean losing everyday connection, from conversations to phone calls to simple requests.
Surgeons at University of Michigan Health implanted the device in June, according to Michigan Medicine. She is the first participant in the Connect-One Early Feasibility Study, which the FDA allowed to proceed under an investigational device exemption in November 2025. The study focuses on the device's long-term safety, and she will be followed for six years, Paradromics said in June.
The study is led by Dr. David Brandman of UC Davis Health, with Dr. Daniel Rubin at Mass General Brigham and clinical teams at University of Michigan Health.
When Dr. Matthew Willsey, a University of Michigan Health neurosurgeon and study investigator, asked what she would tell someone considering the surgery, she answered through the device: "Don't be afraid. It's a wonderful experience to be able to help others by your participation in the research study."
"The participant and the Paradromics team have achieved a major milestone by demonstrating the ability to speak freely through a fully implantable device designed for clinical use," Willsey said.
How the Connexus System Works
The Connexus is a fully implanted device that records the activity of individual neurons in the brain's outer layer and sends that information wirelessly to an external computer.
When the woman attempts to speak, the system detects brain activity tied to the words she intends. Software then turns those signals into on-screen text and a synthesized voice. The woman retains limited speech, and her husband can often understand her, but communicating with others has become far more difficult.
The company also says data from this participant show distinct brain activity patterns for imagined speech, meaning words a person forms internally without trying to speak. Paradromics described those findings as pointing toward future ways to restore communication. Readers should treat the imagined speech claim as an early company observation, since the reported conversations relied on attempted speech.
Company Claims Versus Independent Evidence
MedicalDaily Evidence Check: This is an early feasibility study with one participant reported so far. Results were announced by the company and have not been published in a peer-reviewed journal. The report suggests the system can decode chosen words in real time for this participant. It does not show long-term safety, how well the system works across different diseases, or how accuracy holds up over months and years. The Connexus device remains investigational and is available only through the study.
Brain surgery carries risks, including infection and bleeding, and implanted hardware raises questions about device maintenance and removal. Monitoring those risks is a main purpose of early feasibility studies. Independent peer review will be important for judging the company's accuracy claims.
Where Brain-Computer Interfaces Stand for Patients
Paradromics is one of several groups working to restore speech. In June, UC Davis researchers reported in Nature Medicine that a man with ALS used a brain implant largely independently at home for communication and computer control, according to a Nature press release. That system still requires him to be connected by cable with help from a caregiver, MIT Technology Review reported. Companies including Neuralink and Synchron are also testing implants.
A fully implanted, wireless design could make daily use outside a lab easier, but that advantage still needs to be shown in more patients over time.
Families interested in research can ask a neurologist about trials or search the federal ClinicalTrials.gov registry. Eligibility is typically limited to adults with severe speech or movement loss from conditions such as ALS or brainstem stroke.
Patients waiting for new options can ask speech-language pathologists about existing tools, including eye-tracking systems and voice banking, which can preserve a person's own voice for future devices. Medicare and many insurers cover some speech-generating devices, though approval can take time.
Speech changes caused by a neurological condition, such as slurring, a weak voice, or trouble swallowing, should be evaluated by a clinician. Sudden speech loss, facial drooping, or weakness on one side of the body can signal a stroke and requires a 911 call.
The report marks a meaningful step for one patient and an early signal for the field, not yet a treatment ready for the many people living with speech loss.
Key Questions Answered
What did Paradromics announce? The company said the first participant in its Connexus brain implant study used the device to communicate her own words in real time, including during a phone call with her grandchildren.
Who is the participant? A Michigan woman in her 60s with a progressive motor neuron disease that has significantly affected her speech.
Can the implant read thoughts? The company says it detected brain patterns tied to imagined speech. The reported conversations relied on attempted speech, and the claims have not been peer-reviewed.
Is the device available to patients? No. It is investigational and available only through the Connect-One early feasibility study.
What should someone with sudden speech loss do? Call 911. Sudden speech loss can be a sign of stroke.
