Future path4 min read
Brain–computer interfaces
BCI
A brain–computer interface picks up brain signals and translates them; it can help people with paralysis communicate by decoding neural signals into words. Implanted devices are still being tested in clinical studies with very few participants.
In 2024 the NIH published the results of a system tested in a man with amyotrophic lateral sclerosis (ALS), which decoded more than 99% of words correctly within a 50-word vocabulary. In 2025 another system tested in a woman with paralysis decoded the entire study vocabulary at a rate of 47.5 words per minute.
The FDA describes implanted interfaces as artificial neural prostheses that connect to the central or peripheral nervous system, and in May 2021 it issued guidance for their non-clinical testing and for feasibility and pivotal studies under an investigational device exemption (IDE). In the official sources we read, we did not find anything indicating approval of any implanted interface for general use.
- In widespread clinical use
- Approved for specific uses
- In clinical trials
- Preclinical
- Concept
Implanted devices tested in clinical studies under an FDA investigational device exemption, with published results from a single participant in each study.
- Restoring communication by speech in people with paralysisIn clinical trials
The 2024 and 2025 results are from a single participant in each study, and researchers see a need to test them on a larger number.23
- Implanted devices for people with paralysis or amputationIn clinical trials
The FDA's 2021 guidance covers feasibility and pivotal studies for these devices.1
Status last checked: · What the maturity levels mean
What is this path?
Brain–computer interfaces can help people with paralysis communicate by decoding neural signals and turning them into words.
The FDA describes implanted interfaces as artificial neural prostheses that connect to the central or peripheral nervous system; see The brain.
Where does the research stand?
In May 2021 the FDA issued guidance covering feasibility and pivotal studies of these devices under the investigational device exemption (IDE).
In 2024 a system was tested in a 45-year-old man with amyotrophic lateral sclerosis, and decoded more than 99% of words correctly within a 50-word vocabulary.
In 2025 a system was tested in a 47-year-old woman who had been paralysed for 18 years after a stroke, and decoded the entire study vocabulary at a rate of 47.5 words per minute.
What separates it from clinical use?
Researchers consider that the device needs further study in a larger number of people.
Earlier interfaces suffered from limited accuracy and required a long calibration period.
The FDA's guidance addresses these devices at the clinical study stage under the investigational device exemption; see Clinical trial phases.
Common questions
Can a patient with paralysis get these devices today?
According to this page's sources, implanted devices are being tested in clinical studies, and their published results come from very few participants, and researchers consider that they need study in a larger number. The possibility of taking part in a trial can be discussed with the treating doctor.13
Questions for your doctor
- Is there a clinical trial suitable for my condition, and what are its participation criteria?
- What assistive communication options are available to me now?
References
- 1U.S. FDA. Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-clinical Testing and Clinical Considerations. www.fda.gov/regulatory-information/search-fda-guidance-documents/implanted-brain-computer-interface-bci-devices-patients-paralysis-or-amputation-non-clinical-testingHealth agencies & guidelines · Accessed 2026-10-08
- 2NIH Research Matters. Brain-computer interface helps paralyzed man speak. www.nih.gov/news-events/nih-research-matters/brain-computer-interface-helps-paralyzed-man-speakHealth agencies & guidelines · Accessed 2026-10-08
- 3NIH Research Matters. Brain-computer interface restores natural speech after paralysis. www.nih.gov/news-events/nih-research-matters/brain-computer-interface-restores-natural-speech-after-paralysisHealth agencies & guidelines · Accessed 2026-10-08
Review status: Edited content · Last updated:
Change log
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Educational content only — no diagnosis, and no substitute for a clinician.