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Terminal/Device DB/Fluent Subscalp BCI
subscalpnoneinvestigational

Fluent Subscalp BCI

Implant Type
subscalp
Electrodes
144
Channels
144
FDA Status
none
Clinical Stage
Preliminary human testing at St Vincent's Hospital Melbourne (worn 144-electrode array cap); implanted subscalp form not yet demonstrated in humans
Status
investigational
About

Fluent is a University of Melbourne spinout developing a subscalp speech brain-computer interface — a device that sits beneath the scalp but outside the skull, deliberately trading maximum signal fidelity for a dramatically lower surgical risk profile than fully intracortical systems. That places it in a tier below ECoG and intracortical approaches but potentially well above scalp EEG in both signal quality and practical deployability. In preliminary human testing at St Vincent's Hospital Melbourne, a 144-electrode array cap placed over the motor cortex allowed an AI model to correctly identify a target phrase from a pool of 128 options with 96% accuracy; participants wore the cap while speaking, miming words, and imagining different phrases. Co-founder Dr. Tim Mahoney reports that signals captured beneath the skull are comparable to those captured outside it — a claim not yet independently replicated in peer-reviewed form.

Target Conditions
speech restorationALSlocked-in syndromesevere speech impairment
Milestones
2026-07Preliminary human testing: 144-electrode array identifies target phrase from 128 options at 96% accuracy
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗