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The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

The OECD Council adopted the Recommendation on Responsible Innovation in Neurotechnology in December 2019, guiding governments with nine principles.

Vanderbilt University Medical Center has developed a method that uses post-operative CT scans and image processing to determine the physical relationship between cochlear implant electrodes and the neural interface, allowing sub-optimally positioned electrodes to be switched off for a customized map. Cochlear implants are surgically implanted devices that restore hearing by electrically stimulating the auditory nerve, and their programming has traditionally ignored where the electrodes actually sit. The trial tested whether this individualized image-guided programming improves hearing and speech outcomes in pediatric recipients, with hearing measures collected at baseline, 12 months and 24 months; it has been completed, but results have not been posted.

Johns Hopkins University is conducting an early feasibility study to evaluate the safety and efficacy of the Bidirectional Cortical Neuroprosthetic System (BiCNS). The system comprises NeuroPort Microelectrode Array Systems, NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The trial enrolls patients with tetraplegia and quadriplegia and is currently recruiting.