The FDA has granted an investigational device exemption for the first in-human trial of a neural-enabled prosthetic hand, according to a press release. The device was developed at Florida International University.
“The system is intended to restore the sense of touch, and hand opening, which would allow users to precisely differentiate the size and fragility of various objects,” Ranu Jung, PhD, interim dean of the College of Engineering and Computing at Florida International University and a Wallace H. Coulter Eminent Scholars Chair in biomedical engineering, said in the release. “The prostheses that exist today make it difficult for amputees to manipulate delicate and small objects because they cannot feel them.”
The neural-enabled system stimulates nerves in the arm to create sensation. According to the release, it features the first fully implantable, wirelessly controlled, class III device with electrodes that can be surgically implanted within the nerves of a residual arm.
The system works by sending small electrical pulses to specific nerves in the arm. Wires are placed within nerve bundles in the arm and connected to an electrical stimulator. Sensors embedded in the prosthetic hand wirelessly send signals to the implanted stimulator, which elicits sensation by delivering weak electrical pulses through the electrodes. The person should be able to sense their hand opening and grip items when the prosthetic hand encounters an object, the release noted.
Participants in the trial will have daily access to use the system outside of the laboratory. The system is not approved by the FDA for U.S. commercial distribution. However, if the trial is successful, the researchers plan to continue testing through larger clinical trials and eventually seek such approval, according to the release.
Disclosure: The researchers report funding from the NIH and the Defense Advanced Research Projects Agency.