Development of functional electrical stimulators utilizing cochlear implant technology

In 1983, R. Davis proposed the development of a functional electrical stimulator, based on multi-channel cochlear implant technology, for the restoration of function in spinal cord injured paraplegic subjects. In 1984, the US Veteran Administration funded the initial investigations including animal experiments and purchase of a FES stimulator based on the Nucleus 22 cochlear implant. In 1987, the US Food and Drug Administration approved an Investigational Device Exemption (IDE# G870142) for this FES project. In 1991, the first stimulator was implanted in a 21-year old male paraplegic subject (complete thoracic spinal cord lesion at level #10), who was subsequently able to stand and to perform one-handed tasks for up to 1 h. In 1996-1997 development started on a new multi-function FES system. In 1998, a stimulator was implanted in a 35-year-old male paraplegic subject (complete thoracic spinal cord lesion at level #10). After 8 months of use providing multiple functions including bladder voiding, the implant's internal antenna wire broke. A modified implant (FES 24-B) is due to be implanted in July 2001.