The specific placement of the electrodes in the bony labyrinth is determined by neuronal signal testing at the time of implant. The superior semicircular canal, lateral semicircular canal and posterior semicircular canal each receive one electrode array.
A National Institutes of Health grant funded the development of the device and its initial testing at the Washington National Primate Research Center. The promising results from those tests led the U.S. Food and Drug Administration, in June, to approve the device and the proposed surgical implantation procedure. Shortly thereafter, the limited surgical trial in humans won approval from the Western Institutional Review Board, an independent body charged with protecting the safety of research subjects.
By basing their invention on cochlear implants whose design and surgical implantation were already FDA-approved, Phillips and Rubinstein leapfrogged scientists at other institutions who had begun years earlier but chosen to develop novel prototypes.
"If you started from scratch, in a circumstance like this where no one has ever treated a vestibular disorder with a device, it probably would take 10 years to develop such a device," Rubinstein said.
The device epitomizes the translational advancements pursued at UW's academic medical centers, he said. He credited the team's skills and its access to the primate center, whose labs facilitated the quick turnaround of results that helped win the FDA's support.
A successful human trial could lead the implant to become the first-choice surgical intervention for Meniere's patients, Phillips said, and spark collaboration with other researchers who are studying more widespread balance disorders.
The first patient will be a 56-year-old man from Yakima, Wash. He has unilateral Meniere's disease and has been a patient of Rubinstein's for about two years.
Source: University of Washington