Safety studies for a prototype Nucleus 22 channel implant at high stimulation rates [Abstract]

Abstract

The safe stimulation of neural tissue requires that the stimulation does not produce any toxic electrochemical by-products and that the nerves are not damaged by the very act of responding to the stimulation. The Nucleus stimulator has been proven safe in several chronic animal studies using pulse rates of up to 500 pps and stimulus levels that produced sensations of moderate loudness, and subsequently in clinical use by more that 10,000 patients. Additional safety studies are necessary before considering the use of the Nucleus stimulator at higher rates. This paper describes in vitro investigations using such high rates while animal studies are currently under way to examine the effects of chronic, high rate stimulation.