For safe cochlear implantation in children under 2 years of age, the implant assembly must not adversely affect adjacent tissues or compromise head growth. Furthermore, growth changes and tissue responses should not impair the function of the device.
Dummy receiver-stimulators, interconnect plugs, and leadwire-lengthening systems were implanted for periods of 36 months in the young monkey to effectively model the implantation of the young child. The results show that implanting a receiver-stimulator package has no adverse effects on skull growth or the underlying central nervous system. The system for fixing the electrode at the fossa incudis proved effective. There was marked osteoneogenesis in the mastoid cavity, resulting in the fixation of the leadwire outside the cochlea.
This study provides evidence for the safety of cochlear implantation in young subjects.