Graeme Clark Collection

Permanent URI for this collection

http://hdl.handle.net/11343/375

Filters

1992 - 1997 3
Reset filters

Settings
Statistics
Citations
Author: Shepherd, Robert × Subject: cochlear implantation × Subject: otology ×

Search Results

Now showing 1 - 3 of 3
  • Item
    Thumbnail Image
    Biological safety
    Clark, Graeme M. ; Shepherd, Robert K. (Singular Publishing, 1997)
    Biological safety has been extensively studied at the Department of Otolaryngology, The University of Melbourne, for cochlear implantation in adults, and subsequently for specific issues in infants and young children. Many of the studies have general applicability to cochlear implantation, but some have specific relevance to the Nucleus (Cochlear Limited) multiple-channel cochlear implant systems, and have been fundamental to their approval by the U.S. Food and Drug Administration (FDA). The Nucleus system was first approved by the FDA as safe and effective for postlinguistically deaf adults in October 1985, and 5 years later, on 27 June 1990, was approved for use in children from 2 years of age and older. The general research questions studied for adults are directly relevant for children and infants, but there are also specific questions that need to be answered when operating on children under 2 years of age.
  • Item
    Thumbnail Image
    Cochlear implantation in young children: studies on head growth, leadwire design and electrode fixation in the monkey model [Abstract]
    Burton, Martin J. ; Xu, J. ; Shepherd, R. K. ; Xu, S-A. ; Seldon, H. L. ; Franz, B. K-H. G. ; Clark, Graeme M. ( 1992)
    For the safety of cochlear implantation in children under two, the implant assembly must not adversely effect the tissue of compromise head growth. Furthermore, growth changes and tissue responses should not impair functioning of the device. Dummy receiver-stimulators, interconnect plugs and leadwire-lengthening systems have been implanted for periods of 40 months in the young monkey to most effectively model the implantation of the young human child. The results show that implanting a receiver-stimulator package has no effect on skull growth or brain tissue under the package. The system for fixing the electrode at the fossa includes proved effective. There was marked osteoneogenesis in the mastoid cavity and this also resulted in fixation of the leadwire outside the cochlea. This study provides evidence for the safety of cochlear implantation in young children.
  • Item
    Thumbnail Image
    Cochlear implantation in young children: long-term effects of implantation on the skull and underlying central nervous system tissues in a primate model [Abstract]
    Burton, Martin J. ; Shepherd, R. K. ; Xu, S-A. ; Clark, Graeme M. ( 1992)
    Recent independent studies reporting results obtained by profoundly deaf children implanted with the Melbourne 22-channel cochlear implant have provided further impetus for assessing the feasibility of implanting children under two. Studies in appropriate animal models must first establish the safety of this procedure.