Graeme Clark Collection

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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.