Graeme Clark Collection
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ItemExpandable leadwires for a paediatric cochlear implant [Abstract]( 1993)Anatomic studies of skull growth have shown an increase (about 20 mm) in the distance between the round window and the asterion where the receiver-stimulator is usually located. In order to accommodate the skull growth of young patients, an expandable leadwire connecting the receiver-stimulator and the electrode array is necessary. Several expandable leadwires were evaluated in experimental animals, including helical leadwires protected by Silastic tubes and leadwires, with "V" or "W"-shaped levels in a single phase, and protected by thin Silastic or Teflon bags. The leadwires together with their controls were implanted on young animal's scapulae, temporal and parietal bones and in subcutaneous tissue. The in vivo expansion of the leadwire was monitored by periodic x-ray examination and the force to expand the leadwire was measured at the completion of implantation. The results showed that helical leadwires weresurrounded by fibrous tissue and a large force was required to expand them. The V or W-shaped leadwires were able to expand up to 20 mm in vivo and only a moderate force was required to expand them. For most of the cases, there was none or little fibrous tissue in Silastic or Teflon bags. The results indicated that for a paediatric cochlear implant, leadwires with V or W-shaped levels could, expand and biocompatible envelopes could effectively protect the leadwires from being bound by fibrous tissue.
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ItemPaediatric cochlear implantation: radiological and histopathological studies of skull growth in the monkey( 1993)The human skull undergoes significant growth within the first two years of life (Dahm et aI, 1992). Therefore, before children under two can be considered candidates for cochlear implantation, the effects of the surgical procedure on subsequent skull growth must be well understood. To evaluate the effects of implantation on skull growth four macaque monkeys were implanted with dummy cochlear implants at six months of age. To model the procedure in the very young child, the bed for the receiver-stimulator was drilled across a calvarial suture down to the underlying dura and an electrode array inserted into the scala tympani via a mastoidectomy and posterior,tympanotomy. Plain skull radiographs were perioqical1y taken to monitor skull growth for periods of up to three years following implantation. Their longitudinal measurements revealed no evidence of asymmetrical skull growth when compared with unimplanted control animals. Computer tomographic scans taken at post-mortem confirmed these findings. Finally, subsequent histopathological evaluation of the receiver-stimulator package bed indicated that it becomes obliterated by hard tissue, resulting in a localized flattening of the vault under the receiver-stimulator. However, this tissue exhibited histological evidence of sutures, indicating that the surgical procedure should not lead to premature sutural closure. In conclusion, the present experimental results suggest that long-term cochlear implantation in very young children will not lead to any significant skull deformity.
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ItemThe effect of inflammation on blood vessel area as a cause of variation in ganglion cell density measurements in the cat cochlea [Abstract]( 1992)The success of a cochlear implant depends on an adequate number of surviving spiral ganglion cells. Further loss of ganglion cells may arise from the biology of cochlear implantation itself. The quantitative analysis of ganglion cells is, therefore, an important consideration when assessing the biological safety of a cochlear implant.
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ItemMultichannel cochlear implants in children: an overview of experimental and clinical results at the University of Melbourne [Opening Lecture]( 1992)During the last decade there has been great progress in the clinical management of profound, postlinguistically deafened adults through the use of multichannel cochlear implants. The device developed by The University of Melbourne in association with Cochlear Pty Ltd, electrically stimulates selective regions of the auditory nerve using an array of 22 platinum (Pt) electrodes located in the scala tympani. Its development followed basic experimental studies and the development and evaluation of a prototype device in the 1970's. Following safety studies and a successful clinical trial, the Melbourne/Cochlear multichannel implant was approved for use in adults by the United States Food and Drug Administration (FDA) in 1985. More than 3000 patients throughout the world have since been implanted with this device, many being able to understand a significant amount of unfamiliar, connected speech without lipreading Following miniaturization of the implant, it became suitable for use with children. In 1990, after additional biological safety and clinical investigations, the FDA approved the use of the Melbourne/Cochlear multichannel implant for profoundly deaf children above the age of two years. And in 1991, the device received the medical device implantation approval certificate from the Japanese Government. The present paper presents an overview of our recent biological safety studies and clinical experience in children, and discusses the likely future development of these devices.
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ItemCochlear implantation in young children: long-term effects of implantation on normal hair cells and spiral ganglion cells in the monkey model [Abstract]( 1992)Recent independent results obtained by profoundly deaf children implanted with the Melbourne 22-channel cochlear implant (1) have provided further impetus. for examining thefeasibility of implanting children under two and children with profound deafness. Safety st1,ldies, in appropriate animal models, must first establish the safety of this procedure.