Graeme Clark Collection
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ItemA protocol for the prevention of infection in cochlear implant surgery(Cambridge University Press, 1980)The reduction of infection to an absolute minimum is a very desirable goal in any form of surgery. It is especially important with a cochlear implant operation as infection in the labyrinth can lead to degeneration of the auditory nerve fibres it is hoped to stimulate electrically (Clark et al, 1975). Furthermore, as the implantation of foreign materials increases the risk of infection, as the operation can last 6-7 hours (Altemeier et al., 1976), and as the operators are in very close proximity to the implant site, more stringent measures for the prevention of infection need to be adopted than with other forms of otological surgery. For these reasons a protocol has been developed for preventing infection in our cochlear implant surgery. This is an overall approach to the prevention of infection and involves pre-operative measures, an operating theatre routine, the use of horizontal laminar flow filter units, correct surgical technique and the use of systemic and local antibiotics.
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ItemThe biologic safety of the Cochlear Corporation multiple-electrode intracochlear implant( 1988)Studies have been undertaken to confirm the biologic safety of the Cochlear Corporation multi-electrode intracochlear implant. The materials used are biocompatible. The electrode array is flexible: it can be inserted with minimal or no trauma, providing the insertion is stopped when resistance is first felt. An atraumatic insertion is facilitated if a good view is obtained along the scala tympani of the basal turn of the cochlea by drilling through the crista fenestrae. The passage of the electrode around the cochlea can be facilitated if the electrode is rotated during insertion (clockwise for the left and anticlockwise for the right cochlea). The electrode can be explanted and another one reinserted with minimal or no trauma. A seal established around the electrode after an implantation period of 2 weeks can prevent infection extending from the middle to the inner ear. The electrical stimulus parameters produced by the Nucleus receiver-stimulator cause no loss of spiral ganglion cells or corrosion of the platinum band electrodes. Long-term stimulation has been carried out for up to 8 years in patients without affecting their clinical performance.
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ItemThe histopathology of the human temporal bone and auditory central nervous system following cochlear implantation in a patient: correlation with psychophysics and speech perception results( 1988)Cochlear implantation has become a recognised surgical procedure for the management of a profound-total hearing loss, especially in patients who have previously had hearing before going deaf (postlingual deafness). Nevertheless, it is important for progress in the field that patients who have had a cochlear implant, bequeath their temporal bones for research. This will then make it possible to further assess the safety of the procedure, and the factors that are important for its effectiveness. Biological safety has been assessed in a number of studies on animals, in particular, the biocompatibility of the materials used (1,2), the histopathological effects of long-term implantation on the cochlea (3, 4, 5, 6, 7, 8), and the effects of chronic electrical stimulation on the viability of spiral ganglion cells (9, 10, 11, 12). In studying the temporal bones of deceased cochlear implant patients it is possible to help establish that the animal experimental results are applicable to Man. Surgical trauma has been most frequently evaluated by inserting electrodes into cadaver temporal bones. It is important, however, to examine bones that have been previously implanted surgically to ensure that the cadaver findings are applicable to operations on patients. The effectiveness of cochlear implantation can be studied by correlating the histopathological findings, the dendrite and spiral ganglion cell densities, in particular, with the psychophysical and speech perception results. Other benefits also accrue, for example, establishing the accuracy of preoperative X-rays and electrical stimulation of the promontory in predicting cochlear pathology and spiral ganglion cell numbers. For the above reasons it has been especially interesting to examine both the temporal bones and central nervous system from one of our patients (patient 13) who participated in the initial clinical trial of the Cochlear Proprietary Limited (a member of the Nucleus group) multiple-electrode cochlear prosthesis, and who died due to a myocardial infarction following coronary bypass surgery.
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ItemThe University of Melbourne/Nucleus cochlear prosthesis( 1988)This is a review of research to develop the University of Melbourne/Nucleus cochlear prosthesis for patients with a profound-total hearing loss. A more complete review can be obtained in Clark et al. A prototype receiver-stimulator and multiple-electrode array developed at the University of Melbourne was first implanted in a postlingually deaf adult patient with a profound-total hearing loss on 1 August 1978. A speech processing strategy which could help this patient understand running speech, especially when combined with lipreading was developed in 1978 following initial psychophysical studies. A prototype wearable speech processor was fabricated in 1979, that could provide significant help for the first two patients in understanding running speech when used in combination with lipreading compared with lipreading alone, and it also enabled them to understand some running speech when using electrical stimulation alone. An implantable receiver-stimulator and wearable speech processor embodying the principles of the prototype devices were then produced for clinical trial by the Australian biomedical firm, Nucleus Ltd, and its subsidiaries, Cochlear Pty Ltd and Cochlear Corporation. This cochlear implant was initially clinically trialled on six patients at The Royal Victorian Eye & Ear Hospital in 1982, and shown to give similar results to those obtained with the prototype device. In view of these findings a clinical trial was carried out for a Premarket Approval Application to the US Food and Drug Administration (FDA), and extended to a number of centres in the US, Canada, and West Germany. This clinical trial confirmed that patients could understand running speech when electrical stimulation was combined with lipreading, and that some patients could also understand running speech when using electrical stimulation alone. Today, more than 600 patients world-wide are using cochlear implants developed from the research described in this paper.
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ItemSurgery for the safe insertion and reinsertion of the banded electrode array( 1987)Adhering to the surgical technique outlined in the protocol for the Nucleus implant has resulted in over 100 patients worldwide obtaining significant benefit from multichannel stimulation. A detailed analysis of the results in 40 patients shows that it improves their awareness of environmental sounds and their abilities in understanding running speech when combined with lipreading. In addition, one third to one half of the patients also understand significant amounts of running speech without lipreading and some can have interactive conversations over the telephone. It is clear that any insertion trauma is not significant, which is confirmed by the excellent clinical results.
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ItemPreliminary results for the Cochlear Corporation multielectrode intracochlear implant in six prelingually deaf patients( 1987)The preliminary results from this study indicate that some prelingually deaf patients may get worthwhile help from a multiple-electrode cochlear implant that uses a formant-based speech processing strategy. It is encouraging that these improvements can occur in young adults and teenagers. The results for two children are also encouraging. A 10-year-old child obtained significant improvement on some speech perception tests. It was easy to set thresholds and comfortable listening levels on a 5-year-old child, and he is now a regular user of the device. There are, however, considerable variations in performance among the prelingual patients, which may be related to the following factors: whether they have had some hearing after birth, the method of education used, the motivation of the patient, and age at implantation.
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ItemA multiple-electrode intracochlear implant for children( 1987)A multiple-electrode intracochlear implant that provides 21 stimulus channels has been designed for use in young children. It is smaller than the adult version and has magnets to facilitate the attachment of the headset. It has been implanted in two children aged 5 and 10 years. The two children both lost hearing in their third year, when they were still learning language. Following implantation, it was possible to determine threshold and comfortable listening levels for each electrode pair. This was facilitated in the younger child by prior training in scaling visual and electrotactile stimuli. Both children are regular users of the implant, and a training and assessment program has been commenced.
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ItemBanded intracochlear electrode array: evaluation of insertion trauma in human temporal bones( 1985)A banded free-fit scala tympani array was inserted into a basal turn of nine human cochleas to evaluate the trauma produced by the procedure. These nine cochleas, together with five nonimplanted controls, were serially sectioned and examined microscopically for damage to the membranous labyrinth, in particular the spiral ligament, the basilar and Reissner’s membranes, the stria vascularis, and the osseous spiral lamina. The severity and location of any trauma along the cochlear spiral were recorded. The results indicate that the insertion of the banded scala tympani array resulted in minimal mechanical damage, occurring primarily to a localized region of the spiral ligament. This would not result in significant neural degeneration, and therefore would not compromise the efficacy of multichannel cochlear prosthesis.
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ItemThe multi-channel cochlear implant( 1984/85)The multi-channel cochlear implant codes sounds on the bases of rate and place pitch. Experimental studies on animals and patients have shown it is difficult for electrical stimulation to code rate pitch above about 200-400 pulses/second. Therefore to convey as much information about speech as possible it is necessary to produce multi-channel stimulation or place pitch so that the important frequency cues in vowels and consonants can be perceived by the patient.
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ItemImplanted material tolerance studies for a multiple-channel cochlear prosthesis( 1984)We have performed a number of temporal bone and animal studies in order to evaluate the histopathological effects of intracochlear electrode implantation and chronic electrical stimulation. Our results indicate that (a) the insertion of a free-fit scala tympani array results in minimal damage to the membranous labyrinth; (b) the materials used in the electrode array evoke mild tissue reactions when implanted subcutaneously, in muscle, or within the scala tympani; (c) intracochlear electrical stimulation for periods of 500 to 2000 hours, using carefully controlled biphasic pulses, does not adversely affect the population or neural activity of the primary auditory neurones; (d) labyrinthine infection severely reduces the number of viable spiral ganglion cells; (e) an adequate fibrous tissue seal of the round window can prevent the spread of infection from the bulla to the implanted cochlea in cats, following inoculation of the bulla cavity with bacteria; (f) bone growth is not associated with electrical stimulation per se; (g) the electrode arrays show minimal platinum dissolution and no apparent degradation of the Silastic® carrier following periods of long-term intracochlear electrical stimulation.