Graeme Clark Collection
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ItemImplantation of the Melbourne/Cochlear multiple-electrode extracochlear prosthesis(Annals Publishing Co., 1989)The Melbourne/Cochlear multiple-electrode extracochlear implant is designed for deaf patients who are unsuited to multiple-electrode intracochlear implantation. The implant consists of a receiver-stimulator package connected via a lead wire assembly to six individual stimulating electrodes. There is a choice of two alternative surgical procedures, both of which are via a combined middle ear approach using anterior and posterior tympanotomies. Four active electrodes shaped into compressible platinum-iridium soft-balls are fed through the mastoid cavity and across the facial recess, and placed into cavities that are made over the cochlear turns that project to the medial wall of the middle ear. One hard-ball active electrode is placed into the round window niche. One hard-ball reference electrode is placed into the hypotympanum. An additional electrode wrapped around the lead wire assembly can be used as an alternative reference electrode. A specially designed insertion needle facilitates the placement and the fixation of the soft-ball electrodes.
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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 surgical anatomy for multiple-electrode extracochlear implant operations(Cambridge University Press, 1988)Direct access to the whole length of the cochlear turns via endaural middle ear approach for the placement of extracochlear electrodes is severely restricted. Approximately 10 mm. of the cochlear turns are accessible, being less than a third of their length. The middle cranial fossa, the facial nerve, the internal carotid artery and the temporomandibular joint restrict the access. A further restriction is caused by the position of the cochlea and the direction of its axis. The anterior part of the cochlea lies anterior to the tympanic membrane and medial to the temporomandibular joint, thus limiting an endaural approach to a posterolateral direction. Despite this limitation small sections of the basal, middle and apical turns of the cochlea can be reached.
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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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ItemRecent developments with the Nucleus 22-electrode cochlear implant: a new two formant speech coding strategy and its performance in background noise( 1987)A clinical evaluation of speech processing strategies for the Nucleus 22-electrode cochlear implant showed improvements in understanding speech using the new F0F1F2 speech coding strategy instead of the F0F2 strategy. Significant improvement in closed-set speech recognition in the presence of background noise was an additional advantage of the new speech processing strategy.
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ItemSurgical anatomy of the round window with special reference to cochlear implantation(Cambridge University Press, 1987)When the multi-channel cochlear implant electrode is inserted into the scala tympani through the round window the operation is best performed via a posterior tympanotomy. The view of the round window membrane, however, is incomplete because of its orientation and the fact that it has a conical shape. Nevertheless, a good view along the basal turn is obtained after the antero-inferior overhang of the round window niche and the crista fenestrae have been removed. It might be damaging to drill away the postero-superior overhang as the osseous spiral lamina lies extremely close to the round window membrane.
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ItemEffect of experimentally induced otitis media on cochlear implants( 1987)Cat cochleas implanted with scala tympani prostheses were investigated histologically after inoculating the bullae with a suspension of group A streptococci. The prosthesis was passed through the round window membrane in one ear. In the other the prosthesis bypassed the round window via an opening anteroinferior to the round window niche. Before death, horseradish peroxidase was administered as a tracer for possible pathways of infection. Results showed that group A streptococci were pathogenic to the cat and caused inflammation in the bulla. The unimplanted round window membrane and the seals around the electrode entry points prevented infection from entering the cochlea. The seals around electrodes inserted either through the round window membrane or an opening drilled anteroinferior to the niche were equally effective. The horseradish peroxidase tracer studies showed, however, that a gap existed between the electrode and membranous seal, and this could be a potentially vulnerable site under certain conditions. Drilling an anteroinferior opening into the cochlea resulted in bony sequestra entering the cochlea. This can be avoided by blue-lining the opening and removing bone with picks before making an opening through the endosteum.
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ItemRefined surgical technique for insertion of banded electrode array( 1987)A refined electrode insertion technique is presented for the multichannel cochlear implant. It comprises two basic steps. The first step is the removal of the anteroinferior overhang of the round window and crista fenestrae, or alternatively an opening drilled into the scala tympani anteroinferior to the round window. The second is rotation of the electrode during insertion, counterclockwise in the right ear and clockwise in the left ear.
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ItemMiddle ear infection postimplantation: response of the round window membrane to Streptococcus pyogenes( 1987)The seal of the implanted round window membrane to resist Streptococcus pyogenes invasion from the middle ear was investigated in 12 cats. Results showed that the implanted round window membrane is able to form a barrier for S pyogenes starting 1 week postimplantation. Under normal conditions S pyogenes did not pass through the round window membrane, nor through the gap that existed between the membrane and the prosthesis. Mechanical disruption of the round window seal, however, and severe inflammatory response to S pyogenes caused the infection to extend into the inner ear.