Graeme Clark Collection
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ItemCochlear implants in children: the value of cochleostomy seals in the prevention of labyrinthitis following pneumococcal otitis media( 1995)Cochlea implantation at an early age is important in rehabilitating profoundly hearing impaired children. Given the incidence of pneumococcal otitis media in young children, there has been concern that cochlear implantation could increase the possibility of otitis media, leading to labyrinthitis in this age group. Clinical experience has not indicated an increase in the frequency of otitis media and labyrinthitis in implanted adults or children over two years. However, labyrinthitis has occurred in implanted animals with otitis media. In order to assess the impact of cochlear implants on the occurrence of labyrinthitis, pneumococcal otitis media was induced in 21 kittens. Thirty-two kitten cochleas were implanted, of which 9 had a fascial graft and 9 a Gelfoam® graft. Nine control cochleas were unimplanted. Labyrinthitis occurred in 44% of unimplanted controls. 50% of implanted ungrafted cochleas, and 6% of implanted grafted cochleas. There was no statistically significant difference between the incidence of labyrinthitis in the implanted cochleas and the unimplanted controls. However there was a statistically significant difference between the ungrafted and grafted cochleas, but not between the two types of graft.
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ItemCochlear implantation in young children: histological studies on head growth, leadwire design, and electrode fixation in the monkey model( 1994)For safe cochlear implantation in children under 2 years of age, the implant assembly must not adversely affect adjacent tissues or compromise head growth. Furthermore, growth changes and tissue responses should not impair the function of the device. Dummy receiver-stimulators, interconnect plugs, and leadwire-lengthening systems were implanted for periods of 36 months in the young monkey to effectively model the implantation of the young child. The results show that implanting a receiver-stimulator package has no adverse effects on skull growth or the underlying central nervous system. The system for fixing the electrode at the fossa incudis proved effective. There was marked osteoneogenesis in the mastoid cavity, resulting in the fixation of the leadwire outside the cochlea. This study provides evidence for the safety of cochlear implantation in young subjects.
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ItemAnimal models of human disease: otitis media( 1991)Otitis media is an inflammation of the middle ear, which may or may not be of microbial origin. Genetic, immunologic, allergic conditions, antecedent viral respiratory infections, and mastoid size are contributing factors for middle ear disease. Dysfunction of the eustachian tube predisposes to acute otitis media. Collection of fluid within the middle ear cavity is part of the disease process and is equally observed in infectious and noninfectious middle ear disease. Streptococcus pneumonia, Haemophilus influenza, Streptococcus pyogenes, and Streptococcus aureus are the most common organisms that cause acute infectious otitis media.
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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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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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ItemCochlear implant and otitis media: a pilot study to assess the feasibility of pseudomonas aeruginosa and streptococcus pneumoniae infection in the cat( 1984/85)An experimental model for the induction of otitis media in cats is described using pseudomonas aeruginosa and streptococcus pneumoniae. Until now the cat has been regarded as being resistant to streptococcus pneumoniae infections, whereas pseudomonas aeruginosa is known to cause a most virulent otitis media in this animal. A successful inoculation using streptococcus pneumoniae, however, can be achieved by direct inoculation of a highly concentrated suspension of microorganisms in the bulla, retention of the organisms by Gelfoam®, and enhancement of virulence by intrapertioneal inoculation in mice. The model promises to be an important contribution in studying the effects of pneumococcal otitis media in Cochlear Implants.
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ItemCochlear implantation in children: the risk of pneumococcal otitis media [Abstract]( 1992)Pneumococcal otitis media is most frequent in young children and is a matter of concern in cochlear implantation. In the course of the 'implantation surgery the physiological barrier between the middle ear and inner ear is broken down by incising the round window membrane or by fenestration of the cochlear wall. It is feared that the insertion of an electrode array into the scala tympani could provide a pathway for microorganisms and toxins to enter the cochlea, resulting in labyrinthitis. To assess the actual risk of, secondary inner ear infection post implantation we developed a cat animal model of otitis media. In addition we examined the, effectiveness of different sealing strategies compared to the alternative of leaving the electrode entry point unprotected. For sealing of the cochlea fibrous tissue or gelatine foam was wrapped around the electrode in the round window niche. 22 kittens (44 ears) were used for this study 32, ears were implanted at 2 months of age, and all 44 ears were inoculated after 2 months with a broth of, streptococcus pneumoniae and the animals sacrificed one week later. The bullae of the animals were swabbed and the cochleas processed and examined under light microscopy. Histological analysis of the cochleas showed ,the� highest incidence (45%) of labyrinthine spread of infection in the unimplanted control group. Suppurative or serous labyrinthitis was found in only one third (33.3%) of the implanted and unsealed cochleas. In contrast only one of 16 sealed cochleas, (6.2 %) showed labyrinthine signs of acute inflammation. Experimental pneumococcal otitis media could be reliably established in all animals and proved to be a valuable animal model for the testing of the intracochlear spread of infection. We conclude that a cochlear implant electrode inserted via the round window does not increase the risk of tympanogenic abyrinthitis. Our results indicate that grafting of the electrode entry point results in significant protection of the inner ear against labyrinthine spread of ototis media along the leadwire of the cochlear implant.
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ItemCochlear implantation in young children: studies on head growth, leadwire design and electrode fixation in the monkey model [Abstract]( 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.
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ItemCochlear implant safety studies [Abstract]( 1991)We have examined a number of safety issues associated with cochlear implantation in both adults and children and confirm that it is safe. The results of these studies may be summarized as follows: 1) The insertion of a free-fit scala tympani array into the human cochlea produces minimal damage to cochlear structures provided insertion is stopped at the point of first resistance. 2) Chronic intracochlear implantation and electrical stimulation using charge balanced biphasic current pulses does not result in neural degeneration or evoke an adverse tissue reaction within the cochlea. 3) The use of fascia to seal the implanted round window results in an effective barrier to the spread of infection into the cochlea. 4) Temporal bone studies have shown that the distance between the round window and the fossa incudis remains essentially unchanged from birth. Therefore, the fossa incudis provides a suitable fixation point for the electrode array in young children. This study also showed that the distance from the round window to the implanted receiver-stimulator undergoes significant change in children of up to two years of age. These children would require an expanding leadwire system. 5) Finally, long-term effects of cochlear implant surgery on skull growth have shown that this should not be a problem when implanting very young children. This work was supported by the NIH (NOI-NS-7-2342).