Graeme Clark Collection
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ItemThe development of a tympanic membrane sensor for a totally implantable cochlear implant or hearing aid(Monduzzi Editore, 1997)We present the design and development of a tympanic membrane sensor for a totally implantable cochlear implant or hearing aid system. The sensor employs a fiber-optic lever which is hermetically sealed in a biocompatible cartridge and implanted in the middle ear cavity. The sensor prototype has been designed, constructed and tested in cats. In addition, the implantation procedure of the device has also been studied using human temporal bones.
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ItemPeri-modiolar electrode arrays: a comparison of electrode position n the human temporal bone(Monduzzi Editore, 1997)This paper describes a radiologic evaluation of three types of peri-modiolar arrays, comparing their trajectory within the scala tympani with a standard Mini-22 electrode. All peri-modiolar arrays were found to lie closer to the modiolus for much of their insertion length compared with the standard array. While one design showed evidence for the potential of increased insertion trauma, two designs produced satisfactory results. Although further electrode development, temporal bone and histopathologic studies arE required, it would appear that the benefits of peri-modiolar electrode arrays will be realised clinically.
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ItemSiting the receiver-stimulator of the CI-24M model of the Cochlear Limited multiple-channel cochlear implant and fixation of its electrode array(Monduzzi Editore, 1997)The correct siting of the cochlear implant receiver-stimulator package is important. The package should not obtrude significantly above the surface of bone, and should be so that blows to the head do not in damage to the package, skull or brain. The cochlear implant electrode array must be fixed at a site close to the cochlea, so that the electrode will not slide out, or be subject to differential movement with growth changes. Fixation, with Dacron® mesh, platinum-iridium ties, or clips, has been in the region of the posterior root of the zygoma and the floor of the antrum. Our research studies demonstrate that a specially-designed collar around the array can be placed through the cochleostomy and provide the necessary locking to prevent retraction of the array. It has a ceramic surround to encourage union with neighbouring bone, and stress relief to reduce wire fracture at the point where the array leaves the cochlea.
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ItemMulticenter evaluations of speech perception in adults and children with the nucleus (cochlear) 22-channel cochlear implant(Kugler, 1996)The Nucleus 22-channel cochlear implant has been implanted in over 10,500 patients in 79 countries. and used for more than 25 languages. It arose as a result of our early physiological, behavioral and biological research on experimental animals. The historical development of the Nucleus device has been outlined in detail by Clark. Our ongoing research has led to improvements in the way speech is processed with the 22-channel device that are now resulting in improved speech perception for profoundly totally deaf people that is, on average, better than the speech perception obtained by many deaf people with hearing aids. The multiple-channel cochlear implant was first approved by the US Food and Drug Administration (FDA) for use in postlinguistically deaf adults in 1985. It was subsequently approved for use in children in 1990. The proportion of children (18 years of age and under) to have now received it is approximately 439C (4,500 out of 10.500). In evaluating improvements in speech processing it is important to design well-controlled studies, and a number of important ones which have previously been published are summarized in this paper. In addition, speech perception results for all the Nucleus speech processing strategies have been obtained four to six months postoperatively from unselected patients presenting to the Cochlear Implant Clinic at the Royal Victorian Eye & Ear Hospital (RVEEH), Melbourne, and are presented in this paper. As results can vary greatly with different durations of experience it is essential to make comparisons at the same time postoperatively. These clinical data are the most complete to date for comparing the Nucleus speech processing strategies.
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ItemHistopathology following electrode insertion and chronic electrical stimulation(Raven Press, 1985)We have examined a number of safety issues associated with cochlear implants. This work has been primarily designed to evaluate the histopathological effects of intracochlear electrode implantation and chronic electrical stimulation. The results of these studies may be summarized as follows: 1) The insertion of the banded free-fit scala tympani array into human cadaver temporal bones produces minimal damage, occurring primarily to a localized region of the spiral ligament. This damage would not result in significant neural degeneration and thus, would not compromise the efficacy of the multiple channel device; 2) chronic intracochlear electrical stimulation for continuous periods of 500 to 2000 hours, using charge balanced biphasic current pulses developing charge densities of 18-32 }?C/cm2. geom./phase, does not adversely affect the spiral ganglion cell population; 3) labyrinthine infection severely reduces the viable spiral ganglion cell population; 4) the formation of new bone present in approximately half of the animals we have implanted --is not associated with electrical stimulation per se; 5) scanning electron microscope studies of electrodes subjected to long periods of intracochlear electrical stimulation reveals minimal platinum dissolution when compared with unstimulated control electrodes, and electrodes that have been stimulated for similar periods in inorganic saline.
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ItemSelection of patients for multiple-channel cochlear implantation(Raven Press, 1985)Only profoundly, bilaterally deaf adults are considered for evaluation. It is necessary to determine that the patient's communication ability cannot be improved to any significant degree with conventional hearing aids currently available. Initial assessment consists of audiometry, hearing aid evaluation(s), otological and medical examination, and for patients with no recent experience with hearing aids, a hearing aid trial. Polytome x-rays of temporal bones is carried out to ensure that cochlea structures are not grossly abnormal. Electrical stimulation of the promontory is used to confirm the presence of residual auditory nerve fibers. Where there is an audiometric difference between ears, the poorer ear is chosen for implantation provided there are no other contraindications. Intensive counselling is carried out to enable patients to make a fully informed decision about implantation. Patients undergo a battery of speech discrimination and lipreading tests with their hearing aid after their hearing aid trial. This is to provide a baseline for comparison with postoperative results and to assess the benefit obtained from the hearing aid. Any significant improvement in test results when using a hearing aid over lipreading alone would be a contraindication for implantation. Medical assessment is carried out as for any major surgery, including pathology, respiratory function tests and cardiovascular assessment. Particular emphasis is placed on infection prevention immediately preoperatively and during surgery.