Graeme Clark Collection

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    A multiple-electrode intracochlear implant for children
    Clark, Graeme M. ; Blamey, Peter J. ; Busby, Peter A. ; Dowell, Richard C. ; Franz, Burkhard K-H. ; Musgrave, Gaye Nicholls ; Nienhuys, Terry G. ; Pyman, Brian C. ; Roberts, Susan A. ; Tong, Yit C. ; Webb, Robert L. ; Kuzma, Januz A. ; Money, David K. ; Patrick, James F. ; Seligman, Peter M. ( 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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    Banded intracochlear electrode array: evaluation of insertion trauma in human temporal bones
    Shepherd, R. K. ; Clark, Graeme M. ; Pyman, B. C. ; Webb, R. L. ( 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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    The histopathological effects of chronic electrical stimulation of the cat cochlea
    Shepherd, R. K. ; Clark, Graeme M. ; Black, R. C. ; Patrick, J. F. (Cambridge University Press, 1983)
    The success of a cochlear implant depends on stimulating an adequate number of viable spiral ganglion cells. The effect of chronic electrical stimulation on ganglion cells is therefore an important consideration when assessing the effectiveness and safety of such a device. The histopathological assessment of chronic unstimulated intracochlear electrodes is now well documented (Simmons, 1967; Clark, 1973; Clark et al, 1975; Schindler and Merzenich, 1974; Schindler, 1976; Schindler et al, 1977; Sutton et al, 1980). These experimental studies have used a variety of electrode designs, materials and surgical techniques. However, all have shown that chronic implantation has little effect on the peripheral nerves and the spiral ganglion cells adjacent to an implant, provided the insertion procedure is free of trauma and infection.
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    Chronic electrical stimulation of the auditory nerve in cats: physiological and histopathological results
    Shepherd, R. K. ; Clark, Graeme M. ; Black, R. C. ( 1983)
    The ability of spiral ganglion cells to survive long-term electrical stimulation is a precondition for the success of cochlear prostheses. In this study 10 cats were implanted bilaterally with bipolar scala tympani electrodes and stimulated for periods of up to 2029 hours using charge balanced biphasic current pulses. The status of the auditory nerve was monitored periodically by recording electrically evoked auditory brainstem responses. At the conclusion of the stimulation program, spiral ganglion cell survival was assessed for stimulated and control cochleas; comparison of the two groups showed no statistically significant difference. The results of this study indicate that long-term intracochlear electrical stimulation using carefully controlled biphasic pulses does not adversely affect the spiral ganglion cell population.
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    Design and fabrication of the banded electrode array
    Clark, Graeme M. ; Shepherd, R. K. ; Patrick, James F. ; Black, R. C. ; Tong, Y. C. ( 1983)
    A multiple-channel electrode array must meet certain design requirements; these are listed in TABLE 1. First, there should be no trauma associated with the surgical insertion, and if there is a need to replace the array, this procedure should also be atraumatic. Second, it should be biologically inert. This means that it should be biocompatible with the tissues. When placed in the cochlea, the array should also not predispose the patient to local infection, and this is particularly important in children, in whom recurrent middle ear infections could spread to the inner ear. There should also be no risk of carcinogenicity with long-term implantation. Third, the electrode array should be designed so that the stimulus current can be localized to discrete groups of nerve fibers, and it should also be possible to stimulate as many groups as possible from the total remaining nerve population. Fourth, with long-term stimulation, there should be no significant corrosion of the electrodes used, and the electrical stimulation should not lead to damage of the tissues in the cochlea, especially the residual nerve fibers. Fifth, the electrode array should be mechanically robust and stable. It should not be prone to break as a result of repeated stress by the acceleration of the head during everyday movements. The array should also be capable of being fixed in place so that it will not shift its position. Sixth, it is desirable that the means of fabrication of the multiple-channel array should be simple and inexpensive. (From Introduction)
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    Histopathology following electrode insertion and chronic electrical stimulation
    Shepherd, R. K. ; Clark, Graeme M. ; Pyman, B. C. ; Webb, R. L. ; Murray, M. T. ; Houghton, M. E. (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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    Chronic electrical stimulation of the auditory nerve in cats
    Shepherd, R. K. ; Clark, Graeme M. ; Black, R. C. ; Patrick, J. F. ( 1982)
    One requirement for the success of a cochlear hearing prosthesis is that long-term electrical stimulation must not have adverse effects on the residual spiral ganglion cell population. Electrochemically 'safe' stimulation regimes have been defined for the cortex (Brummer &Turner, 1977). However, few investigators have examined the effects of long-term intracochlear electrical stimulation. Walsh et al (1980), stimulating with current densities greater than the 'safe' limits defined by Brummer &Turner (1977), for periods of up to 800 hours at current levels of 4.0-8.0 mA, recorded slight local neural degeneration adjacent to the electrodes.