Elaine Saunders

Threshold, comfortable level and impedance changes as a function of electrode-modiolar distance.

Objective The study investigated the hypothesis that threshold and comfortable levels recorded from cochlear implant patients would reduce, and dynamic range increase, as distance of the electrode from the modiolar wall (radial distance) decreases. Two groups of cochlear implant patients participated; one group using the Nucleus® 24 Contour™ electrode array, and one group using the Nucleus standard straight (banded) array. The Nucleus 24 Contour array has been shown in temporal bone studies to lie closer to the modiolus than the banded array. The relationship of electrode impedance and radial distance is also investigated. Design The study, conducted at three centers, evaluated 21 patients using the Contour array, and 36 patients using the banded array. For each patient, threshold, comfortable levels and dynamic range were measured at four time points. Common ground electrode impedance was recorded clinically from each patient, at time intervals up to 12 wk. An estimate of the radial distance of the electrode from the modiolus was made by analysis of Cochlear view x-rays. Results Threshold and comfortable levels were significantly lower for the Nucleus 24 Contour array than for the banded array. However, dynamic range measurements did not show the predicted increase. In a majority of subjects, a significant correlation was found between the estimated radial distance of the electrode from the modiolus and the measured threshold and comfortable levels. This trend was not observed for dynamic range. The analysis indicates that other factors than radial distance are involved in the resultant psychophysical levels. Clinical impedance measures (common ground) were found to be significantly higher for the Contour array. However, the electrodes on the Contour array are half-rings, which are approximately only half the geometric size of the full rings as electrodes of the standard array. When the geometric electrode area in the two array designs are normalized, the trends in the electrode impedance behavior are similar. Conclusions The results support the hypothesis that the relationship between the radial distance of the electrode and the psychophysical measures are influenced by patterns of fibrous tissue growth and individual patient differences, such as etiology and neural survival. Impedance measures for the Nucleus 24 Contour electrode array were higher than the banded electrode array, but this is primarily due to the reduction in electrode surface area. The different outcomes in impedance over time suggest differences in the relative contributions of the components of impedance with the two arrays.

The contour electrode array: safety study and initial patient trials of a new perimodiolar design.

Objective The aim of these studies was to investigate the insertion properties and safety of a new intracochlear perimodiolar electrode array design (Contour). Background An electrode array positioned close to the neural elements could be expected to reduce stimulation thresholds and might potentially reduce channel interaction. Methods Two sequential studies were conducted. In study 1, the Contour electrode array was inserted in 12 human temporal bones. After cochlear surface preparation, the position of the array was noted and the basilar membrane was examined for insertion damage. On the basis of the outcome of this temporal bone study, study 2 investigated the Contour array, mounted on a Nucleus CI-24 M device and implanted in three adult patients. Results Study 1 showed that in 10 temporal bones, the Contour array was positioned close to the modiolus, and the basilar membrane was intact. In the two remaining bones, the arrays had pierced the basilar membrane and were positioned in the scala vestibuli apical to the penetration. Statistical analysis showed an equivalent probability of insertion-induced damage of the two array designs. In study 2, image analysis indicated that the Contour electrodes were positioned closer to the modiolus than the standard Nucleus straight array. Lower T and C levels, but higher impedance values, were recorded from electrodes close to the modiolus. Initial speech perception data showed that all patients gained useful open-set speech perception, two patients achieving scores of 100% on sentence material 3 months postoperatively. Conclusions The temporal bone studies showed the Contour electrode array to be generally positioned closer to the modiolus than the standard Nucleus straight array, and to have an equivalent probability of causing insertion-induced damage.

Psychophysics of a prototype peri-modiolar cochlear implant electrode array.

Psychophysical measurements were performed in three hearing-impaired adult subjects implanted with a CI22 cochlear prosthesis (Cochlear Ltd.) fitted with a developmental peri-modiolar electrode array. The array was manufactured with a curvature approximating that of the inner wall of the scala tympani but, after straightening and insertion, lay on average about half way between the inner and outer walls of the scala. All subjects were tested with bipolar stimulation; two were also tested with monopolar, employing the most basal electrode as the return. Maximum comfortable level and threshold reduced with decreasing distance of electrode from the modiolus, whereas dynamic range increased. The linearity of the loudness growth function did not vary significantly with electrode position but the function was more non-linear for lower maximum comfortable levels. Current level discrimination, normalized with respect to dynamic range, improved with decreasing distance of electrode from the modiolus in two subjects. Pitch varied regularly with insertion depth of the stimulated electrode for bipolar stimulation in two subjects and also for monopolar stimulation in one subject. Electrode discrimination was enhanced by closeness to the modiolus. Whereas the forward masking patterns for bipolar stimulation of electrodes close to the modiolus had a sharp double-peaked structure, those for monopolar stimulation were flatter and had a single peak.

Surgical implications of perimodiolar cochlear implant electrode design: avoiding intracochlear damage and scala vestibuli insertion

Abstract Objective To review the mechanisms and nature of intracochlear damage associated with cochlear implant electrode array insertion, in particular, the various perimodiolar electrode designs. Make recommendations regarding surgical techniques for the Nucleus Contour electrode to ensure correct position and minimal insertion trauma. Background The potential advantages of increased modiolar proximity of intracochlear multichannel electrode arrays are a reduction in stimulation thresholds, an increase in dynamic range and more localized neural excitation. This may improve speech perception and reduce power consumption. These advantages may be negated if increased intracochlear damage results from the method used to position the electrodes close to the modiolus. Method A review of the University of Melbourne Department of Otolaryngology experience with temporal bone safety studies using the Nucleus standard straight electrode array and a variety of perimodiolar electrode array designs; comparison with temporal bone insertion studies from other centres and postmortem histopathology studies reported in the literature. Review of our initial clinical experience using the Nucleus Contour electrode array. Results The nature of intracochlear damage resulting from electrode insertion trauma ranges from minor, localized, spiral ligament tear to diffuse organ of Corti disruption and osseous spiral lamina fracture. The type of damage depends on the mechanical characteristics of the electrode array, the stiffness, curvature and size of the electrode in relation to the scala, and the surgical technique. The narrow, flexible, straight arrays are the least traumatic. Pre-curved or stiffer arrays are associated with an incidence of basilar membrane perforation. The cochleostomy must be correctly sited in relation to the round window to ensure scala tympani insertion. A cochleostomy anterior to the round window rather than inferior may lead to scala media or scala vestibuli insertion. Conclusion Proximity of electrodes to the modiolus can be achieved without intracochlear damage provided the electrode array is a free fit within the scala, of appropriate size and shape, and accurate scala tympani insertion is performed.

Spatial spread of neural excitation: comparison of compound action potential and forward-masking data in cochlear implant recipients.

The feasibility of using the electrically evoked compound action potential (ECAP), measured with the NRT system (Neural Response Telemetry) and the NRT software (version 2.04), to quantify the longitudinal spread of neural excitation was examined in four subjects fitted with the Nucleus CI24M cochlear implant. The ECAP and psychophysical forward-masking profiles were measured using stimulation on each of three electrodes, in basal, middle and apical positions. Spatial spread profiles derived from the ECAP measure produced broader functions than those derived from the psychophysical measure. These results, together with investigation of the change of ECAP spread pattern with stimulation current, suggest that functions derived from this ‘simple’ method were more influenced by the spread of electric field from excited neuron to electrode array than by breadth of the neural excitation pattern. The recently released NRT version 3.0 permits the masker and probe pulses to be delivered to separate electrodes, thus removing a fundamental limitation of version 2.04. Results from a pilot study, in which this capability was exploited, suggest that the spatial functions from this ‘advanced’ method may provide a better correlation with results from psychophysical forward masking. Sumario Se examino´ la factibilidad de utilizar el potencial de accio´n compuesto evocado ele´ctricamente (ECAP), medido con el sistema de NRT (telemetri´a de respuesta neural) y el software NRT (versio´n 2.04), para cuantificar la propagacio´n longitudinal de la excitacio´n neural en cuatro sujetos con implante Nucleus C124M. Se midio´ el ECAP y los perfiles psicofisiolo´gicos de enmascaramiento antero´grado utilizando estimulacio´n separada en tres electrodos: basal, medio y apical. Los perfiles de propagacio´n espacial derivados de la medicio´n ECAP produjeron funciones ma´s amplias que las derivadas de las mediciones psicofisiolo´gicas. Estos resultados, junto con las investigaciones del cambio en el patro´n de expansio´n del ECAP con la estimulacio´n actual, sugieren que las funciones derivadas de este “sencillo” me´todo estuvieron ma´s influidas por la expansio´n del campo ele´ctrico por neuronas excitadas hacia el electrodo que por la amplitud del patro´n de la excitacio´n neural. La ma´s reciente versio´n 3.0 de NRT permite que los pulsos del enmascarador y la sonda sean enviados a diferentes electrodos y con ello se supera la limitacio´n fundamental de la versio´n 2.04. Los resultados de un estudio piloto en los que se exploto´ esta capacidad, sugieren que las funciones espaciales de este me´todo “avanzado” puede proporcionar una mejor correlacio´n de los resultados del enmascaramiento psicofisiolo´gico antero´grado.

Psychophysical measures in patients fitted with Contour and straight Nucleus electrode arrays.

The objective of this study was to compare the psychophysical performance of patients using the Nucleus Contour electrode array with that of patients using the straight banded-electrode array. In particular, we wished to consider how psychophysical parameters would differ for an electrode array positioned closer to the modiolus, and how this might influence both patient benefits and the design of speech processing strategies. Nine subjects participated in the study: four used the Nucleus straight array and five used the Nucleus Contour electrode array. Radiographic analyses found that the Contour array lay closer to the modiolus, was more deeply inserted and spanned a larger fractional length of the basilar membrane than the straight banded-electrode array. The results were analysed in terms of array type and of the position of the individual electrode band, both distance from the modiolus and longitudinal placement. Mean threshold was lower for the Contour array but maximum comfortable level was similar. Whereas threshold varied significantly with distance of electrode band from the modiolus, maximum comfortable level did not. Pitch varied fairly regularly with longitudinal position of the stimulated electrode, with the exception of one Contour subject. The forward masking profiles, using moderately loud maskers, were narrower for the Contour array, indicative of more localized neural excitation.

The role of radiographic phase-contrast imaging in the development of intracochlear electrode arrays

Objective This study describes the application of a new radiographic imaging modality, phase-contrast radiography, to in vitro human temporal bone imaging and investigates its use in the development of new electrode arrays for cochlear implants. Background The development of perimodiolar electrode arrays for cochlear implants requires detailed information from postoperative radiologic assessment on the position of the array in relation to the cochlear structures. Current standard radiographic techniques provide only limited details. Materials and Methods Nucleus standard electrode arrays and perimodiolar Contour electrode arrays were implanted into the scala tympani of 11 human temporal bones. Both conventional and phase-contrast radiographs were taken of each temporal bone for comparative purposes. Results Phase-contrast imaging provides better visualization of anatomic details of the inner ear and of the structure of the intracochlear electrode array, and better definition of electrode location in relation to cochlear walls. Conclusion Phase-contrast radiography offers significant improvement over conventional radiography in images of in vitro human temporal bones. It seems to be a valuable tool in the development of intracochlear electrode arrays and cochlear implant research. However, this new radiographic technique still requires certain computational and physics challenges to be addressed before its clinical use can be established.

Actuators for the cochlear implant

The multi-channeled cochlear implant device has been proved safe and effective with simultaneous multi electrical stimulation delivered to the inner ear. It provides profoundly deaf people with the opportunity for a life transforming experience by placing them in the world of hearing. But for optimal hearing restoration a proper surgical insertion process and the close placement of the array to the heating nerves are required. To achieve this, a conducting polymer electroactuator has been developed. The electroactuator can either be inserted into the lumen of a commonly used Nucleus 24 Contour electrode or can be attached to the outside of the electrode. By varying the applied potential it is possible to steer or bend the electrode in a controllable manner. Electrosynthesis, interconnection and actuator fabrication will be discussed in detail.