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 proper ties and safety of a new intracochlear perimodiolar electrode array design (Contour). Background: An electrode array positioned close to the neural elements coul d be expected to reduce stimulation thresholds and might potentially reduce channel interaction. Methods: Two sequential studies were conducted. In study I, the Contour ele ctrode array was inserted in 12 human temporal bones. After cochlear surfac e 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 tem poral bone study, study 2 investigated the Contour array, mounted on a Nucl eus CI-24 hi device and implanted in three adult patients. Results: Study 1 showed that in 10 temporal bones. the Contour array was po sitioned 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 scale vestibuli apical to the penetration. Statistical an alysis: showed an equivalent probability of insertion-induced damage of the two array designs. In study 2. image analysis indicated that the Contour e lectrodes were positioned closer to the modiolus than the standard Nucleus straight array. Lower T and C levels. but higher impedance values, were rec orded from electrodes close to the modiolus. Initial speech perception data showed that all patients gained useful open-set speech perception. two pat ients achieving scores of 100% on sentence material 3 months postoperativel y. Conclusions: The temporal bone studies showed the Contour electrode array t o be generally positioned closer to the modiolus than the standard Nucleus straight array, and to have an equivalent probability of causing insertion- induced damage.