Clarion 1.2 standard electrode array with partial space-filling positioner: radiological and histological evaluation in human temporal bones.

The purpose of this study was to evaluate whether use of a positioner for situating the Clarion 1.29 standard electrode array in close proximity to the modiolus, causes damage to fine intra-cochlear structures, and to provide a comparison with results obtained for insertions of the array performed without a positioner. The study was performed in seven freshly frozen human temporal bones. Electrode location and intra-cochlear trauma was analysed using cross-sectional imaging and histological analysis. Insertion of the Clarion array did not reveal major trauma. The devices inserted with the positioner showed a consistently closer location of the electron array towards the modiolus, however, insertion resulted in significant displacement of both the electrode array and the positioner resulting in severe destruction of the basilar membrane and osseous spiral lamina along the length of the basal and middle turns. The devices inserted with the positioner resulted in major trauma to the basilar membrane and osseous spiral lamina. Therefore, systematic safety studies in larger samples of human temporal bones should be performed and the results carefully evaluated before implantation can be recommended unreservedly.

Nondestructive three-dimensional analysis of electrode to modiolus proximity.

PURPOSE: To propose a nondestructive method for three-dimensional analysis of inner ear morphology after cochlear implantation for isolated petrous bones. MATERIALS AND METHODS: After implantation of cochlear implant electrode arrays, fresh temporal bones were investigated on a new C-arm-based radiographic device permitting the generation of cross-sectional images and of three-dimensional models from multiple two-dimensional radiographic images taken under different projections (cone-beam computed tomography). Cross-sectional images and multiplanar reformations with a slice thickness of 0.15 mm were acquired. The relationship of the electrode to the modiolus was analyzed (distance between electrode and the modiolus; position of the electrode inside the tympanic or vestibular scale). Histologic preparation was used as a gold standard. RESULTS: In all cases, cone-beam computed tomography gave similar information concerning the position of the electrode compared with histologic analysis (tympanic scale versus vestibular scale, proximity versus distance to the modiolus). Perforation of the electrode from the tympanic to the vestibular scale could be assessed three-dimensionally in the cross-sectional images. In contrast to histology, cross-sectional imaging based on radiography is performed in less than 10 minutes and needs no preparation of the object. Because it is nondestructive, it can be repeated and used as a control after position-correcting maneuvers. CONCLUSION: Cross-sectional imaging based on radiography is a valuable tool for the analysis of the electrode-modiolus relationship after cochlear implantation in isolated temporal bones, which may confirm histologic analysis.