Both electrodes performed favorably in our human temporal bone trials, and both arrays appear promising for clinical use, especially in patients with residual hearing in whom atraumatic insertion is an important objective.
A new straight thin electrode array (universal electrode) was designed to be used together with a positioner, which will place the electrode array at the medial wall (modiolus) of the cochlea. The study objectives were to demonstrate safety and ease of insertion, tissue trauma, electrode position, and depth for universal and standard electrodes in human temporal bones; to test functional properties in cats; and to determine the surgical procedure and electrophysiological benefits in a clinical study. The cadaver study demonstrated the ease of insertion for the universal electrode and the positioner without tissue damage. An average gain of insertion depth of 180° was achieved with the positioner. Animal studies demonstrated a reduction in threshold of 6 dB for the electrical auditory brain stem response (EABR). Neither additional cochlear damage nor additional connective tissue formation was found. The intraoperative human study findings showed a marked reduction of threshold for both EABR and stapedius reflex thresholds. Impedances were increased. Plain x-rays demonstrated modiolus proximity of the electrode with the positioner. The new Clarion electrode with positioner is a relatively safe design for providing modiolus proximity. The electrophysiological benefits include reduction of threshold and power consumption.. j
The Melbourne/Cochlear multiple-electrode extracochlear implant is designed for deaf patients who are unsuited to multiple-electrode intracochlear implantation. The implant consists of a receiver-stimulator package connected via a lead wire assembly to six individual stimulating electrodes. There is a choice of two alternative surgical procedures, both of which are via a combined middle ear approach using anterior and posterior tympanotomies. Four active electrodes shaped into compressible platinum-iridium soft-balls are fed through the mastoid cavity and across the facial recess, and placed into cavities that are made over the cochlear turns that project to the medial wall of the middle ear. One hard-ball active electrode is placed into the round window niche. One hard-ball reference electrode is placed into the hypotympanum. An additional electrode wrapped around the lead wire assembly can be used as an alternative reference electrode. A specially designed insertion needle facilitates the placement and the fixation of the soft-ball electrodes.
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