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32-CHANNEL COCHLEAR IMPLANT SYSTEM FOR CLINICAL USE
COCHLEAR IMPLANT DIVISION, TODOC COMPANY LIMITED1, OTORHINOLARYNGOLOGY, SEOUL NATIONAL UNIVERSITY HOSPITAL2
KYOU-SIK MIN, KYOU-SIK MIN1, HOSEUNG LEE1, JEONGWOO LIM1, WOOJIN AHN1, SOOWON SHIN1, YOONHEE HA1, GWANGJIN CHOI1, DOOHEE KIM1, JUNEWOO HYUN1, SANGWOO KIM1, EUNSOO KIM1, JISOO KWON1, HYOMIN PARK1, JEONSOO KANG1, SEUNGHOON LEE1, SEUNGHA OH2
¸ñÀû: One of the main reasons making cochlear implant cost high is manual fabrication of electrode array. For decades, there have been efforts to make affordable CI systems with safety and efficacy to reduce the cost of conventional cochlear implant. However, approaches using manufacturable and automated process accompanies problems in biocompatibility qualification and manufacturing yield. In this study, we introduce manufacturable cochlear electrode array fabricated by semi-automated micro-machining process and 32-channel cochlear implant system for clinical use. ¹æ¹ý:Electrode array comprising of electrodes and lead wires is micro- machined using picosecond laser at once on platinum-iridium alloy film which has been used as raw material for commercial cochlear electrode array for nearly 40 years. For electrode array is manufactured in layer-by-layer deposition scheme, the planar structure of the lead wire array are formed in 3-dimensional wavy structure for flexibility of the lead. To assess the clinical feasibility of the electrode array, its mechanical and electrochemical characteristics are measured by universal testing machine and potentiostat, respectively. The team also has developed 32-channel stimulator and receiver ASIC with novel I-DAC technology which adjusts amplitude resolution according to gap between C-T level of each channel. For clinical application, implant circuits and components are hermetically packaged in Ti6Al4V alloy cavity and platinum-ceramic feedthrough using brazing and laser- welding. Authors use commercial hearing-aid audio processor to minimize additional development cost. °á°ú:Patterned electrode contacts and wires array is encapsulated by silicone elastomer forming carrier. The dimensions of the electrode array are 20 to 24 mm in length and 0.45 to 0.8 mm in diameter from the tip to the base.The Impedance spectroscopy results shows that the impedance of the electrodes are around 3 kOhm at 1 kHz. Charge storage capacity is around 5 mC/cm2. We compared the insertion force of our electrode array to conventional wire-based electrode array manufactured by nurobiosys. At the 8 mm displacement from round window, the insertion force is 17.4mN which is slightly less than that of 16-channel wire-based conventional electrode array. The device underwent the ISO 14708-compliant tests from GLP certified test laboratory. °á·Ð:Automated laser-micromachined neural interface fabrication method based on conventional biocompatible material is developed. We manufactured 32-channel intracochlear electrode array using suggested method. The electrode and lead array is certified by ISO-compliant tests. And 32-channel cochlear implant system including custom IC and sound processor is developed and is waiting for KFDA approval.


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