Clarion cochlear implant: phase I investigational results.
Under phase I of an FDA-approved Investigational Device Exemption (IDE), six patients at the University of California, San Francisco (UCSF) have been implanted with the Clarion, a new multichannel, multiprogrammable cochlear implant system. Over a period of 5 years, the Clarion has been collaboratively developed by UCSF, the Research Triangle Institute (RTI) of North Carolina, and the device manufacturer and sponsor, MiniMed Technologies of Sylmar, California. For UCSF, it represents the culmination of 21 years of cochlear implant research. The Clarion incorporates the 16-contact electrode array developed at UCSF. This electrode is designed with a gentle curve and an elastic memory that allow it to hug the modiolar wall of the scala tympani. In addition, the electrode has mechanical features that prevent it from rotating upward and injuring the basilar membrane. One of the innovations necessary to allow broad clinical application of this device has been the development of an electrode insertion tool to assist the surgeon in safe placement. In each of the six UCSF cases, the insertion tool was used and electrode placement was achieved with ease. With the availability of a variety of speech processing strategies, the Clarion has also provided the opportunity for all of the patients tested to date to achieve some degree of open-set, auditory-only speech recognition. Surgical considerations and preliminary audiologic data demonstrate that the design rationale and objectives of the Clarion have been met.
Department of Otolaryngology, University of California, San Francisco School of Medicine 94143-0340.
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Schindler
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Kessler
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Haggerty
D000368:Aged; D000369:Aged, 80 and over; D003051:Cochlea / Q000502:physiology / Q000601:surgery; D003054:Cochlear Implants; D004582:Electronics, Medical / Q000295:instrumentation*; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012984:Software; D013525:Surgical Instruments; D014481:United States; D014486:United States Food and Drug Administration; D000159:Vestibulocochlear Nerve / Q000502:physiology