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, multiprogram mable cochlear implant system. Over a period of 5 years, the Clarion h as been collaboratively developed by UCSF, the Research Triangle Insti tute (RTI) of North Carolina, and the device manufacturer and sponsor, MiniMed Technologies of Sylmar, California. For UCSF, it represents t he culmination of 21 years or cochlear implant research. The Clarion i ncorporates the 16-contact electrode array developed at UCSF. This ele ctrode is designed with a gentle curve and an elastic memory that allo w it to hug the modiolar wall of the scala tympani. In addition, the e lectrode 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 developm ent of an electrode insertion tool to assist the surgeon in safe place ment. In each of the six UCSF cases, the insertion tool was used and e lectrode 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 som e degree of open-set, auditory-only speech recognition. Surgical consi derations and preliminary audiologic data demonstrate that the design rationale and objectives of the Clarion have been met.