Objective: To evaluate the new Clarion CII cochlear implant with the perimodiolar HiFocus electrode array, including both speech perception outcomes and the device's capabilities of measuring the electrically evoked compound action potential (eCAP) of the auditory nerve (Neural Response Imaging, NRI).
Design: The speech perception scores on CVC words without lip reading were monitored prospectively for the 10 postlingually deaf patients implanted with the Clarion CII device in the period July 2000 until May 2001 in the Leiden University Medical Center. Preoperative and postoperative NRI recordings were made, applying various combinations of monopolar stimulating and recording electrodes with the alternating polarity paradigm available in the test bench software.
Results: Nine patients preferred the CIS, one the PPS strategy, none the SAS strategy. With their favorite strategy they acquired significant open set speech understanding within a few weeks, resulting in an average CVC phoneme score of 84% (word score 66%) at the end of the study (follow-up 3 to 11 mo). In speech-shaped noise, the average phoneme recognition threshold (PRT) was reached at a signal to noise ratio just below 0 dB. The NRI recordings had clear N1 and P1 peaks if there was at least one contact between the stimulating and recording electrodes, necessitating just 15 sweeps for a reliable recording. We observed considerable inter-patient and inter-electrode variability, but for a given situation NRI input/output curves were stable over time. More apical contacts generally elicited larger eCAPs. Response amplitudes tended to peak at recording sites around apical and basal stimulating electrodes, suggesting a limited spread of excitation. Preliminary recordings with the forward masking paradigm were consistent with the ones with the alternating polarity scheme.
Conclusions: The Clarion CII is a promising cochlear implant with which our first 10 patients have obtained excellent speech perception results. The NRI system yields high quality signals with a limited number of sweeps at a high sampling rate.