Objective and subjective evaluations of the Nurotron Venus cochlear implant system via animal experiments and clinical trials

Abstract

Conclusion: This study described objective and subjective evaluations of the Nurotron® Venus™ Cochlear Implant System and indicated that this system produced a satisfactory performance. Objective: To observe the performance of the Nurotron® Venus™ cochlear implant (CI) system via electrophysiological and psychophysical evaluations. Methods: A 26-electrode CI system was specially designed. The performance of MRI in animal and cadaveric head experiments, EABR in cats experiment, the correlation between ESRT and C level, and psychophysics evaluations in clinical trials were observed. Results: In the animal and cadaveric head experiments, magnet dislocation could not be prevented in the 1.5 T MRI without removal of the internal magnet. The EABR was clearly elicited in cat experiment. In the clinical trial, the ESRT was strongly correlated with C level (p < 0.001). The human clinical trial involving 57 post-lingually deafened native Mandarin-speaking patients was performed. Residual hearing protection in the implanted ear at each audiometric frequency was observed in 27.5–46.3% patients post-operatively. A pitch ranking test revealed that place pitches were generally ordered from apical to basal electrodes. The recognitions of the perceptions of 301 disyllabic words, environment sounds, disyllabic words, and numerals were significantly better than the pre-operative performance and reached plateaus.

Keywords:

• Cochlear implant
• electrically evoked auditory brainstem responses (EABR)
• electrically evoked stapedius reflex threshold (ESRT)
• MRI
• Nurotron
• pitch ranking
• speech perception

Acknowledgments

This study was supported by The Major State Basic Research Development Program of China (973 Program) (2011CB504500 and 2011CB504506) to H.L. and F.C.; NSFC (National Nature Science Foundation of China) 81371093 to Z.H., 81420108010 and 81271084 to F.C., 81500785 to N.G Innovation Project of Shanghai Municipal Science and Technology Commission (11411952300) to F.C.

Declaration of interest:

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.