The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
Study Type
OBSERVATIONAL
Enrollment
66
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
University Hospital Düsseldorf
Düsseldorf, Germany
Mean within-participant change in the word recognition score in quiet
Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome.
Time frame: Preimplantation to 6 months post-activation
Incidence of adverse events and device deficiencies
Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency
Time frame: From enrolment to 12 months post-activation
Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12)
Speech, Spatial and Qualities of Hearing Scale Global Score (SSQ-12). Scores range from 0 to 10, where high scores indicate greater ability (less hearing disability).
Time frame: Preimplantation to 3, 6 and 12 months post-activation
Mean within-participant change in word recognition score in quiet
Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome.
Time frame: Preimplantation to 3 and 12 months post-activation.
Mean within-participant change in Living with Cochlear implants questionnaire (LivCI)
Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial \& Wellbeing (range 0 to21), Stigma (range 0 to 15) and Management \& Aesthetics (range 0 to 18), where a higher domain score indicates a positive patient report.
Time frame: Preimplantation to 3, 6 and 12 months post-activation
Mean within-subject change in speech recognition threshold in noise
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Speech reception threshold for a digit triplet test where 50% of the digits are correctly identified. The score upper limit is 20 dB, with no lower limit. A lower score indicates better performance.
Time frame: 3, 6 and 12 months post-activation