A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCochlear
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older (at time of consent).
Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
Disqualifiers
Prior cochlear implantation in the ear to be implanted.
Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Trial population
Post lingually deafened adult adults who are a candidate for cochlear implantation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cochlear Nucleus Nexa Cochlear implant (CI1032)
DeviceParticipants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1022)
DeviceParticipants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1012)
DeviceParticipants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Cochlear implant (CI1032)1 intervention
Group B: Cochlear implant (CI1022)1 intervention
Group C: Cochlear implant (CI1012)1 intervention
Trial outcomes
Primary outcomes
1
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-activationSecondary outcomes
1
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-activation2
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-activation3
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.4
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 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: