Not yet recruiting NCT07338864
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012).
- Who it may be relevant to
- Registry conditions: Hearing Loss, Hearing Implants. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation
Overview
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.
Interventions
- Device Cochlear Nucleus Nexa Cochlear implant (CI1032)
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician - Device Cochlear Nucleus Nexa Cochlear implant (CI1022)
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician - Device Cochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Primary outcome measures
- Mean within-participant change in the word recognition score in quiet [Time frame: Preimplantation to 6 months post-activation]
Secondary outcome measures (5)
- Incidence of adverse events and device deficiencies [Time frame: From enrolment to 12 months post-activation]
- Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12) [Time frame: Preimplantation to 3, 6 and 12 months post-activation]
- Mean within-participant change in word recognition score in quiet [Time frame: Preimplantation to 3 and 12 months post-activation.]
- Mean within-participant change in Living with Cochlear implants questionnaire (LivCI) [Time frame: Preimplantation to 3, 6 and 12 months post-activation]
- Mean within-subject change in speech recognition threshold in noise [Time frame: 3, 6 and 12 months post-activation]
Eligibility criteria
Inclusion criteria
- 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.
- Candidate is a fluent speaker in the language used to assess speech perception performance.
- Willing and able to comply with study follow-up schedule.
- Willing and able to provide written informed consent.
- Candidate has access to a Smartphone compatible with Nucleus Smart App.
Exclusion criteria
- 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.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Women who are pregnant.
- Current participation, or participation in an interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Düsseldorf — Düsseldorf
Identifiers
NCT: NCT07338864 · CLTD5819