A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
NCT ID: NCT07338864
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
66 participants
OBSERVATIONAL
2026-04-30
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cochlear implant (CI1032)
Participants implanted with a CI1032
Cochlear Nucleus Nexa Cochlear implant (CI1032)
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Cochlear implant (CI1022)
Participants implanted with a CI1022
Cochlear Nucleus Nexa Cochlear implant (CI1022)
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Cochlear implant (CI1012)
Participants implanted with a CI1012
Cochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Interventions
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Cochlear Nucleus Nexa Cochlear implant (CI1032)
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1022)
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Countries
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Central Contacts
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Other Identifiers
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CLTD5819
Identifier Type: -
Identifier Source: org_study_id
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