A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
ORBIT-MU
A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation
1 other identifier
observational
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2026
CompletedFirst Posted
Study publicly available on registry
January 14, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
April 2, 2026
March 1, 2026
2 years
January 4, 2026
March 29, 2026
Conditions
Outcome Measures
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.
Preimplantation to 6 months post-activation
Secondary Outcomes (5)
Incidence of adverse events and device deficiencies
From enrolment to 12 months post-activation
Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12)
Preimplantation to 3, 6 and 12 months post-activation
Mean within-participant change in word recognition score in quiet
Preimplantation to 3 and 12 months post-activation.
Mean within-participant change in Living with Cochlear implants questionnaire (LivCI)
Preimplantation to 3, 6 and 12 months post-activation
Mean within-subject change in speech recognition threshold in noise
3, 6 and 12 months post-activation
Study Arms (3)
Cochlear implant (CI1032)
Participants implanted with a CI1032
Cochlear implant (CI1022)
Participants implanted with a CI1022
Cochlear implant (CI1012)
Participants implanted with a CI1012
Interventions
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
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Eligibility Criteria
Post lingually deafened adult adults who are a candidate for cochlear implantation.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (1)
University Hospital Düsseldorf
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2026
First Posted
January 14, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share