A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults (ORBIT-MU)

March 29, 2026 updated by: Cochlear

A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • University Hospital Düsseldorf
        • Principal Investigator:
          • Thomas Klenzner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Post lingually deafened adult adults who are a candidate for cochlear implantation.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear implant (CI1032)
Participants implanted with a CI1032
Device: 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
Device: 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
Device: Cochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean within-participant change in the word recognition score in quiet
Time Frame: Preimplantation to 6 months post-activation

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and device deficiencies
Time Frame: From enrolment to 12 months post-activation
Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency
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
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).
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.
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 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
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.
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
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.
3, 6 and 12 months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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