Hearing LossORBIT-MUNCT07338864
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
An observational study of Hearing Loss and Hearing Implants, run by Cochlear at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Implants
- What is being tested?
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022) and Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post lingually deafened adult adults who are a candidate for cochlear implantation.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Hearing Loss, Hearing Implants
- Being tested
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Nucleus Nexa Cochlear implant (CI1032)Device
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1022)Device
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
Cochlear Nucleus Nexa Cochlear implant (CI1012)Device
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant (CI1032) | Participants implanted with a CI1032 Receives: Device: Cochlear Nucleus Nexa Cochlear implant (CI1032) | |
| Cochlear implant (CI1022) | Participants implanted with a CI1022 Receives: Device: Cochlear Nucleus Nexa Cochlear implant (CI1022) | |
| Cochlear implant (CI1012) | Participants implanted with a CI1012 Receives: Device: Cochlear Nucleus Nexa Cochlear implant (CI1012) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preimplantation to 6 months post-activation
Secondary outcomes (5)
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
Measured: From enrolment to 12 months post-activation
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).
Measured: Preimplantation to 3, 6 and 12 months post-activation
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.
Measured: Preimplantation to 3 and 12 months post-activation.
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.
Measured: Preimplantation to 3, 6 and 12 months post-activation
Mean within-subject change in speech recognition threshold in noise
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.
Measured: 3, 6 and 12 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338864
- Sponsor's protocol ID
- CLTD5819
- Acronym
- ORBIT-MU
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07338864
- Acronym / sponsor ID
- ORBIT-MU / CLTD5819
- Conditions
- Hearing Loss, Hearing Implants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant (CI1032) | – | Device: Cochlear Nucleus Nexa Cochlear implant (CI1032)Participants implanted with a CI1032 |
| Cochlear implant (CI1022) | – | Device: Cochlear Nucleus Nexa Cochlear implant (CI1022)Participants implanted with a CI1022 |
| Cochlear implant (CI1012) | – | Device: Cochlear Nucleus Nexa Cochlear implant (CI1012)Participants implanted with a CI1012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post lingually deafened adult adults who are a candidate for cochlear implantation.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Nucleus Nexa Cochlear implant (CI1032)Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician | Device | Cochlear implant (CI1032) |
| Cochlear Nucleus Nexa Cochlear implant (CI1022)Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician | Device | Cochlear implant (CI1022) |
| Cochlear Nucleus Nexa Cochlear implant (CI1012)Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician | Device | Cochlear implant (CI1012) |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Hearing Implants, run by Cochlear at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cltd-prs-admin@cochlear.com PRS Specialist (61 2 9428 6555, cltd-prs-admin@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean within-participant change in the word recognition score in quiet (time frame: Preimplantation to 6 months post-activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.