Hearing LossNCT05270876
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
A study testing Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique in people with Hearing Loss, run by Cochlear at 5 sites in 2 countries.
Trial summary
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Oct 2020to 6 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
- At least three months of experience with the cochlear implant.
- Older than 18 years when entering the study.
- Subject is fluent speaker in the language used for assessments.
- Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- Willing and able to provide written informed consent
Who cannot join
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
AZ Sint-Jan Brugge-Oostende AV
Bruges, België, 8000
Cochlear Technology Centre Belgium
Mechelen, 2800
Sint-Augustinus Antwerpen
Wilrijk, België, 2610
Australia2 sites
HEARnet Clinical Studies - The University of Melbourne
Carlton, Victoria, 3052
Cochlear Ltd. Melbourne
East Melbourne, Victoria, 3002
About this study
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
- Conditions
- Hearing Loss
- Being tested
- Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
- 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 Implant and sound processor device fitting paradigm or diagnostic/measurement techniqueDevice
The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Other | Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method Receives: Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method
Measured: 0 to 4 weeks after fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start19 Oct 2020
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interrupted time series
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270876
- Sponsor's protocol ID
- AI5763
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2021
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
- ClinicalTrials.gov ID
- NCT05270876
- Acronym / sponsor ID
- AI5763
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interrupted time series
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Other | Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement techniqueRecipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
- At least three months of experience with the cochlear implant.
- Older than 18 years when entering the study.
- Subject is fluent speaker in the language used for assessments.
- Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
Key exclusion criteria (5 listed)
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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 Implant and sound processor device fitting paradigm or diagnostic/measurement techniqueThe investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant. | Device | Study cohort |
Primary outcome
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
Time frame: 0 to 4 weeks after fitting
The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique in people with Hearing Loss, run by Cochlear at 5 sites in 2 countries.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Australia. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet (time frame: 0 to 4 weeks after fitting). 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 10 Mar 2025.