Ear DiseasesNCT06858826
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
A study testing Next Generation Sound Processor in people with Ear Diseases and Hearing Loss, Bilateral, run by Advanced Bionics.
Trial summary
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- What is being tested?
- Next Generation Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 1 Jul 2025
- 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
- Ability to provide Informed Consent
- 18 years of age or older
- Bilateral users of a HiResolution™ Bionic Ear System (HiRes 90K™, HiRes 90K™ Advantage, HiRes™ Ultra, HiRes™ Ultra 3D and CII with HiFocus electrode)
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Minimum of 6 months of CI experience for each ear
- At least moderate open-set speech recognition abilities with implant in each individual implanted ear, as defined by achieving a score of ≥ 50% words correct in the AzBio Sentence Test in quiet using a Naída CI M90 research processor
- English language proficiency, as determined by the investigator
- Willingness to use a behind-the-ear research processor for the duration of the study
Who cannot join
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
- < 50% words correct AzBio Sentence Test in quiet in either ear using the Naída CI M90 research processor
About this study
Official title: Evaluation of Advanced Bionics Next Generation CI Sound Processor Programmed With Target CI v.1.6 Fitting Software in Adult Users of the HiResolution™ Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).
Read the detailed description
The overall goal of this clinical study is to demonstrate the safety and efficacy of next generation sound processor in users of the HiResolution Bionic Ear System. Speech understanding outcomes are expected to be similar with the new sound processor as compared to the Naída CI M90 processor. Therefore, the study uses a non-inferiority design to demonstrate non-inferiority of the next generation processor, relative to the currently approved Naída CI M90 for sentence understanding in quiet and in noise. Additionally, the features on the new device will be evaluated to demonstrate spatial situational awareness using a localization tasks.
- Being tested
- Control cochlear implant sound processor, Next Generation Sound Processor
- Medical subject headings
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control cochlear implant sound processorDevice
Device: Naida M90 sound processor programmed with Target CI v1.5 software
Next Generation Sound ProcessorDevice
Device: Next generation sound processor programmed with investigation software
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Users of a HiResolution Bionic Ear System | Experimental | Control Device followed by experimental Device. Receives: Device: Control cochlear implant sound processor; Device: Next Generation Sound Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Recognition in Quiet
The primary objective is to demonstrate that speech recognition in quiet on a Next Generation CI sound processor is no worse than speech recognition in quiet on the currently approved Naída CI M90 processor for speech understanding in quiet. Scores are expressed as a percentage of words correct from 0% to 100% with higher scores indicating a better outcome. During the test the subject will be presented with a minimum of 133 words up to a maximum 159.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Mar 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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 Ear DiseasesStudies 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
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858826
- Sponsor's protocol ID
- CR0124
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2025
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Bionics Next Generation CI Sound Processor Programmed With Target CI v.1.6 Fitting Software in Adult Users of the HiResolution™ Bionic Ear System
- ClinicalTrials.gov ID
- NCT06858826
- Acronym / sponsor ID
- CR0124
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).
Detailed description
The overall goal of this clinical study is to demonstrate the safety and efficacy of next generation sound processor in users of the HiResolution Bionic Ear System. Speech understanding outcomes are expected to be similar with the new sound processor as compared to the Naída CI M90 processor. Therefore, the study uses a non-inferiority design to demonstrate non-inferiority of the next generation processor, relative to the currently approved Naída CI M90 for sentence understanding in quiet and in noise. Additionally, the features on the new device will be evaluated to demonstrate spatial situational awareness using a localization tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral Users of a HiResolution Bionic Ear System | Experimental | Device: Control cochlear implant sound processor, Device: Next Generation Sound ProcessorControl Device followed by experimental Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide Informed Consent
- 18 years of age or older
- Bilateral users of a HiResolution™ Bionic Ear System (HiRes 90K™, HiRes 90K™ Advantage, HiRes™ Ultra, HiRes™ Ultra 3D and CII with HiFocus electrode)
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Minimum of 6 months of CI experience for each ear
Key exclusion criteria (3 listed)
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
- < 50% words correct AzBio Sentence Test in quiet in either ear using the Naída CI M90 research processor
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 |
|---|---|---|
| Control cochlear implant sound processorDevice: Naida M90 sound processor programmed with Target CI v1.5 software | Device | Bilateral Users of a HiResolution Bionic Ear System |
| Next Generation Sound ProcessorDevice: Next generation sound processor programmed with investigation software | Device | Bilateral Users of a HiResolution Bionic Ear System |
Primary outcome
Speech Recognition in Quiet
Time frame: 1 Day
The primary objective is to demonstrate that speech recognition in quiet on a Next Generation CI sound processor is no worse than speech recognition in quiet on the currently approved Naída CI M90 processor for speech understanding in quiet. Scores are expressed as a percentage of words correct from 0% to 100% with higher scores indicating a better outcome. During the test the subject will be presented with a minimum of 133 words up to a maximum 159.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Sound Processor in people with Ear Diseases and Hearing Loss, Bilateral, run by Advanced Bionics.
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 3 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 Oct 2026). 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?
Speech Recognition in Quiet (time frame: 1 Day). 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 2 Oct 2026.