Cochlear ImplantPercepolisNCT07033130
The Performance of Different Sound Paths in Adult NeuroZti CI-users
A study testing OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path and Neu2 Sound Path in people with Cochlear Implant and Hearing Loss, Bilateral or Unilateral, run by Cochlear at 1 site in France.
Trial summary
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cochlear Implant, Hearing Loss, Bilateral or Unilateral
- What is being tested?
- OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path and Neu2 Sound Path
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2026to 24 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old at time of consent.
- Post-lingually deafened.
- Bilaterally or unilaterally implanted with Oticon Medical Neuro ZTI cochlear implant, using Crystalis with autoXDP (GMCI 'CAP') as the main program, at 500pps stimulation rate. For bilateral CI users, only first-implanted side will be tested.
- Fluent in French as determined by the investigator.
- Willing to participate and comply with requirements of the protocol
- Willing and able to provide written informed consent.
Who cannot join
- Additional health complexities that would prevent or restrict participation in the evaluations, including significant visual impairment and/or cognitive impairment.
- Subjects who have life sustaining devices (such as pacemakers).
- NeuroZti Subjects with Antenna SD Type.
- 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 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.
- Pregnant or breastfeeding women.
- Current participation, or participation in another 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.
About this study
Official title: Early Feasibility, Exploratory, Within-subject, Acute Study Comparing the Performance of Different Sound Paths in Adult NeuroZti CI-users
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
Following Cochlear's acquisition of Neurelec, there is a need to support existing NeuroZti implant users who currently rely on the Neuro 2 sound processor. The Nuc8-based sound processor, currently in development, is designed to be compatible with the Neuro system while integrating with Cochlear's ecosystem of tools and applications developed over the past decade.
Read more
To ensure long-term support and maintainability, transitioning to the Nuc8 sound path is preferred. However, changes in sound paths may impact sound quality, speech perception, and user acceptance.
The main question this study aims to answer is: how does speech performance and user satisfaction compare between the Nuc8 and Neu2 sound paths?
Participants will:
- Undergo speech perception testing in quiet environments
- Provide ratings on comfort and overall satisfaction
The study involves a single visit lasting approximately 3 hours.
- Being tested
- OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path, Neu2 Sound Path
- Keywords
- cochlear implant, sound coding strategy, sound processor, speech perception, subjective measures
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMRP R2 + Percepolis Accessory SoftwareDevice
The Oticon Medical Research Platform Release 2 (OMRP R2) + Percepolis Accessory Software is an investigational or research tool that includes hardware, firmware and software elements, which can connect to an Oticon Medical Cochlear Implant (CI). It is intended to be used exclusively for research with Oticon Medical CI users participating in research experiments or clinical studies. The hardware components are referred to as 'OMRP R2' and the software components are called 'Percepolis Accessory Software'.
Nuc8 Sound PathDevice
Nuc8 is the sound path used in Cochlear Nucleus Sound Processors.
Neu2 Sound PathDevice
Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor.
| Study group | Role | What they receive |
|---|---|---|
| Sound paths in NeuroZti cochlear implant users | Experimental | NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths. Receives: Device: OMRP R2 + Percepolis Accessory Software; Device: Nuc8 Sound Path; Device: Neu2 Sound Path |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths
This involves testing open-set speech perception performance at simulated input of 65 dB SPL, which represents speech spoken at a normal conversational level. The word test will be performed in the sound field at 0° azimuth. Upon hearing the word, participants are instructed to repeat back the word, and the experimenter will score the recognition correct as either correct (i.e., when the subject repeat the exact word) or incorrect (i.e., when the subject does not repeat the exact word).
Measured: Day 0 (Study Visit 1)
Secondary outcomes (2)
Percentage disyllabic word recognition scores in quiet at stimulated input level of 55 dB SPL and at 40 dB SPL for both Nuc8 and Neu2 sound paths
This involves testing softer levels of 55 dB SPL and 40 dB SPL to investigate differences in speech coding and dynamic range management system over a range of levels.
Measured: Day 0 (Study Visit 1)
Occurrence rate of preference using Neu2 and Nuc8 configurations for four subjective preference questions
This outcome measure involves a comparison of subjective comfort and satisfaction with Neu2 versus Nuc8 sound paths. Participants will judge the quality and comfort of various sounds that are presented, answering four questions:
Q1: Which one sounds louder? Q2: Which one sounds clearer? Q3: Which one sounds more pleasant? Q4: Which one do you prefer listening to everyday in your behind the ear sound processor?
Measured: Day 0 (Study Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start24 Feb 2026
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Why it stopped: Preliminary feasibility outcomes from 4 enrolled participants met expectations. Following a serious adverse event that is unrelated to the investigational device/procedures, a risk-benefit assessment determined additional enrolment was not justified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PRS Specialist, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033130
- Sponsor's protocol ID
- AI5859
- Acronym
- Percepolis
- Status last verified
- May 2026
- First submitted
- 13 Jun 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility, Exploratory, Within-subject, Acute Study Comparing the Performance of Different Sound Paths in Adult NeuroZti CI-users
- ClinicalTrials.gov ID
- NCT07033130
- Acronym / sponsor ID
- Percepolis / AI5859
- Keywords
- cochlear implant, sound coding strategy, sound processor, speech perception, subjective measures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary feasibility outcomes from 4 enrolled participants met expectations. Following a serious adverse event that is unrelated to the investigational device/procedures, a risk-benefit assessment determined additional enrolment was not justified.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 24 Jun 2025 (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 goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
Following Cochlear's acquisition of Neurelec, there is a need to support existing NeuroZti implant users who currently rely on the Neuro 2 sound processor. The Nuc8-based sound processor, currently in development, is designed to be compatible with the Neuro system while integrating with Cochlear's ecosystem of tools and applications developed over the past decade.
To ensure long-term support and maintainability, transitioning to the Nuc8 sound path is preferred. However, changes in sound paths may impact sound quality, speech perception, and user acceptance.
The main question this study aims to answer is: how does speech performance and user satisfaction compare between the Nuc8 and Neu2 sound paths?
Participants will:
- Undergo speech perception testing in quiet environments
- Provide ratings on comfort and overall satisfaction
The study involves a single visit lasting approximately 3 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sound paths in NeuroZti cochlear implant users | Experimental | Device: OMRP R2 + Percepolis Accessory Software, Device: Nuc8 Sound Path, Device: Neu2 Sound PathNeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years old at time of consent.
- Post-lingually deafened.
- Bilaterally or unilaterally implanted with Oticon Medical Neuro ZTI cochlear implant, using Crystalis with autoXDP (GMCI 'CAP') as the main program, at 500pps stimulation rate. For bilateral CI users, only first-implanted side will be tested.
- Fluent in French as determined by the investigator.
- Willing to participate and comply with requirements of the protocol
Key exclusion criteria (8 listed)
- Additional health complexities that would prevent or restrict participation in the evaluations, including significant visual impairment and/or cognitive impairment.
- Subjects who have life sustaining devices (such as pacemakers).
- NeuroZti Subjects with Antenna SD Type.
- 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 a 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 |
|---|---|---|
| OMRP R2 + Percepolis Accessory SoftwareThe Oticon Medical Research Platform Release 2 (OMRP R2) + Percepolis Accessory Software is an investigational or research tool that includes hardware, firmware and software elements, which can connect to an Oticon Medical Cochlear Implant (CI). It is intended to be used exclusively for research with Oticon Medical CI users participating in research experiments or clinical studies. The hardware components are referred to as 'OMRP R2' and the software components are called 'Percepolis Accessory Software'. | Device | Sound paths in NeuroZti cochlear implant users |
| Nuc8 Sound PathNuc8 is the sound path used in Cochlear Nucleus Sound Processors. | Device | Sound paths in NeuroZti cochlear implant users |
| Neu2 Sound PathNeu2 is the sound path that is currently used in the Neuro 2 Sound Processor. | Device | Sound paths in NeuroZti cochlear implant users |
Primary outcome
Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths
Time frame: Day 0 (Study Visit 1)
This involves testing open-set speech perception performance at simulated input of 65 dB SPL, which represents speech spoken at a normal conversational level. The word test will be performed in the sound field at 0° azimuth. Upon hearing the word, participants are instructed to repeat back the word, and the experimenter will score the recognition correct as either correct (i.e., when the subject repeat the exact word) or incorrect (i.e., when the subject does not repeat the exact word).
2 secondary outcomes
Percentage disyllabic word recognition scores in quiet at stimulated input level of 55 dB SPL and at 40 dB SPL for both Nuc8 and Neu2 sound paths
Time frame: Day 0 (Study Visit 1)
Occurrence rate of preference using Neu2 and Nuc8 configurations for four subjective preference questions
Time frame: Day 0 (Study Visit 1)
Results and safety
The study was stopped early (reason given: Preliminary feasibility outcomes from 4 enrolled participants met expectations. Following a serious adverse event that is unrelated to the investigational device/procedures, a risk-benefit assessment determined additional enrolment was not justified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Related trials for Cochlear Implant
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
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.
PRS Specialist study director
Cochlear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path and Neu2 Sound Path in people with Cochlear Implant and Hearing Loss, Bilateral or Unilateral, run by Cochlear at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 22 May 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 France. 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?
The study was stopped early (reason given: Preliminary feasibility outcomes from 4 enrolled participants met expectations. Following a serious adverse event that is unrelated to the investigational device/procedures, a risk-benefit assessment determined additional enrolment was not justified.). Results are not available in the source record.
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?
Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths (time frame: Day 0 (Study Visit 1)). 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 May 2026.