The Performance of Different Sound Paths in Adult NeuroZti CI-users
NCT ID: NCT07033130
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-02-28
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sound paths in NeuroZti cochlear implant users
NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths.
OMRP R2 + Percepolis Accessory Software
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 Path
Nuc8 is the sound path used in Cochlear Nucleus Sound Processors.
Neu2 Sound Path
Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor.
Interventions
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OMRP R2 + Percepolis Accessory Software
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 Path
Nuc8 is the sound path used in Cochlear Nucleus Sound Processors.
Neu2 Sound Path
Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor.
Eligibility Criteria
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Inclusion Criteria
2. Post-lingually deafened.
3. 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.
4. Fluent in French as determined by the investigator.
5. Willing to participate and comply with requirements of the protocol
6. Willing and able to provide written informed consent.
Exclusion Criteria
2. Subjects who have life sustaining devices (such as pacemakers).
3. NeuroZti Subjects with Antenna SD Type.
4. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
5. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
6. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
7. Pregnant or breastfeeding women.
8. 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).
18 Years
75 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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PRS Specialist
Role: STUDY_DIRECTOR
Cochlear
Locations
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Cochlear Vallauris
Vallauris, , France
Countries
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Central Contacts
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Other Identifiers
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AI5859
Identifier Type: -
Identifier Source: org_study_id
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