Comparison of Nuc8 and Neuro 2 sound paths for NeuroZti cochlear implant users
Early Feasibility, Exploratory, Within-subject, Acute Study Comparing the Performance of Different Sound Paths in Adult NeuroZti CI-users
This test will see if the new Nuc8 sound path gives better or similar speech understanding and user satisfaction than the existing Neu2 path in adults who use NeuroZti cochlear implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 1 site (Vallauris) |
| Trial ID | NCT07033130 on ClinicalTrials.gov |
What this trial studies
This interventional within-subject comparison will fit adult NeuroZti cochlear implant users with both the Nuc8-based and the existing Neu2 sound paths and measure outcomes. Participants will complete speech perception tests and user-satisfaction questionnaires while using each sound path, with programs delivered via OMRP R2 and Percepolis accessory software. The trial focuses on post-lingually deaf adults implanted with the Oticon Medical Neuro ZTI device using Crystalis with autoXDP at 500pps. The aim is to determine whether switching to the Cochlear-developed Nuc8 path preserves or improves speech performance and acceptability compared with the legacy Neu2 path.
Who should consider this trial
Good fit: Adults aged 18–75 who are post-lingually deafened, implanted with an Oticon Medical Neuro ZTI cochlear implant (using Crystalis with autoXDP at 500pps), fluent in French, and willing to attend study visits and provide informed consent.
Not a fit: People who are not NeuroZti implant users, are younger than 18 or older than 75, have significant visual or cognitive impairment, have contraindicated implanted devices (e.g., pacemakers), have the excluded Antenna SD type, or cannot attend French-language visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, NeuroZti users could transition to the Nuc8 sound path and gain improved long-term support and potentially equal or better speech perception and satisfaction.
How similar studies have performed: Previous comparisons of sound processors and coding strategies in cochlear implant users have sometimes shown meaningful changes in speech perception and user preference, but a direct Nuc8 versus Neu2 comparison for NeuroZti users is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-75 years old at time of consent. 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: 1. Additional health complexities that would prevent or restrict participation in the evaluations, including significant visual impairment and/or cognitive impairment. 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).
Where this trial is running
Vallauris
- Cochlear Vallauris — Vallauris, France (Recruiting)
Study contacts
- Study coordinator: PRS Specialist
- Email: cltd-prs-admin@cochlear.com
- Phone: +612294286555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.