The Performance of Different Sound Paths in Adult NeuroZti CI-users

NCT07033130 | Recruiting

• 1 other identifier: AI5859
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cochlear Implant; Hearing Loss, Bilateral or Unilateral

Keywords

cochlear implant; sound coding strategy; sound processor; speech perception; subjective measures

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Day 0 (Study Visit 1)

• Occurrence rate of preference using Neu2 and Nuc8 configurations for four subjective preference questions

  Day 0 (Study Visit 1)

Study Arms (1)

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.

Device: OMRP R2 + Percepolis Accessory Software; Device: Nuc8 Sound Path; Device: Neu2 Sound Path

Interventions

Nuc8 Sound Path DEVICE

Nuc8 is the sound path used in Cochlear Nucleus Sound Processors.

Sound paths in NeuroZti cochlear implant users

Neu2 Sound Path DEVICE

Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor.

Sound paths in NeuroZti cochlear implant users

OMRP R2 + Percepolis Accessory Software DEVICE

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'.

Sound paths in NeuroZti cochlear implant users

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Cochlear Vallauris

Vallauris, 06220, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PRS Specialist

  Cochlear

  STUDY DIRECTOR

Central Study Contacts

PRS Specialist

CONTACT

+612294286555; cltd-prs-admin@cochlear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)