NCT07033130

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

Early Feasibility, Exploratory, Within-subject, Acute Study Comparing the Performance of Different Sound Paths in Adult NeuroZti CI-users

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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'.
DEVICE	Nuc8 Sound Path	Nuc8 is the sound path used in Cochlear Nucleus Sound Processors.
DEVICE	Neu2 Sound Path	Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-24
• Last updated: 2026-02-25

Locations

1 site across 1 country: France