Clinical Trial

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

Study acronym: Percepolis
Terminated
View on ClinicalTrials.gov →
Why the trial 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.
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.
Protocol Amendment History 5 changes
critical Trial terminated 2026-05-23
critical Reason stopped changed: — → 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. 2026-05-23
notable Enrollment reduced: 20 -> 4 participants 2026-05-23
notable Primary completion moved earlier: 2026-06 -> 2026-04-24 2026-05-23
minor Completion moved earlier: 2026-06 -> 2026-04-24 2026-05-23
Trial Details
NCT Number NCT07033130
Lead Sponsor Cochlear
Conditions Cochlear Implant, Hearing Loss, Bilateral or Unilateral
Enrollment 4 participants
Start Date 2026-02-24
Primary Completion 2026-04-24 (estimated)
Study Completion 2026-04-24 (estimated)
Updated on ClinicalTrials.gov 2026-05-22