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NCT05641155 · ClinicalTrials.gov registry record · NA
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
A NA study of Hearing Impairment, Sensorineural, sponsored by Cochlear.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 5
- Study locations
NCT05641155: Completed NA study of Hearing Impairment, Sensorineural, sponsored by Cochlear.
NCT05641155 is a NA study of Hearing Impairment, Sensorineural that has completed, run by Cochlear. The registered enrollment target is 19 participants, below the 165-participant average among 3 other Hearing Impairment, Sensorineural trials with a reported enrollment target (88% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05641155, a NA study of Hearing Impairment, Sensorineural, has completed, sponsored by Cochlear.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting
Primary Outcome
Difference between the maximum comfortable loudness level C-Level for MAP A and MAP B. This is the maximum current level that provides loud but comfortable sound level for the cochlear implant user.
Conditions Studied
Interventions
- DEVICE Focused Multipolar Stimulation (FMS) strategy
Study Locations (5)
Colorado
- Rocky Mountain Ear Center - Englewood
- Denver Research and Technology Lab - Lone Tree
Leuven
- Universitair Ziekenhuis Leuven - Leuven
Mechelen
- Cochlear Technology Centre Belgium - Mechelen
Wilrijk
- ENT Department, Sint-Augutinus Antwerp - Wilrijk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2025-12-08 |
| Phase | NA |
What the finished NCT05641155 record still lists
NCT05641155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 165-participant average among 3 other Hearing Impairment, Sensorineural trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Hearing Impairment, Sensorineural appearing as the primary indexed condition, and to 1 intervention - of which Focused Multipolar Stimulation (FMS) strategy is the first listed.
NCT05641155 lists 5 locations in 4 states (Colorado, Leuven, Mechelen).
Frequently Asked Questions
What is clinical trial NCT05641155 about?
NCT05641155 is a clinical study titled "A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.". The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that in...
What is the current status of trial NCT05641155?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2023-06-02. Estimated completion is 2025-12-08.
What conditions does trial NCT05641155 study?
This clinical trial studies the following conditions: Hearing Impairment, Sensorineural.
What interventions are being tested in trial NCT05641155?
The interventions under investigation include: Focused Multipolar Stimulation (FMS) strategy (DEVICE).
Who is sponsoring clinical trial NCT05641155?
This trial is sponsored by Cochlear, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05641155 being conducted?
This trial has 5 study locations across Colorado, Leuven, Mechelen, Wilrijk. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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