Clinical Trials Directory

Trials / Completed

CompletedNCT05763342

A Study of Objective Fitting for Focused Multipolar Stimulation

An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Cochlear · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

Detailed description

This study will compare various objective and behavioural fitting methods for the programming of Focused Multipolar Stimulation. Fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. Focused Multipolar Stimulation (FMS) is an alternative to the standard of care Monopolar Stimulation (MP). FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over MP stimulation.

Conditions

Interventions

TypeNameDescription
DEVICEThe Phoenix Research SystemFocused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.

Timeline

Start date
2024-02-08
Primary completion
2025-10-20
Completion
2025-11-26
First posted
2023-03-10
Last updated
2026-02-09

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05763342. Inclusion in this directory is not an endorsement.