Overview

This trial is active, not recruiting.

Condition hearing loss
Treatments nfs, css
Sponsor Cochlear
Collaborator numerics data GmbH
Start date November 2014
End date December 2017
Trial size 48 participants
Trial identifier NCT02228148, CEL5332

Summary

The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Cochlear Nucleus Fitting Software
nfs
Cochlear Nucleus Fitting Software
(Active Comparator)
Cochlear Nucleus Custom SoundTM Suite
css
Cochlear Nucleus Custom SoundTM Suite

Primary Outcomes

Measure
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 3 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 6 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 9 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 12 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 15 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 3 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 6 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 9 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 12 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 15 months after implantation

Secondary Outcomes

Measure
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: before first fitting post-implantation (1 day)
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 3 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 6 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 9 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 12 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 15 months after implantation
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (4 weeks after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (3 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (6 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (9 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (12 months after implantation)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid) - Post linguistically deafened adults (≥ 18 years) - Unilaterally implanted - ≤ 15 years of severe to profound deafness prior to implantation - Subjects who are capable and willing to participate in speech perception tests in local language - Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire) - Subjects willing to give their consent to the study Exclusion Criteria: - Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness) - Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method - Bilateral implantation - Hybrid-L (not supported by Nucleus Fitting Software) - Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant) - Subjects with single-sided deafness - Known cochlea malformations - Subjects who lost their hearing due to meningitis

Additional Information

Official title Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Cochlear.