Clinical trial NCT02228148: Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
Official title: Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Post linguistically deafness, severe to profound deafness
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: numerics data GmbH
First posted: 2014-08-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

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
timeFrame: 3 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
timeFrame: 6 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
timeFrame: 9 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
timeFrame: 12 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
timeFrame: 15 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
timeFrame: 3 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
timeFrame: 6 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
timeFrame: 9 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
timeFrame: 12 months after implantation
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
timeFrame: 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)
timeFrame: before first fitting post-implantation (1 day)
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)
timeFrame: 3 months after implantation
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)
timeFrame: 6 months after implantation
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)
timeFrame: 9 months after implantation
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)
timeFrame: 12 months after implantation
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)
timeFrame: 15 months after implantation
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
timeFrame: after each fitting (4 weeks after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
timeFrame: after each fitting (3 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
timeFrame: after each fitting (6 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
timeFrame: after each fitting (9 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
timeFrame: after each fitting (12 months after implantation)
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Deutsches HörZentrum Hannover der HNO-Klinik der MHH
state: Niedersachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
state: Schleswig-Holstein
city: Zurich
country: Switzerland
facility: Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
state: Kanton Zurich
Study officials:
affiliation: Cochlear
name: Bart Volckaerts, PhD
role: STUDY_DIRECTOR
References: