Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: CSS; Device: NFS

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02228148

CEL5332

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups

NFS

Experimental group

Description:

Cochlear Nucleus Fitting Software

Treatment:

Device: NFS

CSS

Active Comparator group

Description:

Cochlear Nucleus Custom SoundTM Suite

Treatment:

Device: CSS