Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
- Conditions
- Hearing Loss
- Interventions
- Device: NFSDevice: CSS
- Registration Number
- NCT02228148
- Lead Sponsor
- Cochlear
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NFS NFS Cochlear Nucleus Fitting Software CSS CSS Cochlear Nucleus Custom SoundTM Suite
- Primary Outcome Measures
Name Time Method Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds 15 months after implantation Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests 15 months after implantation Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
- Secondary Outcome Measures
Name Time Method 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) 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 after each fitting (12 months after implantation)
Trial Locations
- Locations (3)
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
🇨🇭Zurich, Kanton Zurich, Switzerland
Deutsches HörZentrum Hannover der HNO-Klinik der MHH
🇩🇪Hannover, Niedersachsen, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
🇩🇪Kiel, Schleswig-Holstein, Germany