Hearing Loss
Conditions
Keywords
Post linguistically deafness, severe to profound deafness
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.
Interventions
Sponsors
numerics data GmbH
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds | 3 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 | 3 months after implantation | Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB. |
Secondary
| Measure | Time frame |
|---|---|
| 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) | before first fitting post-implantation (1 day) |
| 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 (4 weeks after implantation) |
Countries
Germany, Switzerland
Outcome results
None listed