Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Condition(s) studied
Investigational drug(s) / intervention(s)
FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated: Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated
Study summary
Main objective:
Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater.
Secondary objectives:
Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
Eligibility
Primary outcome measure(s)
- Qualitative measure of music with direct audio link — at 1 month post-activation
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI. - Qualitative measure of music with direct audio link — at 2 months post-activation
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| GH Pitié-Salpêtrière, APHP 6 | Paris | France | Recruiting |
More MED-EL Elektromedizinische Geräte GmbH trials in France
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04591093 on ClinicalTrials.gov ↗ ← All trials in France