Ireland
--:--IST
Recruiting Not applicable

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT04591093 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-07-10
Last updated
2025-11-19

Condition(s) studied

Sensorineural Hearing Loss, Bilateral

Investigational drug(s) / intervention(s)

FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient (≥ 18 years old) speaking French * Patient who fulfils the criteria for cochlear implantation * Patient with a postoperative insertion angle of the apical electrode \> 450° * Patient with 12 active electrodes on the day of activation. Exclusion Criteria: * Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

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)

FacilityCityRegionStatus
GH Pitié-Salpêtrière, APHP 6 Paris France Recruiting
Official registry record

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