About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Trial design
Crossover
Treatments tested in this trial
FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
DeviceCochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated
Treatment groups
Trial outcomes
Primary outcomes
Qualitative measure of music with direct audio link
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
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.
Secondary outcomes
Qualitative measure of music
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 in free field without any contralateral aid.
Qualitative measure of music
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 in free field without any contralateral aid.
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Sponsors and contacts
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