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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMED-EL Elektromedizinische Geräte GesmbH

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

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

    Device

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activatedActive comparator 1 intervention
Group B: CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activatedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 1 month post-activation
2

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.

Time frame
at 2 months post-activation

Secondary outcomes

1

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.

Time frame
at 1 month post-activation
2

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.

Time frame
at 2 months post-activation
3

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%).

Time frame
at 1 month post-activation
4

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%).

Time frame
at 2 months post-activation

Other outcomes

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