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MED_EL_REG_BIMOD_NICE_STUDY

Comparison in new cochlear implanted subjects of a tonotopy-based bimodal fitting with or without synchronization
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05898659
cochlear implant
bimodal fitting
tonotopy-based fitting
Source :Importé depuis le centre
Recrutement ouvert
Dernière modification : 2026/01/13
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Limites d'âge
minimum : 18 ans
Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Adult patient (\>= 18 years old) speaking French
* Patient who fulfils the criteria for cochlear implantation
* Total hearing loss for less than 5 years

Exclusion Criteria:

* retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
* patient with residual hearing \< 70 dB hearing level (HL) at 250 Hz and 500 Hz and \< 80 dB HL at 1000 Hz on the contralateral ear

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
ABFnoS then ABFS Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks Donnée non disponible
  • Inconnu
  • ABFS then ABFnoS Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks Donnée non disponible
  • Inconnu
  • ABFnoS then ABFS
    État du recrutement
    unknown
    ABFS then ABFnoS
    État du recrutement
    unknown
    Données à jour depuis : 13 janvier 2026

    Description de l'étude

    Résumé de l'étude

    Main objective:

    For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

    Secondary objectives:

    Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

    Source : Importé depuis le centre

    Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain.

    A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

    MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.

    Bimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side.

    This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.

    This variability could be due to different processing times between CI and contralateral HA.

    Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA).

    This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS).

    Main objective:

    For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

    Secondary objectives:

    Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

    Plan of the study:

    It is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 13 janvier 2026
    Données à jour depuis : 15 jan.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05898659