Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
NCT ID: NCT05898659
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-10-17
2026-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Arm A: Bimodal patient's fitting with tonotopy-based fitting without synchronization (ABFnoS) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting with synchronization (ABFS) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with ABFS --\> 6 weeks use --\> tests and bimodal patient's fitting with ABFnoS --\> 6 weeks use --\> tests
OTHER
DOUBLE
Study Groups
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ABFnoS then ABFS
Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks
ABFnoS then ABFS (Cochlear implant)
Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid
ABFS then ABFnoS
Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks
ABFS then ABFnoS (Cochlear implant)
Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid
Interventions
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ABFnoS then ABFS (Cochlear implant)
Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid
ABFS then ABFnoS (Cochlear implant)
Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid
Eligibility Criteria
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Inclusion Criteria
* Patient who fulfils the criteria for cochlear implantation
* Total hearing loss for less than 5 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas Guevara, Pr
Role: PRINCIPAL_INVESTIGATOR
Nice University Hospital
Locations
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CHU Nice
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MED_EL_REG_BIMOD_Nice_study
Identifier Type: -
Identifier Source: org_study_id
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