Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
NCT ID: NCT05955469
Last Updated: 2026-01-20
Study Results
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Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-05
2027-01-01
Brief Summary
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For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
Secondary objectives:
Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.
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Detailed Description
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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.
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 the mismatch of frequencies (tonotopic shift) between the CI and the contralateral HA.
Recently MED-EL has developed an "anatomy-based fitting" (ABF) strategy based on the tonotopy that allows, from a postoperative 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.
This strategy (TFS4) could therefore allow a better integration of information in bimodal hearing and in particular improve the speech recognition in noise compared to a default strategy (FS4).
Main objective:
For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
Secondary objectives:
Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 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
Two arms A and B:
Arm A: Bimodal patient's fitting with default fitting (FS4) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with TFS4 --\> 6 weeks use --\> tests and bimodal patient's fitting with FS4 --\> 6 weeks use --\> tests
OTHER
DOUBLE
Study Groups
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FS4 then TFS4
Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks
FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting
TFS4 then FS4
Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks
TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting
Interventions
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FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting
TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting
Eligibility Criteria
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Inclusion Criteria
* Patient who fulfils the criteria for cochlear implantation
Exclusion Criteria
* patient with residual hearing \< 70 dB hearing level (HL) at 500 Hz and 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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Alexandre Karkas, Pr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Locations
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CHU Saint-Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEDEL_COTONBIM_StEtienne_study
Identifier Type: -
Identifier Source: org_study_id
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