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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05955469
Other study ID # MEDEL_COTONBIM_StEtienne_study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date January 1, 2026

Study information

Verified date October 2023
Source MED-EL Elektromedizinische Geräte GesmbH
Contact Vincent Péan, PhD
Phone 0603592974
Email vincent.pean@medel.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 1, 2026
Est. primary completion date September 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient (>= 18 years old) speaking French - Patient who fulfils the criteria for cochlear implantation Exclusion Criteria: - retro-cochlear pathology: auditory neuropathy, vestibular schwannoma - patient with residual hearing < 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech recognition in noise The speech recognition in noise is evaluated with the French Matrix test (Framatrix) [S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173]. at 6 weeks post-activation
Primary Speech recognition in noise The speech recognition in noise is evaluated with the French Matrix test (Framatrix) [S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173]. at 12 weeks post-activation
Secondary Speech recognition in quiet Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50. at 6 weeks post-activation
Secondary Speech recognition in quiet Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50. at 12 weeks post-activation
Secondary Auditory skills experienced by the patient Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950]. at 6 weeks post-activation
Secondary Auditory skills experienced by the patient Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950]. at 12 weeks post-activation
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