Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition.

NCT ID: NCT03202797

Last Updated: 2026-02-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-17

Study Completion Date

2017-06-30

Brief Summary

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360 million people in the world suffer from debilitating hearing deficiency. The cochlear implant is indicated in certain patients with severe profound deafness. The principle of the cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear implant, activation, and follow-up regulation. There is no formal consensus to define the exact modalities for regulation during activation or follow-up, but the principles are respected according to centres that regulate cochlear implant. Bimodal audition is the fact of having a cochlear implant and a contralateral hearing aid. In patients with cochlear implants, having binaural bimodal audition improves their auditory vocal performance in silence and in noisy environments. It needs to be considered when a second cochlear implant is not indicated for the contralateral ear. It has been shown that by allocating frequencies different from the default frequencies attributed by the manufacturer, intelligibility and perception of music are modified. The investigators therefore with to study this working hypothesis and to develop a simple protocol for the reallocation of frequencies in order to optimise auditory performance in the everyday lives of patients with implants by using an evolutionary algorithm.

Detailed Description

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Conditions

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Functional Contralateral Audition Cochlear Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

audiometric tests

Intervention Type OTHER

tone and speech audiometry

Questionnaires

Intervention Type OTHER

APHAB (Abbreviate Profile of Hearing Aid Benefit), HISQUI (Hearing Implant Sound Quality Index), Munich music questionnaire

Settings of cochlear implants

Intervention Type OTHER

pitch matching, evolutionary algorithm setting

Interventions

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audiometric tests

tone and speech audiometry

Intervention Type OTHER

Questionnaires

APHAB (Abbreviate Profile of Hearing Aid Benefit), HISQUI (Hearing Implant Sound Quality Index), Munich music questionnaire

Intervention Type OTHER

Settings of cochlear implants

pitch matching, evolutionary algorithm setting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have provided consent
* Patients over 18 years old
* Profound post-lingual deafness with a cochlear implant and a functional contralateral ear (normal audition or mild to severe deafness but with a hearing aid).
* Patients fitted with one of the following cochlear implants with the most recent processor: Cochlear, Med-El, Neurelec Oticon or Advanced Bionics.
* Patients with at least 6 months experience with the cochlear implant and using both aids for at least 6 hours per day.

Exclusion Criteria

* Persons without health insurance cover
* Adults under guardianship
* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

References

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Saadoun A, Schein A, Pean V, Legrand P, Aho Glele LS, Bozorg Grayeli A. Frequency Fitting Optimization Using Evolutionary Algorithm in Cochlear Implant Users with Bimodal Binaural Hearing. Brain Sci. 2022 Feb 11;12(2):253. doi: 10.3390/brainsci12020253.

Reference Type RESULT
PMID: 35204015 (View on PubMed)

Other Identifiers

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Bozorg-SAADOUN 2016

Identifier Type: -

Identifier Source: org_study_id

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