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

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition Using an Evolutionary Algorithm.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from Functional Contralateral Audition with Cochlear Implant

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: audiometric tests
tone and speech audiometry
Other: Questionnaires
APHAB (Abbreviate Profile of Hearing Aid Benefit), HISQUI (Hearing Implant Sound Quality Index), Munich music questionnaire
Other: Settings of cochlear implants
pitch matching, evolutionary algorithm setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the audiometric test performances (tone and speech audiometry) before and after the cochlear implant settings based on the evolutionary algorithm with a signal to noise ratio of +5dB
Time Frame: Baseline and 60 days
Baseline and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2017

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bozorg-SAADOUN 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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