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OpenTrials
Completed

NCT Number: NCT03202797

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

audiometric tests

Other

tone and speech audiometry

questionnaires

Other

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

Settings of cochlear implants

Other

pitch matching, evolutionary algorithm setting

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: BIMODALITE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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