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

Completed

• Conditions: Cochlear Implant; Functional Contralateral Audition
• Interventions: Other: audiometric tests; Other: Questionnaires; Other: Settings of cochlear implants

• Registration Number: NCT03202797
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-03-17
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-29
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Settings of cochlear implants	-
Patients	audiometric tests	-
Patients	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
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	Baseline and 60 days

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France