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

NCT03202797 | Completed

• 1 other identifier: Bozorg-SAADOUN 2016
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implant; Functional Contralateral Audition

Outcome Measures

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

  Baseline and 60 days

Study Arms (1)

Patients

Other: audiometric tests; Other: Questionnaires; Other: Settings of cochlear implants

Interventions

Settings of cochlear implants OTHER

pitch matching, evolutionary algorithm setting

Patients

audiometric tests OTHER

tone and speech audiometry

Patients

Questionnaires OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from Functional Contralateral Audition with Cochlear Implant

You may qualify if:

• 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.

You may not qualify if:

• Persons without health insurance cover
• Adults under guardianship
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 35204015 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 29, 2017
• Study Start: March 17, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)