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

Cochlear Implant Clinical Trial

— BIMODALITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202797
• Other study ID #: Bozorg-SAADOUN 2016
• Status: Completed
• Start date: March 17, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implant
• Functional Contralateral Audition

Intervention

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

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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