Optimization of Hearing Performance in the Subject Implanted

Study Overview
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Brief Summary
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In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.

Official Title
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Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness

Conditions
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Hearing Loss

Intervention / Treatment
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* Procedure: Program A
* Procedure: Program B
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni) Person with almost normal or moderate contralateral hearing ( under 60dB) Cochlear implanted person whose activation has not yet been performed Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant Affiliated to social security Exclusion Criteria: - Subjects under juridical protections or tutelage measure Subjects with associated neurological or neurodegenerative conditions Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: two within-subject crossover experiments (short-term and long-term) where each subject will follow two phases of the protocol (training A and training B).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training A<br>Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates | Procedure: Program A<br>* Presentation of the sentence to the implant alone<br>|
| Experimental: Training B<br>Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates | Procedure: Program B<br>* Presentation of the sentence to the implanted ear, associated for the non-implanted ear<br>|
| Active Comparator: Control<br>Training in bilaterally postlingually-deafened adult cochlear implanted candidates | Procedure: Control<br>* Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the percentage of correct speech recognition after training between the two training programs |  | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deafness, cochlear implant