Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Study Overview
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Brief Summary
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The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.

Detailed Description
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The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).

Official Title
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Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Conditions
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Deafness

Intervention / Treatment
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* Device: HiResolution Bionic Ear System (Cochlear Implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Profound bilateral hearing loss (PTA>= 90dB HL) Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling. Age at implant: 12-36 months Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS No previous cochlear implant use Normal/patent cochlea with no more than a mild partitioning defect in either ear English as the primary language spoken in the home Parental willingness to follow study protocol Exclusion Criteria: Deafness secondary to meningitis Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: HiResolution Bionic Ear System (Cochlear Implant)<br>* Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject performance on speech perception tests |  | Two years post device activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy |  | 3, 6, 12, 18, and 24 months post device activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System