Children's Bilateral Cochlear Implantation in Finland

Study Overview
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Brief Summary
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The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.

Official Title
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Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study

Conditions
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Hearing Loss, Deafness

Intervention / Treatment
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* Device: cochlear implant
* Device: hearing aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital severe or profound bilateral hearing impairment No functional benefit from conventional hearing aids (minimum 3 months trial) Radiologically (CT,MRI) patent inner ears and normal central auditory pathways Family is motivated for rehabilitation programme and gives a written consent Finnish or Swedish as the primary language in the home Exclusion Criteria: A child has an additional anomaly or disability that may affect to his/her functional or neurological development Inner ear anomaly Mother's pregnancy duration less than 32 weeks

Ages Eligible for Study
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Maximum Age: 24 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilateral cochlear implant<br> | Device: cochlear implant<br>* Multichannel Nucleus cochlear implant<br>|
| Active Comparator: cochlear implant and hearing aid<br> | Device: cochlear implant<br>* Multichannel Nucleus cochlear implant<br>Device: hearing aid<br>* Phonak hearing aid<br>|
| Active Comparator: bilateral hearing aid<br> | Device: hearing aid<br>* Phonak hearing aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids |  | Various time points up to 5 years hearing age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare post-operative speech perception ability, language acquisition, and speech production |  | Various time points up to 5 years hearing age | 
| To compare speech recognition performance |  | Various time points up to 5 years hearing age | 
| Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment |  | Various time points up to 5 years hearing age | 
| To evaluate operative and post-operative complications, side-effects and device failures |  | Various time points up to 5 years hearing age | 
| To evaluate the differences in balance function |  | at 3 and 5 year age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implantation, hearing aid