Status:
UNKNOWN
Children's Bilateral Cochlear Implantation in Finland
Lead Sponsor:
Kuopio University Hospital
Collaborating Sponsors:
University of Eastern Finland
Hospital District of Helsinki and Uusimaa
Conditions:
Deafness
Hearing Loss
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00960102
Start Date
August 1 2009
End Date
December 31 2022
Last Update
August 17 2022
Active Locations (5)
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1
Department of Otorhinolaryngology, Helsinki University Hospital
Helsinki, Finland
2
Department of Otorhinolaryngology, Kuopio University Hospital
Kuopio, Finland, 70211
3
Department of Otorhinolaryngology, Oulu University Hospital
Oulu, Finland
4
Tampere University Hospital
Tampere, Finland