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

Kuopio University Hospital5 sites in 1 country40 target enrollmentAugust 2009

ConditionsDeafness Hearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Deafness
Sponsor: Kuopio University Hospital
Enrollment: 40
Locations: 5
Primary Endpoint: Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kuopio University Hospital

Responsible Party

Principal Investigator

Heikki Lopponen

M.D.,Prof.

Kuopio University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids

Time Frame: Various time points up to 5 years hearing age

Secondary Outcomes

To evaluate the differences in balance function(at 3 and 5 year 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 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)