Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

Kuopio University Hospital

Status: Active, not recruiting

Conditions: Hearing Loss; Deafness

Treatments: Device: cochlear implant; Device: hearing aid

Study type: Interventional

Funder types: Other

Identifiers

NCT00960102

KUH5551819

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

bilateral cochlear implant

Active Comparator group

Treatment:

Device: cochlear implant

cochlear implant and hearing aid

Active Comparator group

Treatment:

Device: cochlear implant

Device: hearing aid

bilateral hearing aid

Active Comparator group

Treatment:

Device: hearing aid