Children's Bilateral Cochlear Implantation in Finland

Not Applicable

• Conditions: Hearing Loss; Deafness
• Interventions: Device: cochlear implant; Device: hearing aid

• Registration Number: NCT00960102
• Lead Sponsor: Kuopio University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cochlear implant and hearing aid	hearing aid	-
cochlear implant and hearing aid	cochlear implant	-
bilateral cochlear implant	cochlear implant	-
bilateral hearing aid	hearing aid	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the differences in balance function	at 3 and 5 year 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
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

Trial Locations

Locations (5)

Department of Otorhinolaryngology, Turku University Hospital; 🇫🇮 Turku, Finland

Department of Otorhinolaryngology, Oulu University Hospital; 🇫🇮 Oulu, Finland

Department of Otorhinolaryngology, Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Department of Otorhinolaryngology, Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland