Children's Bilateral Cochlear Implantation in Finland

Hearing Loss Clinical Trial

— FinBiCI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00960102
• Other study ID #: KUH5551819
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2009
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• cochlear implant
Multichannel Nucleus cochlear implant
• hearing aid
Phonak hearing aid

Locations

Country	Name	City	State
Finland	Department of Otorhinolaryngology, Helsinki University Hospital	Helsinki
Finland	Department of Otorhinolaryngology, Kuopio University Hospital	Kuopio
Finland	Department of Otorhinolaryngology, Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Department of Otorhinolaryngology, Turku University Hospital	Turku

Sponsors (8)

Lead Sponsor	Collaborator
Kuopio University Hospital	Hospital District of Helsinki and Uusimaa, Oulu University Hospital, Tampere University Hospital, Turku University Hospital, University of Eastern Finland, University of Helsinki, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare post-operative speech perception ability, language acquisition, and speech production		Various time points up to 5 years hearing age
Secondary	To compare speech recognition performance		Various time points up to 5 years hearing age
Secondary	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
Secondary	To evaluate operative and post-operative complications, side-effects and device failures		Various time points up to 5 years hearing age
Secondary	To evaluate the differences in balance function		at 3 and 5 year age