Clinical trial NCT00960102: Children's Bilateral Cochlear Implantation in Finland
Official title: Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness
Hearing Loss
Keywords: cochlear implantation
hearing aid
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: Hospital District of Helsinki and Uusimaa
name: University of Helsinki
name: Oulu University Hospital
name: University of Oulu
name: Turku University Hospital
name: Tampere University Hospital
First posted: 2009-08-17
Enrollment: 40
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
timeFrame: Various time points up to 5 years hearing age
Secondary outcomes:
measure: To compare post-operative speech perception ability, language acquisition, and speech production
timeFrame: Various time points up to 5 years hearing age
measure: To compare speech recognition performance
timeFrame: Various time points up to 5 years hearing age
measure: Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment
timeFrame: Various time points up to 5 years hearing age
measure: To evaluate operative and post-operative complications, side-effects and device failures
timeFrame: Various time points up to 5 years hearing age
measure: To evaluate the differences in balance function
timeFrame: at 3 and 5 year age
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Otorhinolaryngology, Helsinki University Hospital
city: Kuopio
country: Finland
facility: Department of Otorhinolaryngology, Kuopio University Hospital
city: Oulu
country: Finland
facility: Department of Otorhinolaryngology, Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Department of Otorhinolaryngology, Turku University Hospital
Study officials:
affiliation: Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
name: Heikki J Löppönen, M.D.,Prof.
role: STUDY_DIRECTOR
affiliation: Faculty of Humanities, Logopedics, University of Oulu, Finland
name: Taina T Välimaa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valimaa TT, Kunnari S, Aarnisalo AA, Dietz A, Hyvarinen A, Laitakari J, Mykkanen S, Rimmanen S, Salonen J, Sivonen V, Tennila T, Tsupari T, Vikman S, Virokannas N, Laukkanen-Nevala P, Tolonen AK, Tuohimaa K, Lopponen H. Spoken Language Skills in Children With Bilateral Hearing Aids or Bilateral Cochlear Implants at the Age of Three Years. Ear Hear. 2022 Jan/Feb;43(1):220-233. doi: 10.1097/AUD.0000000000001092.