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Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00960102
Recruitment Status : Unknown
Verified August 2015 by Heikki Lopponen, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : August 17, 2009
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation in Finnish children.

Condition or disease Intervention/treatment Phase
Deafness Hearing Loss Device: cochlear implant Device: hearing aid Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Study Start Date : August 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: bilateral cochlear implant Device: cochlear implant
Multichannel Nucleus cochlear implant
Active Comparator: cochlear implant and hearing aid Device: cochlear implant
Multichannel Nucleus cochlear implant
Device: hearing aid
Phonak Valeo hearing aid
Active Comparator: bilateral hearing aid Device: hearing aid
Phonak Valeo hearing aid

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To compare post-operative speech perception ability, language acquisition, and speech production [ Time Frame: Various time points up to 5 years hearing age ]
  2. To compare speech recognition performance [ Time Frame: Various time points up to 5 years hearing age ]
  3. Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment [ Time Frame: Various time points up to 5 years hearing age ]
  4. To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ]
  5. To evaluate the differences in balance function [ Time Frame: at 3 and 5 year age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960102

Contact: Heikki J Löppönen, M.D.,Prof. +35817172508 heikki.lopponen@kuh.fi
Contact: Taina T Välimaa, Ph.D. +3588553 3396 taina.valimaa@oulu.fi

Department of Otorhinolaryngology, Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Antti Aarnisalo, M.D.       antti.aarnisalo@hus.fi   
Principal Investigator: Antti Aarnisalo, M.D.         
Department of Otorhinolaryngology, Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Antti Hyvärinen, M.D.    +35817173311    antti.hyvarinen@kuh.fi   
Principal Investigator: Antti Hyvärinen, M.D.         
Department of Otorhinolaryngology, Oulu University Hospital Recruiting
Oulu, Finland
Contact: Mirja Luotonen, M.D.       mirja.luotonen@ppshp.fi   
Principal Investigator: Mirja Luotonen, M.D.         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Juha-Pekka Vasama, M.D., Ph.D.       juha-pekka.vasama@pshp.fi   
Principal Investigator: Juha-Pekka Vasama, M.D.,Ph.D.         
Department of Otorhinolaryngology, Turku University Hospital Recruiting
Turku, Finland
Contact: Jaakko Salonen, M.D.       jakko.salonen@tyks.fi   
Principal Investigator: Jaakko Salonen, M.D.         
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
Hospital District of Helsinki and Uusimaa
Helsinki University
Oulu University Hospital
University of Oulu
Turku University Hospital
Tampere University Hospital
Study Director: Heikki J Löppönen, M.D.,Prof. Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
Principal Investigator: Taina T Välimaa, Ph.D. Faculty of Humanities, Logopedics, University of Oulu, Finland
More Information

Responsible Party: Heikki Lopponen, M.D.,Prof., Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00960102     History of Changes
Other Study ID Numbers: KUH5551819
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Heikki Lopponen, Kuopio University Hospital:
cochlear implantation

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms