NCT00960102

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

13.4 years

First QC Date

August 14, 2009

Last Update Submit

August 16, 2022

Conditions

DeafnessHearing Loss

Keywords

cochlear implantationhearing aid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • To evaluate the differences in balance function

    at 3 and 5 year age

Study Arms (3)

bilateral cochlear implant

ACTIVE COMPARATOR
Device: cochlear implant

cochlear implant and hearing aid

ACTIVE COMPARATOR
Device: cochlear implantDevice: hearing aid

bilateral hearing aid

ACTIVE COMPARATOR
Device: hearing aid

Interventions

cochlear implantDEVICE

Multichannel Nucleus cochlear implant

bilateral cochlear implantcochlear implant and hearing aid
hearing aidDEVICE

Phonak hearing aid

bilateral hearing aidcochlear implant and hearing aid

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Otorhinolaryngology, Helsinki University Hospital

Helsinki, Finland

Location

Department of Otorhinolaryngology, Kuopio University Hospital

Kuopio, 70211, Finland

Location

Department of Otorhinolaryngology, Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Department of Otorhinolaryngology, Turku University Hospital

Turku, Finland

Location

Related Publications (1)

  • 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.

    PMID: 34260435DERIVED

MeSH Terms

Conditions

DeafnessHearing Loss

Interventions

Cochlear ImplantsHearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsSensory AidsWearable Electronic Devices

Study Officials

  • Heikki J Löppönen, M.D.,Prof.

    Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland

    STUDY DIRECTOR

  • Taina T Välimaa, Ph.D.

    Faculty of Humanities, Logopedics, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,Prof.

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

August 1, 2009

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

FI(5)