Children's Bilateral Cochlear Implantation in Finland

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Deafness Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bilateral cochlear implant

Group Type ACTIVE_COMPARATOR

cochlear implant

Intervention Type DEVICE

Multichannel Nucleus cochlear implant

cochlear implant and hearing aid

Group Type ACTIVE_COMPARATOR

cochlear implant

Intervention Type DEVICE

Multichannel Nucleus cochlear implant

hearing aid

Intervention Type DEVICE

Phonak hearing aid

bilateral hearing aid

Group Type ACTIVE_COMPARATOR

hearing aid

Intervention Type DEVICE

Phonak hearing aid

Interventions

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cochlear implant

Multichannel Nucleus cochlear implant

Intervention Type DEVICE

hearing aid

Phonak hearing aid

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No