Children's Bilateral Cochlear Implantation in Finland

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00960102

Acronym

FinBiCI

Enrollment

Registered

2009-08-17

Start date

2009-08-31

Completion date

2022-12-31

Last updated

2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Hearing Loss

Keywords

cochlear implantation, hearing aid

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.

Interventions

DEVICEcochlear implant

Multichannel Nucleus cochlear implant

DEVICEhearing aid

Phonak hearing aid

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026