Bilateral cochlear implantation in children; a pragmatic randomised controlled trial

Phase 3

Completed

Conditions: Deafness
Hearing loss
10019243

Registration Number: NL-OMON36764

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

- Cochlear implant candidacy, according to the current criteria
- Age < 2 years
- Written informed consent by parents or guardians
- General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
- Patients covered by the Dutch health insurance

Exclusion Criteria

- General health not allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
- Abnormal cochlear anatomy in one or both ears.
- Chronic ear infection in one or both ears.
- Previous cochlear implant experience.
- Disability which could interfere with the completion of the tests.
- Deafness caused by meningitis, otosclerosis or Cogans syndrome.
- Severely visually impaired

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the performance on the TAIT video analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be the performance on:<br /><br>- soundlocalization tests<br /><br>- auditory perception measures<br /><br>- electrophysiology tests: Auditory brainstem response (ABR) and Cortical<br /><br>auditory evoked potentials (CAEP)</p><br>