Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children — Cochleo  

Deafness Clinical Trial

Official title: Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test

Status Withdrawn

Clinical Trial Summary

In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.

Clinical Trial Description

French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness

• NCT number: NCT01499901
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2012
• Completion date: January 2012