NCT01499901

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 8 Months – 38 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Deafness

Interventions

Type	Name	Description
PROCEDURE	bilateral cochlear Implantation in sequential	bilateral cochlear Implantation in sequential
PROCEDURE	bilateral cochlear Implantation in simultaneous	bilateral cochlear Implantation in simultaneous

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-12-26
• Last updated: 2012-11-19