Status:
WITHDRAWN
Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Deafness
Eligibility:
All Genders
8-38 years
Phase:
PHASE3
Brief 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 bef...
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 ...
Eligibility Criteria
Inclusion
- Deep bilateral congenital deafness.
- Age at the implantation: from 10 to 40 months, included.
- Criteria for indication of unilateral implantation (those considered by the HAS (2007))
- Deep bilateral deafness
- Threshold prosthetic equal or above 60 dB
- Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus)
- No medical nor radiologic contraindication
- Entitled child for welfare (excepted medical state aids)
- French spoken at home
- Agreement firms for the study by the two genitors
Exclusion
- Neurologic and/or psychiatric known related disorders
- Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.
- Progressive or acquired deafness
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01499901
Start Date
January 1 2012
End Date
January 1 2012
Last Update
November 19 2012
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