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

Assistance Publique - Hôpitaux de Paris

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Deafness

Interventions

bilateral cochlear Implantation in sequentialPROCEDURE

bilateral cochlear Implantation in sequential

bilateral cochlear Implantation in simultaneousPROCEDURE

bilateral cochlear Implantation in simultaneous

Eligibility

Sex: ALLMin age: 8 MonthsMax age: 38 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Measurement of the score of perception of words in open list

Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation

Time frame: 12 months after the implantation

Secondary Outcomes

Measurement of the capability of localization right/left

Time frame: 12 and 24 months after the implantation

Measurement of the level of comprehension and production

Measurement of the level of comprehension and production after 24 months after the implantation

Time frame: 24 months after the implantation

Evaluation of the medical monitoring about the materiovigilance and the eventual complications

Time frame: During all the duration of the study

Measurement of the vestibulometry and of the children's psychomotor development

Time frame: 12 and 24 months after the implantation

Analysis of the parent questionnaires of the quality of life

Time frame: 12 and 24 months after implantation

Data from ClinicalTrials.gov

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