Recommendations of HAS have changed, the study is now useless

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.

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