Approval for neuro cochlear implant system (ncis)the neuro cochlear implant system (ncis) is indicated for individuals eighteen (18) years of age or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). Severe-to-profound hearing loss is determined by a pure-tone average (pta) superior or equal (? ) to 70 db hl at 500, 1000 and 2000 hz. Limited benefit from amplification is defined by scores of 50% or less on hearing in noise test (hint) sentences in quiet or noise, in the best-aided listening condition. Unless already appropriately fitted with hearing aids, it is recommended that candidates undergo a hearing aid trial period of three (3) months.
|Device||Neuro Cochlear Implant System|
|Generic Name||Implant, Cochlear|
|Advisory Committee||Ear Nose & Throat|
|Applicant Address||Oticon Medical 2720 Chemin Saint Bernard vallauris 06220|
|Supplement Number||Date||Supplement Type|