Assuntos
Coleta de Dados/normas , Vigilância de Produtos Comercializados/métodos , Próteses e Implantes/normas , Sistema de Registros/normas , Comitês Consultivos , Ensaios Clínicos como Assunto , Implantes Cocleares/efeitos adversos , Implantes Cocleares/classificação , Implantes Cocleares/normas , Coleta de Dados/métodos , Aprovação de Equipamentos , Diagnóstico , França , Humanos , Reembolso de Seguro de Saúde , Legislação de Dispositivos Médicos , Seleção de Pacientes , Próteses e Implantes/efeitos adversos , Próteses e Implantes/classificação , Controle de Qualidade , Qualidade de Vida , Medição de Risco , Resultado do TratamentoRESUMO
Cochlear implant have been proven to be safe and cost-effective in deafened adults. Generally, a single cochlear implants is proposed providing monaural audition. Some teams have published interesting results in patients wearing two cochlear implants. The cost of the surgical procedure is greatly increased for bilateral implantation. In an attempt to provide patients with binaural hearing and a better chance to improve their capacity for frequency discrimination without an excessive increase in cost, we developed an new concept and design for binaural cochlear implants. The aim of the present study was to establish the surgical technique for binaural cochlear implantation with a single internal receptor-stimulator. We report descriptive data on surgical procedures performed in two cadavers and in two deafened adults. The special implant is composed of a single receptor-stimulator and two electrode arrays: a short one implanted into the ipsilateral ear and a long one in the contralateral ear. A specially designed tool for endoscopic facial lifting was used to create subcutaneous tunnels from the ipsilateral to the contralateral ear. Insertion into cochleas was unremarkable. Additional time for surgery (compared with mean operative time for routine adult surgery in our unit), and surgical details are discussed. Binaural cochlear implantation is feasible, easy and not very time consuming. Studies are in progress to determine patient benefit. Obtaining auditory brainstem evoked potentials electrically in patients with binaural cochlear implants is possible and provides an interesting mode for in vivo analysis of the long-term effect of profound/total deafness on neural transmission. In our patients, results have demonstrated that neural response properties in auditory pathways are negatively related to duration of deafness.