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Eur Ann Otorhinolaryngol Head Neck Dis ; 137 Suppl 1: S27-S35, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32763084

RESUMO

OBJECTIVE: Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label. MATERIAL AND METHODS: This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the "Haute Autorité de santé (HAS)" in 2012. The data was collected from the "EPIIC" registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded. RESULTS: In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients. CONCLUSION: These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.


Assuntos
Implante Auditivo de Tronco Encefálico/estatística & dados numéricos , Implante Coclear/estatística & dados numéricos , Implantes Cocleares/estatística & dados numéricos , Perda Auditiva/reabilitação , Seleção de Pacientes , Sistema de Registros/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Audiometria da Fala/métodos , Criança , Pré-Escolar , Implante Coclear/efeitos adversos , Implantes Cocleares/efeitos adversos , Feminino , França/epidemiologia , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Uso Off-Label/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Período Pós-Operatório , Cuidados Pré-Operatórios , Estudos Prospectivos , Qualidade de Vida , Adulto Jovem
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