ABSTRACT
Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016.
Subject(s)
Auditory Brain Stem Implants/statistics & numerical data , Cochlear Implants/statistics & numerical data , Registries/statistics & numerical data , Advisory Committees/organization & administration , Age Factors , Aged , Aged, 80 and over , Auditory Brain Stem Implants/economics , Cochlear Implantation/statistics & numerical data , Cochlear Implants/economics , Computer Security , Databases as Topic , Device Approval/legislation & jurisprudence , Device Removal/statistics & numerical data , France , Guidelines as Topic/standards , Health Care Sector/economics , Health Care Sector/legislation & jurisprudence , Humans , Infant , Infant, Newborn , Insurance, Health, Reimbursement , Quality Control , Reference Standards , Time FactorsABSTRACT
INTRODUCTION: The auditory brainstem implant (ABI) is a neuroprosthetic device that provides sound sensations to individuals with profound hearing loss who are not candidates for a cochlear implant (CI) because of anatomic constraints. Herein we describe the ABI for family physicians. METHODS: PubMed was searched to identify articles relevant to the ABI, as well as articles that contain outcomes data for pediatric patients (age <18 years) who have undergone ABI surgery. RESULTS: The ABI was originally developed for patients with neurofibromatosis type 2 (NF2) who become deaf from bilateral vestibular schwannomas. Over the past decade, indications for an ABI have expanded to adult patients without tumors (without NF2) who cannot receive a CI and children with no cochlea or cochlear nerve. Outcomes among NF2 ABI users are modest compared to cochlear implant patients, but recent studies from Europe suggest that some non-tumor adult and pediatric ABI users achieve speech perception. CONCLUSION: The ABI is a reasonable surgical option for children with profound hearing loss due to severe cochlear or cochlear nerve deformities. Continued prospective data collection from several clinical trials in the U.S. will provide greater understanding on long term outcomes that focus on speech intelligibility.
