骨导式助听器产品技术审评要点探讨  

Discussion on key points for technical evaluation of bone guided hearing aids

作　　者：何佳俊 于庆洁 垢德双 He Jiajun;Yu Qingjie;Gou Deshuang(Tianjin Center for Medical Device Evaluation and Inspection,Tianjin 300000,China)

机构地区：[1]天津市医疗器械审评查验中心,天津300000

出　　处：《国际生物医学工程杂志》2024年第3期300-304,共5页International Journal of Biomedical Engineering

摘　　要：助听器是听力补偿的一种重要手段。近年来,随着新技术、新功能的更新迭代,骨导式助听器的发展日新月异,各种新产品不断涌现。但目前该产品缺少相应的审评技术规范,致使产品在注册上市、质量控制、审评尺度等方面存在审评标准不一的情况。对骨传导助听器的产品情况进行介绍,并针对骨导式助听器技术的审评要点包括主要风险、性能要求、临床评价等进行探讨,以期为该类产品的企业设计开发人员和审评注册人员提供参考。Bone-guided hearing aids are an important means of compensating for hearing loss.In recent years,with the advancement and iteration of new technologies and functions,the development of bone-guided hearing aids has been progressing rapidly,resulting in the constant emergence of various new products.However,the current lack of corresponding evaluation standards for this product has led to difficulties in registration,marketing,quality control,and evaluation standards.This study focuses on the technical evaluation perspective and elaborates on the main points of focus in technical evaluation work,such as product structure composition,main risks,performance requirements,and clinical evaluation.The aim is to provide a basis for the design and development,production,registration,use,and post-market supervision of the product.

关 键 词：医疗器械 助听器 骨传导 技术审评 

分 类 号：TH785.1[机械工程—仪器科学与技术]