真耳测试仪产品技术审评要点探讨

Discussion on Key Points of Technical Evaluation of Ear Testers

真耳分析作为一项助听器精准调节的评估手段在临床上得到越来越广泛的应用。但真耳测试仪产品没有相应的审评规范、产品标准、临床适应证等方面的研究。本文基于安全性和有效性审查原则,针对真耳测试仪产品技术审评工作中的主要关注项目,包括产品结构组成、主要风险、性能要求、临床评价等进行了探讨,以期为该类产品的设计开发人员和审评注册人员提供参考。

Real-ear measurements,as an evaluation method for precise adjustment of hearing aids,is becoming increasingly widely used in clinical practice.However,there are no corresponding evaluation standards,product standards,clinical indications,and other research related to real ear testing equipment products.This article is based on the principles of safety and effectiveness review,and discusses the main focus items in the technical evaluation of real ear testing equipment products,including product structure composition,major risks,performance requirements,clinical evaluation,etc.,in order to provide reference for design and development personnel and review and registration personnel of such products.