NIX

Hearing Aid, Air Conduction, Transcutaneous System

产品代码: NIX
器械名称: Hearing Aid, Air Conduction, Transcutaneous System
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 874.3950
FDA 专业组: Ear, Nose, Throat
上市路径: 需提交 510(k) 上市前通告
标记: 属植入器械
该代码近三年的 510(k): 2 件

FDA 分类定义

The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： NIX

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。