QUH
- 产品代码
- QUH
- 器械名称
- Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 874.3325
- FDA 专业组
- Ear, Nose, Throat
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 10 件
FDA 分类定义
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
该代码近三年的 510(k)（5 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K254108 | 2026-06-25 | GN Hearing A/S | Jabra Enhance Select Self-fit (Jabra Enhance Select | |
| K233747 | 2024-03-15 | Concha Labs | Concha Sol Hearing Aids (CL-1001) | |
| K233464 | 2024-02-09 | Wsaud A/S | WSA Self-Fitting Hearing Aid Gen 2 | |
| K231550 | 2023-10-26 | Soundwave Hearing, LLC | Sontro® OTC Hearing Aids (AI) | |
| K221052 | 2023-09-25 | Huizhou Jinghao Medical Technology Co. | Self-Fitting hearing aids |
FDA 官方分类页： QUH
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。