SCR
- 产品代码
- SCR
- 器械名称
- Air-Conduction Hearing Aid Software
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 874.3335
- 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)
- 5 件
FDA 分类定义
Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.
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 |
|---|---|---|---|---|
| K261187 | 2026-07-31 | Samsung Electronics Co., Ltd. | Hearing Aid Feature | FDA |
| K254044 | 2026-07-13 | Meta Platform Technologies, LLC | Hearing assist | |
| K251208 | 2025-09-26 | Tuned , Ltd. | Tuned Self-Fitting Mobile App | |
| K243150 | 2025-01-31 | Luxottica Group S.P.A. | Nuance Audio Hearing Aid Software | |
| DEN230081 | 2024-09-12 | Apple, Inc. | Hearing Aid Feature (HAF) | — |
FDA 官方分类页： SCR
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。