HEARING AIDS - OTHER
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Basic Information
- Primary DI
- 00195949149931
- Basic UDI-DI Code
- 0195949HAFCR
- Reference
- Hearing Aid Feature 1.X
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Apple Inc.
Additional Description
The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing professional. The device is intended for Over-the- Counter use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Y214599 | HEARING AIDS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).