VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Basic Information
- Primary DI
- 00195949149955
- Basic UDI-DI Code
- 0195949HTTV
- Reference
- Hearing Test 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 Apple Hearing Test Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is an over-the-counter air-conduction hearing assessment intended to profile hearing ability and to produce an audiogram without the assistance of a hearing healthcare professional. The Apple Hearing Test Feature is intended for use by individuals 18 years of age or older. Target Population and Intended Users: The feature is indicated as an over-the-counter air-conduction hearing assessment to profile hearing ability and produce an audiogram for individuals 18 years of age or older.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12149092 | VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).