Identity
- Trade Name
- TruHearing FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- APP TRUHEARING FDA UDI
- Model / Reference
- TruHearing App FDA UDI
- Description
- APP TRUHEARING FDA UDI
Identifiers
- Catalog Number
- 10996369 FDA UDI
- Primary DI / UDI-DI
- 05714880113150 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hearing aid/implant system remote control
TruHearing by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid/implant system remote control.
- Sonic — Sbo Hearing A/S · Class II
- Philips — Sbo Hearing A/S · Class II
- Phonak Brand — Sonova AG · Class I
- Bernafon — Bernafon, Inc. · Class II
- Bernafon — Sbo Hearing A/S · Class II
- Neutral — Sbo Hearing A/S · Class II
- Lehiso — Sbo Hearing A/S · Class II
- Widex — Widex A/S · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- WS Audiology USA, Inc.
Sources (1)
- FDA UDI 5a03fa6b-64de-4e7c-b746-2be8049a8f5d 35 fields · synced Jun 8, 2026