Identity
- Trade Name
- Baha FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Cochlear Baha Control App for iOS FDA UDI
- Model / Reference
- 95459 FDA UDI
- Description
- Cochlear Baha Control App for iOS FDA UDI
Identifiers
- Catalog Number
- 95459 FDA UDI
- Primary DI / UDI-DI
- 09321502036382 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hearing aid/implant system remote control
Baha by Cochlear Bone Anchored Solutions AB — 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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 3f1c4377-018f-4416-8b4d-5b0d1baa8f9e 35 fields · synced May 30, 2026