Identity
- Trade Name
- Persona Medical FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs. FDA UDI
- Model / Reference
- Sombra 9S FDA UDI
- Description
- OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851362008537 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, behind-the-ear
Persona Medical by Persona Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Amplifon — Sonova AG · Class II
- Phonak Naída L30-SP — Sonova AG · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Persona Medical
Sources (1)
- FDA UDI 6c02994d-dcd9-4d19-a499-285f623f356a 33 fields · synced Jun 8, 2026