Identity
- Trade Name
- Persona Medical FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors. FDA UDI
- Model / Reference
- Ole Deep CIC Custom Hearing Aid FDA UDI
- Description
- This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851362008315 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- Not 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
No
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
Persona Medical by Persona Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 65fa4422-7788-44e9-ac28-494b8b7d8a11 34 fields · synced Jun 8, 2026