Identity
- Trade Name
- RXEars FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals. FDA UDI
- Model / Reference
- BT1R FDA UDI
- Description
- Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851362008452 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, behind-the-ear 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
Yes
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
Yes
FDA UDI
Category: Air-conduction hearing aid, behind-the-ear
RXEars by Persona Medical — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Persona Medical
Sources (1)
- FDA UDI 432b22b6-37c2-4ebc-a4a1-3c59ee2e1f1d 33 fields · synced Jun 1, 2026