Identity
- Trade Name
- SoniTon EUDAMED
- Model / Reference
- HI (BTE) EUDAMED278885 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464156276 EUDAMED
- Basic UDI-DI
- 57144640-HI-00053-RB EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Air-conduction hearing aid, receiver-in-canal
SoniTon, a Class IIa implantable hearing aid, is a medical device designed to enhance auditory perception and improve speech recognition for individuals with hearing loss. With its advanced technology and user-friendly interface, SoniTon provides clear and intelligible communication, enabling users to connect with others more effectively.
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Also classified as Air-conduction hearing aid, receiver-in-canal.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00053-RB | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (1)
- EUDAMED 00138e40-8d8d-46d0-a622-cee94ef63201 61 fields · synced Jul 17, 2026