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Phonak Brand
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 054-0953Model Sonova in ear hearing solution assistant tools
by Sonova AG
Identity
- Trade Name
- Lyric SoundLync Kit EUDAMEDPhonak Brand FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Sonova in ear hearing solution assistant tools EUDAMEDLyric SoundLync kit FDA UDI
- Model / Reference
- 054-0953 EUDAMEDFDA UDISonova in ear hearing solution assistant tools EUDAMED
- Description
- Lyric SoundLync kit FDA UDI
Identifiers
- Catalog Number
- 054-0953 FDA UDI
- Primary DI / UDI-DI
- 07613389392654 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389IAHSATH8 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Category: Hearing aid/implant system remote control
Phonak Brand by Sonova AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- 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
- Bernafon — Bernafon, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
Sources (2)
- FDA UDI 5209e9a9-51da-4823-bdc7-5093d21b1395 35 fields · synced Jun 11, 2026
- EUDAMED 14b226e2-8c88-419a-9ef5-17cc45bd15c5 61 fields · synced Jun 11, 2026