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Phonak Lyric4
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 078-0067Model Sonova ITE hearing aids
by Sonova AG
Identity
- Trade Name
- Phonak Lyric4 (XXS) EUDAMEDPhonak Lyric4 FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- Sonova ITE hearing aids EUDAMED
- Model / Reference
- Sonova ITE hearing aids EUDAMED078-0067 EUDAMED(XXS) FDA UDI
Identifiers
- Catalog Number
- 078-0067 FDA UDI
- Primary DI / UDI-DI
- 07613389603279 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389LYRY2 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
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: Air-conduction hearing aid, canal
Phonak Lyric4 by Sonova AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, canal.
- Widex — Widex A/S · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Oticon — Oticon A/S · Class II
- GN ReSound — Gn Hearing A/S · Class I
- MICROTECH — Starkey Laboratories Inc. · Class II
- Bernafon — Bernafon, Inc. · Class II
- KIND — Starkey Laboratories 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 2a4b90c7-1346-4e96-9b53-a8c47fc22ad8 33 fields · synced Jun 18, 2026
- EUDAMED 0c0b7275-95d0-4ab8-9dc5-1a4436d2f93e 61 fields · synced Jun 18, 2026