Ponto M52657
Ponto M52657 is an anchored bone-conduction hearing implant system (FDA Class II; FDA product code LXB, Hearing Aid, Bone Conduction) made by Oticon Medical AB, listed in FDA GUDID since 11 Nov 2016 (UDI-DI 05712149011919), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05712149011919 | Date11 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 05712149011919
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ponto
- Generic name
- Anchored bone-conduction hearing implant system
- Model / Ref / Catalog
- M52657
- Primary DI / UDI-DI
- 05712149011919
- FDA product code
- LXB
- GMDN term
- Anchored bone-conduction hearing implant system
- Device class
- Class II
- Regulation number
- 874.3302
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- Bone Conduction Hearing Aid (G41157) by ZDEER TECHNOLOGY (HENAN) CO., LTD
- ADHEAR User Kit, Terra Brown 38198 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Baha SoundArc Extra Small P1324401 by Cochlear Bone Anchored Solutions AB
- BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT by Cochlear Americas
- Cochlear Baha SoundArc by Cochlear Americas
- BAHA DIVINO by Entific Medical Systems, Inc.
- SOUNDBITE HEARING SYSTEM BY SONITUS by Sonitus Medical, Inc.
- TRANSEAR BONE CONDUCTION HEARING AID by Ear Technology Corporation
- ADHEAR Audio Processor (701), Terra Brown, lock 40432 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Baha SoundArc Large P807177 by Cochlear