Ponto M52638
Ponto M52638 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 05712149011742), 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 | Number05712149011742 | Date11 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 05712149011742
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- Withdrawn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
- M52638
- Primary DI / UDI-DI
- 05712149011742
- 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).
- OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc.
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- Cordelle II Sound Processor by Cochlear Americas
- ADHEAR Adhesive Adapters, brown, 15 pcs. 34690 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON by Audifon-USA, Inc.
- AUDIANT BONE CONDUCTOR OR A.B.C. by Xomed, Inc.
- COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT by Cochlear Americas
- BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. by Entific Medical Systems, Inc.
- BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) by Entific Medical Systems, Inc.