MAH
11 FDA 510(k) clearances · Product code
124 daysmedian time to decision
163 days90th percentile
11clearances measured
FDA profile
- Official device name
- Hearing Aid, Bone Conduction, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3302
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 709 · 2022: 711 · 2023: 742 · 2024: 621 · 2025: 569 · 2026: 285
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Ponto Bone Anchored Hearing System, MONO Surgery Kit (K203807) | Oticon Medical AB | 2021-03-03 |
| BA310 Abutment, BIA310 Implant/Abutment (K182116) | Cochlear Americas | 2018-12-19 |
| Ponto Bone Anchored Hearing System (K152820) | Oticon Medical AB | 2016-01-22 |
| Ponto bone anchored hearing system (K152067) | Oticon Medical AB | 2015-11-23 |
| BA400 14mm Abutment (K150555) | Cochlear Americas | 2015-07-15 |
| Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678) | Oticon Medical AB | 2015-01-21 |
| COCHLEAR BAHA IMPLANT SYSTEM (K121317) | Cochlear Americas | 2012-10-12 |
| PONTO BONE ANCHORED HEARING SYSTEM (K121228) | Oticon Medical AB | 2012-09-07 |
| OBC BONE ANCHORED HEARING SYSTEM (K112053) | Oticon Medical AB | 2011-11-18 |
| BAHA CORDELLE II (K080363) | Cochlear Bone Anchored Systems AB | 2008-04-10 |
| BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (K984162) | Nobelpharma USA, Inc. | 1999-06-28 |
Track MAH automatically
Every clearance here is in the API, with alerts when new ones post.