PFOClass 2
Active Implantable Bone Conduction Hearing System
FDA adverse event reports and recall history for active implantable bone conduction hearing system (product code PFO), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 3,437
- Deaths
- 1
- Injuries
- 3,067
- Malfunctions
- 369
Reports per year
218
2519
7020
23721
30622
47323
71224
1,00825
60426
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor active implantable bone conduction hearing system automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.