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/AEMS corpus and the live FDA recall database.
- Total reports
- 3,346
- Deaths
- 1
- Injuries
- 2,986
- Malfunctions
- 359
Reports per year
218
2519
7020
23721
30622
47323
71224
1,00825
51326
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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