Baha 5 Power, Blonde 95470Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09321502034586), received between Sep 13, 2017 and Sep 13, 2017 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE PATIENT'S AUDIOLOGIST, THE PATIENT REPORTEDLY EXPERIENCED BLEEDING AT THE SITE OF THE PROCESSOR, AND WAS SUBSEQUENTLY TREATED WITH A TOPICAL ANTIBIOTIC OINTMENT. IT WAS REPORTED THAT THE PATIENT WAS WEARING THEIR BAHA PROCESSING DEVICE ON ANOTHER MANUFACTURER'S RIGID METAL HEADBAND, AND THAT THE PATIENT'S IS IMPLANTED WITH ANOTHER MANUFACTURER'S FIXTURE. IT IS UNKNOWN HOW THE PROCESSING DEVICE WAS AFFIXED TO THE HEADBAND, AND WHETHER OR NOT THIS MAY HAVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE PATIENT WILL CONTINUE TO BE CLINICALLY MANAGED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6863763 ↗