Phonak 050-0237-P5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613275475881), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 16, 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.

• MalfunctionApr 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAS BEEN USING PHONAK AUDÉO B90-R HEARING AID WITH A CUSTOM CSHELL EARPIECE. CERUSTOP BUSHING OF THE EARPIECE GOT DISENGAGED FROM THE CSHELL WHILE IN USE AND REMAINED IN THE PATIENT'S EAR. THE PATIENT REQUIRED MEDICAL INTERVENTION UNDER GENERAL ANESTHESIA TO REMOVE THE PART FROM THE EAR. GENERAL ANESTHESIA WAS REQUIRED DUE TO THE FACT THAT THE PART WAS LOCATED TOO CLOSE TO THE EARDRUM IN THE EAR CANAL. THE PATIENT DID NOT SUFFER ANY INJURY AS THE RESULT OF THIS EVENT. THE PATIENT HAS SUCCESSFULLY RECOVERED FROM THE INTERVENTION AND RESUMED THE USE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14218880 ↗