GN Hearing 20619920Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296094189), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.

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.

• InjurySep 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  DESCRIPTION OF EVENT FROM INITIAL REPORTER: PATIENT HAD TO SEEK MEDICAL CARE BECAUSE DOME BECAME LODGED TOO DEEPLY IN EAR. DURING EXTRACTION, PATIENT BEGAN TO BLEED FROM HIS EAR AND HAD TO GET A PRESCRIPTION FOR VITAMIN K TO QUELL THE BLEEDING AS HE IS UNDERGOING LEUKEMIA TREATMENT. ACCORDING TO QUESTIONNAIRE: PATIENT REALIZED SUNDAY MORNING THAT SOMETHING WAS WRONG IN HIS EAR. HE AND HIS WIFE ATTEMPTED TO LOCATE DOME BUT COULD NOT. MADE APPOINTMENT FOR DOCTOR VISIT ON MONDAY AFTERNOON SO HIS REGULAR DOCTOR COULD LOOK AT IT. IT TOOK AROUND 90 MINUTES FOR HER TO GET THE DOME OUT OF HIS EAR. DURING EXTRACTION, THE DOCTOR SCRATCHED THE EAR CANAL AND THE PATIENT BEGAN TO BLEED AND HAD TO GET A PRESCRIPTION FOR VITAMIN K TO QUELL THE BLEEDING AS HE IS UNDERGOING LEUKEMIA TREATMENT. EAR IS STILL SORE. PATIENT IS NERVOUS ABOUT REPLACING HIS DOME AND CONTINUING TO WEAR THE HEARING AIDS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12504565 ↗