GN Hearing 20782602Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296099276), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryDec 16, 2022Off-Label Use; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Off-Label Use; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  MANUFACTURER REF: SF #(B)(4). IT WAS REPORTED- 'PATIENT SWALLOWED AGXR Q761 DRWC; ER REQUESTING INTERNAL/EXTERNAL MATERIAL LIST OF HEARING AID, SUREFIT 2 RECEIVER, DOME. HCP CALLED TO REPORT A PATIENT OF HERS HAD SWALLOWED HER HEARING AID. THE PATIENT WAS AT HER ASSISTED LIVING RESIDENCE WHERE HER DAUGHTER TOOK HER TO THE EMERGENCY ROOM (ER) DEPARTMENT. THE PATIENT'S DAUGHTER CALLED HCP STATING THAT THE ER DOCTORS WERE REQUESTING THE MATERIALS IN OUR HEARING AIDS/RECEIVERS/DOMES. THE PATIENT'S HEARING AID DID HAVE A LITHIUM-ION BATTERY. THE HCP SAID THEY SPECIFICALLY WANTED TO KNOW ABOUT THE METALS INTERNALLY/EXTERNALLY AND ANY METAL INTERNAL COMPONENTS. HCP CALLED BACK PATIENT'S DAUGHTER TO DISCUSS LI BATTERY. PATIENT'S DAUGHTER SHARED THAT THEY CONFIRMED VIA X-RAY THAT THE HEARING AID WAS "IN HER STOMACH/INTESTINES" AND THAT "SHE IS HAVING IT REMOVED FIRST THING TOMORROW MORNING ((B)(6) 2022). THE HCP STATED THAT DOES NOT THINK THAT THE PATIENT BIT INTO OR CHEWED THE HEARING AID BUT THAT IT WAS FULLY SWALLOWED. SHE HAD LIMITED INFORMATION ABOUT THE DETAILS OF THE OCCURRENCE. A MATERIALS LIST HAS BEEN SENT TO ER'. ON (B)(6) 2022, IT WAS REPORTED- PATIENT IS DOING GOOD. SHE CAME IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994192 ↗