GN Hearing 22015676Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296221820), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  02JUN2023 HEARING CARE PROVIDER (HCP) REPORTED THAT FOR A PATIENT A DOME TIP AND RED PART OF RECEIVER TIP IN EAR THAT REQUIRES MEDICAL STAFF TO REMOVE. INCIDENT HAPPENED (B)(6) 2023 PATIENT CALLED (HCP) TODAY TO REPORT. STATED HE HAD CLEANED AND CHANGED DOMES DAY PRIOR, PLACED IN CHARGER OVERNIGHT. WHEN HE AWOKE HE NOTICED MISSING 'TIP' ON R AID AND WENT TO COSTCO HAC WHO CONFIRMED DOME/RECEIVER TIP IN EAR AND REFERRED OUT TO ENT OR URGENT CARE FOR REMOVAL. MEMBER USED URGENT CARE WHO REMOVED IT WITH A TWEEZER WITHOUT ISSUE OR HARM. PATIENT HAS HAD AIDS SINCE (B)(6) 2022 (11MONTH). THIS IS FIRST INCIDENT. PATIENT RECEIVED NEW TIPS AND RECEIVER, DOME AND SPORT LOCK WAS CHANGED AS WELL. HCP WENT OVER PROPER DOME CHANGE AND CLEANING PROCEDURES. NO FURTHER FOLLOW UP EXPECTED.

  Patient problems: Unspecified Ear or Labyrinth Problem

  MAUDE report 17237988 ↗