GN Hearing 21455920Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296191895), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryAug 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY SALES OFFICE: PT HAD A REACTION TO THE RECEIVER (SWELLING) ON THE RIGHT SIDE ONLY. LIVELY PROVIDER STATED THAT PT HAD A REACTION FROM THE MP RECEIVER ON THE LH561-DRWC HA. IT ONLY OCCURRED ON THE RIGHT SIDE. PT'S EAR SWELLED (CANAL GOT "PUFFY AND CLOSED OFF") AND THERE WAS A BLOOD-LIKE SUBSTANCE. HCP ALSO MENTIONED PT HAS MS. PT IS AN MD SO IS MANAGING HIS OWN CARE. PT STOPPED WEARING THE RIGHT HEARING AID, PUT ANTIBIOTICS IN HIS EAR, AND THE REACTION STARTED TO CLEAR UP SO PT HAS RESUMED USE OF THE DEVICE. HCP ADVISED IF PAINFUL OR UNCOMFORTABLE TO STOP USE IMMEDIATELY. PT HAS "CONSULTED WITH HIMSELF" AND HAS DECIDED TO CONTINUE USING THE HAS. PT INQUIRED IF THERE IS A PERCENTAGE OF NICKEL. I INFORMED HCP I WILL REQUEST THAT INFORMATION AND FOLLOW-UP WITH HER. HCP IS UNSURE IF PT HAS A NICKEL ALLERGY. COMPLAINT CREATED. ADDITIONAL INFORMATION BY CORPORATE QUALITY: THE RECEIVER IS MADE OF LOW-SULFUR STAINLESS STEEL 316L, WHICH, EVEN THOUGH IT CONTAINS NICKEL, SHOULD NOT ELICIT CONTACT DERMATITIS IN PATIENTS WITH SENSITIVITY TO NICKEL.

  Patient problems: Skin Irritation

  MAUDE report 10441318 ↗