GN Hearing 20291400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296140275), received between Sep 16, 2020 and May 31, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  (B)(4): IT WAS REPORTED- HCP REPORTS "ALLERGIC REACTION" AND "FUNGAL REACTION" TO SILICONE DOME (TULIP) AS WELL AS ACRYLIC EAR MOLD (SN: (B)(4). HCP REPORTS THAT THE PATIENT'S RIGHT EAR IS MUCH MORE SENSITIVE THAN THE LEFT EAR. HCP REPORTS THE PATIENT FIRST REPORTING AN ISSUE WITH THE ACRYLIC EM (B)(6) 2021("PAIN AND BURNING"). AT THAT TIME SHE DID NOT CALL IN BUT CHANGED THE EM TO A SILICONE TULIP DOME. SHE REFERRED ON TO ENT. HCP REPORTED THAT PATIENT STOPPED WEARING ANYTHING(I.E., DOME, EM) ON THE RIGHT SIDE AND HE HAS NOTICED SLIGHT IMPROVEMENT. JUST RECENTLY ENT SHARED WITH PATIENT THAT A FUNGAL TEST REVEALS THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". HCP SHARED THAT ENT STATED THE FUNGAL INFECTION WAS 'CANDIDA PARATSILOSIS'. HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. SPOKE WITH VIKKI IN TFTS AS HCP INQUIRED ON WHAT WE CAN DO IF THIS PATIENT HAS AN ALLERGY TO SILICONE AND ACRYLIC. VIKKI RECOMMENDED THAT WE TRY AND DO A "MATTE FINISH" TO SEE IF THAT WERE ANY BETTER. HOWEVER- IT WAS EXPLAINED TO THE HCP AND THE PATIENT (AS HE WAS ON THE CALL) THAT THE UNDERLYING MATERIAL OF THE EM IS

  Patient problems: Fungal Infection; Hypersensitivity/Allergic reaction

  MAUDE report 14546213 ↗
• InjurySep 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY THE LOCAL SALES OFFICE: EAR MOLD REMAKE CAUSES ALLERGIC REACTION. FIRST SET OF EM'S WERE FINE - THEN THE REMAKE CAUSED ALLERGIC REACTION IN THE EARS. AFTER FITTING OF REMAKE EM'S, MEMBER COMPLAINED OF ALLERGIC REACTION CAUSING REDNESS AND FLAKING IN EAR CANAL. PICKED UP REMAKE ON (B)(6) 2020 AND WORE FOR 4 DAYS. THEN MEMBER HAD TO STOP WEARING THEM. REDNESS AND FLAKING IN THE EAR CANAL. 4 DAYS AFTER WEARING REMADE EM'S ((B)(6) 2020). LEFT EAR HAS HEALED BUT RIGHT EAR IS STILL RED AND A BIT FLAKY. MEMBER SAW DERMATOLOGIST AND MEDICATION PRESCRIBED AND MEMBER WAS TOLD TO STOP WEARING EM'S.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Skin Irritation

  MAUDE report 10539253 ↗