GN Hearing 21587600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708296200320), received between Aug 24, 2022 and Mar 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Overheating of Device; Overheating of Device

  ON 21 FEBRUARY 2023, HCP REPORTED THAT AN END USER REPORTED THE FOLLOWING HAPPENS WITH THEIR PREMIUM CHARGER: "END OF CHARGER THAT PLUGS INTO, IT BURNT, IT BURNT A HOLE IN IT.". WHEN THE HCP ASKED WHERE THEY REPLIED: "THE PLUG ITSELF.". THEY END USER IMPLIED IT IS THE PLUG/AC ADAPTER (BRICK THAT THE USB PLUGS INTO AND ALSO CONNECTS TO THE WALL OUTLET). THE END USER PLUGS THE CHARGER DIRECTLY INTO THE WALL OUTLET IN THEIR BATHROOM. THE END USER AND THEIR HOME ARE NOT "HURT". THE END USER DID NOT SEEK MEDICAL ADVICE. THEY STOPPED USING THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590414 ↗
• MalfunctionAug 31, 2022Overheating of Device; Overheating of Device

  SF (B)(4). RE CHARGER- HOT AND MELTED. IT WAS REPORTED- HCP CALLED TECH SUPPORT AND REPORTED THAT PT'S CHARGER GOT HOT AND MELTED AT THE JUNCTION OF THE CHARGING CORD AND CHARGER. ISSUE OCCURRED ON JUNE 6TH. REPORTEDLY A NEW CHARGER HAS ALREADY BEEN SENT TO PT, BUT HCP WAS ADVISED TO CALL TO REPORT THE ISSUE. HE SAID THE CHARGER WITH THE ISSUE HAS NOT BEEN RECEIVED YET, BUT HE WILL SEND IT TO US. HCP DECLINED HARM TO PT. HE READ THE NOTES FROM ANOTHER PROVIDER THAT INDICATED THE CHARGER IS STILL FUNCTIONING, BUT DAMAGED AND OCCURRED 1 TIME. PT THINKS A POSSIBLE POWER SURGE. I ADVISED TO STOP USING THE DAMAGED CHARGER. HCP IS UNSURE IF HAS WERE IN CHARGER WHEN THE ISSUE OCCURRED. IF HAS WERE IN CHARGER WHEN THE ISSUE OCCURRED, I ADVISED TO SEND THE HAS IN FOR EVALUATION AS WELL. QE FORM EMAILED TO HCP. FLAGGED IN NAVISION. COMPLAINT CREATED. NO HARM WAS MADE TO THE USER. THIS IS A LATE CASE. THIS IS AN INITIAL REPORT. FURTHER INFORMATION WILL BE SUBMITTED AS WE GET FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327424 ↗
• MalfunctionAug 24, 2022Overheating of Device; Overheating of Device

  SF (B)(4). IT HAS BEEN REPORTED- MELTED CHARGER IN (B)(6) 2022. POWER CORD AND CHARGER MELTED TOGETHER. PT WOKE UP IN THE MORNING AND WHEN HE WENT TO GET HIS HEARING AID OUT OF THE CHARGER HE NOTICED THEY WERE NOT CHARGED AND THEN NOTICED THE CHARGER WAS HOT AND THAT THE CORD WAS MELTED IN TO IT. PATIENT WAS NOT INJURED IN ANY WAY. WAS USING CORD THAT IT CAME WITH, PLUGGED DIRECTLY IN TO WALL. (B)(6) 2022: THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING.BASED ON THE AVAILABLE INFORMATION, THE MALFUNCTION MAY LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THIS IS AN INITIAL REPORT. THIS IS A LATE CASE RECEIVED FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281412 ↗