GN ReSound 21625000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05708296200061), received between Aug 25, 2022 and Aug 22, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (20 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

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

  ESTIMATED DATE OF INCIDENT (B)(4) 2023. (B)(4) 2023, IT WAS REPORTED: CHARGER MELTED. THE INSTRUMENTS WORKED PERFECTLY PRIOR TO THE OVERHEATING INCIDENT THIS PAST WEEKEND. THE PATIENT REALIZED SHE SMELLED SOMETHING ELECTRICAL/HOT. SHE THOUGHT IT WAS THE CURLING IRON IN THE ADJACENT ROOM AS IT WAS USED THAT MORNING. THEN, LATER IN THE DAY, SHE REALIZED HER HA'S WEREN'T WORKING CORRECTLY. SHE ATTEMPTED CHARGING BUT THEY WOULDN'T CHARGE UP. SO SHE CALLED RIGHT AWAY. HEALTH CARE PROVIDER (HCP) LOOKED AT THE CHARGER. HCP PLUGGED IT IN AND IMMEDIATELY REALIZED IT WAS SMELLING ELECTRICAL. HCP THEN INSPECTED FURTHER AND DISCOVERED THAT THE CORD HAD LITERALLY MELTED INTO THE PORT. ORIGINAL GN ACCESSORIES WERE USED. DEVICE IS COVERED BY WARRANTY UNTIL NOVEMBER 2023 NO FURTHER FOLLOW UP EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596231 ↗
• MalfunctionAug 10, 2023Overheating of Device; Overheating of Device

  ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED THAT THE CHARGER PORT CAUGHT ON FIRE AND MELTED AT THE BACK OF THE CHARGER. INVESTIGATION OF THE CHARGER SHOWS NO SIGNS OF FIRE. THERE WAS NO HARM TO THE USER, AND NO REPORT OF PROPERTY DAMAGE. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498426 ↗
• MalfunctionJul 21, 2023Overheating of Device; Overheating of Device

  ESTIMATED DATE OF INCIDENT (B)(6) 2023. (B)(6) 2023 IT WAS REPORTED: CHARGER IS HOT TO THE TOUCH AND REMAINING WARM AFTER SITTING ALONE. IMAGES OBTAINED OF THE DEVICE SHOWED A MELTED CHARGER PORT. FURTHER FOLLOW UP IS EXPECTED. 17AUG2023 NO FURTHER FOLLOW UP HAS BEEN RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369468 ↗
• MalfunctionJun 21, 2023Overheating of Device; Overheating of Device

  (B)(6)2023, IT WAS REPORTED THAT THE CHARGER CORD IS PULLING OUT, AND SMELLS LIKE FIRE. HEARING CARE PROVIDER STATED THAT INCIDENT HAD CAUSED ANY HARM. ORIGINAL ACCESSORIES WERE NOT USED. FURTHER FOLLOW UP INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169016 ↗
• MalfunctionMay 31, 2023Overheating of Device; Overheating of Device

  ON (B)(6) 2023: ON AN UNKNOWN DATE ((B)(6) 2023 BEST ESTIMATE) CHARGER PORT MELTED. ORIGINAL EQUIPMENT USED. NO PERSONAL OR PROPERTY HARM REPORTED. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029558 ↗
• MalfunctionMay 24, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED ON (B)(6)2023: THE CHARGER WIRE AND CHARGER STARTED MELTING AND SMOKING WHEN THE PATIENT PLUGGED IT IN. THE CHARGER IS RUINED. NO PERSONAL HARM OR PROPERTY DAMAGE. ORIGINAL EQUIPMENT WAS USED. THE DEVICE IS COVERED BY THE WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990600 ↗
• MalfunctionMay 10, 2023Overheating of Device; Overheating of Device

  10-MAY-2023: ON AN UNKNOWN DATE ((B)(6) 2023 BEST ESTIMATE) BACK OF THE CHARGER BURNED. CHARGER WAS PULLED INTO THE WALL AND THE PART WHERE THE CORD PLUGS INTO THE CHARGER IS WHERE IT WAS BURNED NO PATIENT HARM OR PROPERTY DAMAGE REPORTED. UNKNOWN IF ORIGINAL EQUIPMENT WAS USED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901479 ↗
• MalfunctionApr 27, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT: CHARGER WAS PLUGGED INTO WALL AND THE CORD MELTED AT THE POINT OF THE BOX AND CORD. ORIGINAL ACCESSORIES WAS USED. NO HARM TO PEOPLE OR PROPERTY. THE HEARING AID WAS BOUGHT ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822654 ↗
• MalfunctionFeb 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 BEST ESTIMATE THE CHARGER CAUGHT ON FIRE IN THE MIDDLE OF THE NIGHT. THE CHARGER WAS ON NIGHTSTAND. NO HARM TO THE PATIENT OR PROPERTY REPORTED. NO CONTACT WITH MEDICAL PRACTITIONER REPORTED. ONLY ORIGINAL EQUIPMENT WAS USED. CLINIC HAS REPLACED THE CHARGER. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291660 ↗
• MalfunctionFeb 2, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT WAS REMOVING HEARING AIDS OUT OF THE CHARGER AND NOTICED THEY WERE WARM. THE PATIENT THEN NOTCIED THAT THE CHARGER WAS MELTED WHERE CABLE PLUGS IN TO THE CHARGER. THE HEARING AIDS WERE FUNCTIONING AS USUAL. ONLY ORIGINAL EQUIPMENT WAS USED. HEARING CARE PROVIDER ADVISED TO DELIVER BOTH THE CHARGER AND THE HEARING AIDS TO THE CLINIC. NO HARM TO THE PATIENT AND NO CONTACT WITH MEDICAL PRACTITIONER REPORTED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282044 ↗
• MalfunctionJan 20, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE (DEC-2022 IS A BEST ESTIMATE) CHARGER GOT HOT AND THEN SMOKING AND THEN BURNT OUT AT THE PORT OF THE CABLE ENTRY. FOLLOW UP INFORMATION RECEIVED. THE PATIENT PLUGGED IN THE CHARGER AND SAW SMOKE THEN NOTICED IT WAS BURNED AT THE PORT OF ENTRY FOR THE CORD. ORIGINAL EQUIPMENT WAS USED. NO HARM TO THE PATIENT OR PROPERTY REPORTED. THE DEVICE WAS REPLACED WITH A NEW ONE. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16212930 ↗
• MalfunctionJan 19, 2023Overheating of Device; Overheating of Device

  18-JAN-2023: IT WAS REPORTED THAT ON UNKNOWN DATE (DECEMBER 2022 IS A BEST ESTIMATE) CHARGER BURNED IN THE BACK WHERE IT PLUGS IN. FOLLOW UP INFORMATION RECEIVED ON 30-DEC-2022. THE CHARGER WAS PLUGGED IN AND MELTED THE CORD. THE HEARING AIDS WHERE IN THE CHARGER WHEN THE EVENT TOOK PLACE. THE PATIENT CONFIRMS THAT THE HEARING AIDS WORK FINE. ORIGINAL EQUIPMENT WAS USED. NO HARM TO THE PATIENT OR PROPERTY REPORTED. HEARING CARE PROVIDER ADVISED THE PATIENT NOT TO USE THE DAMAGED CHARGER AND HAS SENT A REPLACEMENT DEVICE. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16201365 ↗
• MalfunctionDec 8, 2022Overheating of Device; Overheating of Device

  ON 07-DEC-2022: ON UNKNOWN DATE (BEST ESTIMATE: (B)(6) 2022) CHARGING UNIT MELTED IN THE BACK. THE CHARGER HAD BURN MARKS AND THE PLASTIC WAS MELTED. NO HARM WAS DONE TO THE PATIENT AND NO VISIT TO A DOCTOR. AWAITING FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938340 ↗
• MalfunctionNov 17, 2022Overheating of Device; Overheating of Device

  16NOV2022: IT WAS REPORTED THAT HEARING AID CHARGER SHORTED OUT AND MELTED ((B)(6) 2022 IS A BEST ESTIMATE). NO HARM TO THE PATIENT AND/OR MEDICAL INTERVENTION REPORTED. THE INCIDENT HAPPENED ON A UNKNOWN DATE. DATE IN B3 IS BEST ESTIMATE. THE PATIENT HAS AGREED TO SEND IN THE CHARGER AND ATTACH NOTES WITH FOLLOW UP INFORMATION. THE REPLACE ORDER WITH A NEW CHARGER HAS BEEN SENT TO THE PATIENT ON (B)(6) 2022. CHARGER WITH THE NOTES HAS NOT BEEN RECEIVED YET. 15DEC2022: MANUFACTURER RECEIVED THE DEVICE, BUT NO NOTES ATTACHED. IT IS NOT POSSIBLE TO LOCATE THE NOTES ANYWHERE, THEREFORE NO FOLLOW UP INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814258 ↗
• MalfunctionOct 28, 2022Overheating of Device; Overheating of Device

  (B)(6): ON AN UNKNOWN DATE CHARGER CAUGHT ON FIRE. THE HCP INFORMED THAT PATIENT HAD NO INJURIES. PATIENT HAD WRONG PLUG ADAPTOR ATTACHED WHEN BROUGHT CHARGER IN, BUT CLAIMED IT WAS PLUGGED IN TO CORRECT ADAPTOR WHEN THE FIRE STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15689988 ↗
• MalfunctionOct 6, 2022Overheating of Device; Overheating of Device

  ON 06SEP2022: IT WAS REPORTED THAT THE PATIENT USED DIFFERENT WALL PLUG AND IT FRIED THE CORD AND CHARGER. ON 03NOV2022: THREE 'GOOD FAITH EFFORTS' WERE MADE TO RECIEVE FOLLOW UP INFORMATION. NO INFORMATION WAS RECIEVED. NO FURTHER FOLLOW UP INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549021 ↗
• MalfunctionSep 29, 2022Overheating of Device; Overheating of Device

  IT HAS BEEN REPORTED THE HEARING AIDS GOT HOT THEN BROUGHT IN THE MELTED CHARGER. IT DID MELT SOMEWHAT BUT DID NOT BURST INTO FLAMES. IT IS BELIEVED THE CHARGER WAS PLUGGED INTO A POWER STRIP. HEARING AIDS WERE SENT IN DUE TO GETTING HOT. THE USER WAS NOT HURT. HEARING AID REPLACED. NO MORE INFORMATION CAN BE PROVIDED. 28-OCT-2022: EVENT OCCURRED ON AN UNKNOWN DATE, ESTIMATED TO OCCURRED IN AUGUST 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507677 ↗
• MalfunctionSep 23, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HEARING AID CHARGER PORT BURNED. NO HARM TO THE PATIENT REPORTED AND NO CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER. THE MALFUNCTION WAS ACTUALLY DISCOVERED IN THE OFFICE OF THE HEAR CARE PROFESSIONAL. THEIR BELIEF IS THAT IT WAS A FAULTY OUTLET AT THE PATIENT'S OFFICE. DEVICE WAS INVESTIGATED AT THE HCP OFFICE, AND HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475177 ↗
• MalfunctionSep 1, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS HEARING AID CHARGER HAS MELTED AROUND THE PLUG-IN AREA. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15333376 ↗
• MalfunctionAug 25, 2022Overheating of Device; Overheating of Device

  A COMPLAINT WAS FILED ON (B)(6) 2022 ABOUT HA CHARGER CORD, THAT STARTED TO MELT WHILE PLUGGED IN CUSTOMERS HOUSE. THE CUSTOMER COULD SMELL BURNING PLASTIC, AND UNPLUGGED THE DEVICE. ONLY THE ORIGINAL EQUIPMENT WAS INVOLVED IN THE INCIDENT. NO HARM TO THE CUSTOMER REPORTED AND THE CUSTOMER WAS NOT IN CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292816 ↗