GN ReSoundRecalls & reported problems across all models
Gn Hearing A/S · 106 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 206
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls
- 0
We found 106 models of GN ReSound by Gn Hearing A/S in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between May 29, 2017 and Sep 24, 2026 — classified as 56 injuries, 150 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (100 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GN ReSound problems
Device problems
- Overheating of Device100
- Patient Device Interaction Problem31
- Patient-Device Incompatibility13
- Detachment of Device or Device Component12
- Adverse Event Without Identified Device or Use Problem10
- Fracture8
- Insufficient Device Problem Information5
- Biocompatibility4
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- Skin Irritation24
- Partial Hearing Loss16
- Skin Inflammation/ Irritation10
- Hypersensitivity/Allergic reaction8
- Hearing Impairment7
- Local Reaction6
- Ear infection5
GN ReSound models
106 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- GN ReSound 20472100Hearing aid, air conduction with wireless technology55 reports
- GN ReSound 21625000Hearing aid, air conduction with wireless technology20 reports
- GN ReSound 20928601Hearing aid, air conduction with wireless technology4 reports
- GN ReSound KE3ITC-DW-MPHearing aid, air conduction with wireless technology4 reports
- GN ReSound 21790300Hearing aid, air conduction with wireless technology4 reports
- GN ReSound 21569800Hearing aid, air conduction with wireless technology3 reports
- GN ReSound 21763000Hearing aid, air conduction with wireless technology3 reports
- GN ReSound 21900500Hearing aid, air conduction with wireless technology3 reports
- GN ReSound 20574204Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20413909Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20686202Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20686205Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20686301Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20686320Hearing aid, air conduction with wireless technology2 reports
- GN ReSound 20928608Hearing aid, air conduction with wireless technology2 reports
- GN ReSound RE9CIC-W-MPHearing aid, air conduction with wireless technology2 reports
- GN ReSound RE9ITC-DWT-UPHearing aid, air conduction with wireless technology2 reports
- GN ReSound PZ8ITE-DW-UPHearing aid, air conduction with wireless technology2 reports
- GN ReSound 21303875Hearing aid, air conduction with wireless technology2 reports
- GN ReSound RU5ITC-DWC-MPHearing Aid, Air-Conduction with Wireless Technology, Prescription2 reports
- GN ReSound 18741402Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19368209Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19397402Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19420902Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19420808Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19861108Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19706501Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19706502Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19706702Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19706708Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19706902Hearing aid, air conduction with wireless technology1 report
- GN ReSound 19707002Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20357810Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20556905Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20585408Hearing aid, air conduction with wireless technology1 report
- GN ReSound FT8ITC-DW-UPHearing aid, air conduction with wireless technology1 report
- GN ReSound 20574215Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20661402Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20661405Hearing aid, air conduction with wireless technology1 report
- GN ReSound EY2ITC-D-HPHearing aid, air conduction1 report
- GN ReSound EY3ITE-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound LT5ITE-DW-UPHearing aid, air conduction with wireless technology1 report
- GN ReSound LT7ITE-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound LT9ITC-DW-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound LT9ITE-DW-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound 20413905Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20686204Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20686220Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20967272Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20967277Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20967372Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20959905Hearing aid, air conduction with wireless technology1 report
- GN ReSound RE5ITC-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound RE5ITC-DW-UPHearing aid, air conduction with wireless technology1 report
- GN ReSound RE9ITE-DW-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound RE9MIH-W-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound RE9MIH-W-UPHearing aid, air conduction with wireless technology1 report
- GN ReSound 21227300Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21227500Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21165020Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21197320Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21211609Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21263705Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21435508Hearing aid, air conduction with wireless technology1 report
- GN ReSound PZ8ITC-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound PZ8ITE-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound 21339774Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21508700Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20419970Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20419974Hearing aid, air conduction with wireless technology1 report
- GN ReSound 20419976Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21303872Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21303874Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21230851Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21539700Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21587700Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21588900Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21593800Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21495902Hearing aid, air conduction with wireless technology1 report
- GN ReSound KE2ITC-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound KE3CIC-W-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound KE3ITC-DW-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound KE3ITE-DW-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound KE3ITE-DW-UPHearing aid, air conduction with wireless technology1 report
- GN ReSound 21630605Hearing aid, air conduction with wireless technology1 report
- GN ReSound 21810900Hearing aid, air conduction with wireless technology1 report
- GN ReSound RT9ITC-DWC-HPHearing aid, air conduction with wireless technology1 report
- GN ReSound RT9ITE-DWC-MPHearing aid, air conduction with wireless technology1 report
- GN ReSound 21973300Hearing aid, air conduction with wireless technology1 report
- GN ReSound RT5CIC-MPHearing aid, air conduction1 report
- GN ReSound 22175673Hearing aid, air conduction with wireless technology1 report
- GN ReSound 22176574Hearing aid, air conduction with wireless technology1 report
- GN ReSound 22345400Hearing aid, air conduction with wireless technology1 report
- GN ReSound 22357500Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound 22364776Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound 22364777Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound 22366472Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound 22485272Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound RU9ITC-DWC-HPHearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
- GN ReSound RU9ITE-DWC-MPHearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
Recent GN ReSound adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Insufficient Device Problem Information
Estimated date of incident (b)(6) 2026.It was reported that when the user hears any loud noise, it sounds like a gun firing rapidly. A weekend it happened in the user's wood shop, and he cut his hand.Further follow up is expected.
Patient problems: Laceration(s)
MAUDE report 50880994 ↗InjuryAug 12, 2026Patient Device Interaction Problem
It is reported that on the (b)(6) 2026, an in-the-ear (ITE) device had entered the user's ear canal deeper than usual, although he was still able to remove it himself. However, the following day, the same event occurred, and the user was unable to remove the device on his own, requiring a visit to the hospital.The device was successfully removed at the hospital.No further follow up is available.
Patient problems: Foreign Body In Patient
MAUDE report 50223148 ↗MalfunctionAug 7, 2026Overheating of Device
Patient problems: Skin Burning Sensation
MAUDE report 50171198 ↗InjuryJun 3, 2026Battery Problem
IT WAS REPORTED THAT A USER EXPERIENCED A CHEMICAL BURN ON THE BACK OF HIS RIGHT EAR, AFTER A HEARING AID BATTERY LEAKED. THE USER WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING THE BURN. IT IS UNKNOWN WHETHER ANY MEDICAL INTERVENTION WAS PRESCRIBED. DESPITE ATTEMPTS IT HAS NOT BE POSSIBLE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. NO FURTHER FOLLOW UP IS NOT AVAILABLE OR EXPECTED.
Patient problems: Caustic/Chemical Burns
MAUDE report 25374122 ↗InjuryMar 6, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE HEARING AID FELT WARM AND WAS BURNING THE USER'S EAR. USER TOOK IT OFF AND CAME INTO THE AUDIOLOGISTS' OFFICE. THE AUDIOLOGIST TOOK A PICTURE OF THE EAR, WHICH SHOWS A SORE BEING PRESENT BEHIND THE RIGHT EAR. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Burn(s)
MAUDE report 24529814 ↗InjuryFeb 10, 2026Patient Device Interaction Problem
IT IS REPORTED THAT USER EXPERIENCED ITCHING IN THE EAR CANAL FOR BOTH EARS, WATERY EYES AND A SUFFOCATING FEELING IN THE THROAT. THE SKIN REACTION HAS BEEN CONFIRMED BY DOCTOR BUT IT IS UNKNOWN IF ANY MEDICATION HAS BEEN PRESCRIBED. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24304108 ↗MalfunctionJun 27, 2025Fracture; Fracture
IT WAS REPORTED THAT A HEARING AID BROKE INSIDE THE USER'S EAR. THE FACEPLATE CAME OFF OF THE HEARING AID, AND SUBSEQUENT ATTEMPTS TO REMOVE THE REST OF THE DEVICE CAUSED DAMAGE TO THE SHELL AND THE EAR CANAL. THE DEVICE WAS REMOVED BY THE WIFE OF THE USER. USER DID NOT SEEK MEDICAL ATTENTION FOLLOWING THE INCIDENT. FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Laceration(s)
MAUDE report 22343830 ↗MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DATE OF INCIDENT: 14APR2025 IT HAS BEEN REPORTED THAT TWO WAX FILTERS WERE DISCOVERED BY A HEARING CARE PROFESSIONAL (HCP) IN THE USER'S EAR CANAL, FOLLOWING THE USE OF CUSTOM IN-THE-EAR HEARING AIDS. HCP ADVISED THE USER TO GO TO A PHYSICIAN TO HAVE THE WAX FILTERS REMOVED. THE USER REFUSED AND WANTED TO REMOVE THEM HIMSELF. THE USER WAS STRONGLY ADVISED AGAINST REMOVED THE FILTERS HIMSELF AND ADVISED TO HAVE A PROFESSIONAL TO REMOVE THE FILTERS. THE USER COULD NOT FEEL THE FILTERS IN THE EAR CANAL, AND THE HCP ALLOWED THE USER TO LEAVE THE CLINIC WITH THEM STILL IN HIS EARS. IT IS UNKNOWN IF THE USER SOUGHT MEDICAL ASSISTANCE TO HAVE THE FILTERS REMOVED. IT HAS BEEN REPORTED THAT THE DETACHED WAX FILTERS HAVE NOT CAUSED HARM TO THE USER. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22033895 ↗InjuryDec 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ESTIMATED DATE OF THE EVENT 01 OCT 2024. IT WAS REPORTED THAT THE USER EXPERIENCED ITCHINESS AND CLEAR FLUID ABOUT A MONTH INTO WEARING HEARING AID. A NURSE PRACTITIONER RECOMMENDED CORTISPORIN EAR DROPS. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Ear infection
MAUDE report 20900424 ↗MalfunctionDec 6, 2024Melted; Melted
DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED THAT THE HEARING AIDS WERE CHARGING AND WHEN THEY CHECKED THEY WERE BURNT OUT. NO HARM TO THE USER, OTHERS OR PROPERTY REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20862110 ↗MalfunctionNov 14, 2024Break; Break
ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT THE WAX FILTER OF A HEARING AID BROKE. NO HARM TO THE USER WAS REPORTED. FURTHER FOLLOW UP IS EXPECTED. 09DEC2024: NO FURTHER FOLLOW UP IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681693 ↗MalfunctionOct 31, 2024Use of Device Problem; Use of Device Problem
MANUFACTURER'S REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT THE WAX BUSTER FELL OFF A HEARING AID WHILE THE USER WAS WIPING IT OVER TO CLEAN. THE OBJECT DID NOT REQUIRE REMOVAL AND THE EVENT HAS NOT CAUSED HARM. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577300 ↗MalfunctionOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WAX FILTER WAS PULLED OFF AN IN THE EAR HEARING AID. IT WAS THE STAFF AT THE CLINIC THAT PULLED IT OFF. NOTHING WAS LOST IN THE EAR OF THE USER. SUBSEQUENTLY, NO HARM RESULTED FROM THE EVENT. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478470 ↗InjuryOct 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ON AN UNKNOWN TIME BETWEEN (B)(6) 2024 USER DEVELOPED AN EAR INFECTION AND WAS PRESCRIBED ANTIBIOTICS(OTOFLOXACIN). IT IS UNKNOWN IF THE EAR INFECTION WAS IN THE EAR CANAL OR IN THE MIDDLE EAR. THE USER HAS BEEN WEARING THE SINCE 2019 AND REPORTS HAVING ITCHY AND SCALY SKIN CONSISTENTLY OVER THE YEARS. HEARING CARE PROVIDER SAW THE USER IN APRIL AND NOTICED SCALY SKIN IN BOTH EARS AND WHAT LOOKED LIKE AN INFECTION IN THE RIGHT EAR. HCP SUGGESTED USER TO GO TO GENERAL PRACTITIONER. ON AN UNKNOWN TIME, THE USER WENT TO THE ENT AND WAS DIAGNOSED WITH EAR INFECTION. THERE IS NO HISTORY OF ALLERGIES, HYPERSENSITIVITY OR FUNGAL INFECTIONS FOR THE USER.
Patient problems: Ear infection
MAUDE report 20367647 ↗MalfunctionSep 27, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
ESTIMATED DATE OF THE EVENT 01AUG2024. IT HAS BEEN REPORTED THAT THE THE USER DROPPED HEARING AIDS OFF A FEW DAYS AGO BECAUSE THE GROMMETS WERE COMING OUT OF THE EARMOLDS ALREADY, AND HE HAS BEEN UNABLE TO CLEAN OR CHANGE THE WAX FILTERS BECAUSE THE GROMMETS WON'T HOLD ANYTHING. NO OBJECT WAS STUCK IN THE EAR, NO HARM OR INJURY REPORTED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320088 ↗
Other Gn Hearing A/S products
All Gn Hearing A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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