BeltoneRecalls & reported problems across all models
Gn Hearing A/S · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 17 models of Beltone by Gn Hearing A/S in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2020 and Oct 25, 2024 — classified as 7 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (21 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 Beltone problems
Device problems
- Overheating of Device21
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Battery Problem1
- Biocompatibility1
- Detachment of Device or Device Component1
- Leak/Splash1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Skin Inflammation/ Irritation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Device Embedded In Tissue or Plaque1
- Pain1
- Skin Burning Sensation1
- Skin Irritation1
- Swelling/ Edema1
Beltone models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Beltone 20623200Hearing aid, air conduction with wireless technology7 reports
- Beltone 21625700Hearing aid, air conduction with wireless technology7 reports
- Beltone 21790400Hearing aid, air conduction with wireless technology3 reports
- Beltone 21581205Hearing aid, air conduction with wireless technology2 reports
- Beltone 19421005Hearing aid, air conduction with wireless technology1 report
- Beltone 19962900Hearing aid, air conduction with wireless technology1 report
- Beltone 20557205Hearing aid, air conduction with wireless technology1 report
- Beltone AY2ITC-D-UPHearing aid, air conduction1 report
- Beltone 20690902Hearing aid, air conduction with wireless technology1 report
- Beltone 20968075Hearing aid, air conduction with wireless technology1 report
- Beltone 21304371Hearing aid, air conduction with wireless technology1 report
- Beltone RLY2ITC-DW-MPHearing aid, air conduction with wireless technology1 report
- Beltone RLY3ITC-DW-HPHearing aid, air conduction with wireless technology1 report
- Beltone RLY3ITC-DW-MPHearing aid, air conduction with wireless technology1 report
- Beltone 21811200Hearing aid, air conduction with wireless technology1 report
- Beltone IMG6ITE-DWC-MPHearing aid, air conduction with wireless technology1 report
- Beltone 22366675Hearing Aid, Air-Conduction with Wireless Technology, Prescription1 report
Recent Beltone adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ESTIMATED DATE OF THE EVENT 01SEP2024. IT WAS REPORTED THAT THE WAX GUARD FELL OFF A HEARING AID. A GENERAL PRACTITIONER INSPECTED THE EAR AND THE WAX GUARD WAS NOT IN THERE. THE EVENT DID NOT CAUSE HARM TO THE USER. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531289 ↗MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A RECEIVER NOZZLE CAME UNGLUED. RECEIVER NOZZLE DETACHED FROM RECEIVER DURING HEARING AID MAINTENANCE. AS THE RECEIVER BROKE OUTSIDE THE EAR, NOTHING WAS STUCK IN THE EAR AND THE INCIDENT CAUSED NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20425647 ↗MalfunctionNov 8, 2023Overheating of Device; Battery Problem; Overheating of Device; Battery Problem
IN THE MORNING (8:00 - 9:00) OF 04OCT2023 IN SPAIN, THE USER LEFT HER HOME WEARING HER HEARING INSTRUMENTS. THE CHARGER WAS LEFT PLUGGED IN (BEING CHARGED). AT AROUND LUNCHTIME (13:30 - 14:00), THE PATIENT RECEIVED A PHONE CALL FROM A NEIGHBOR BECAUSE THERE WAS SMOKE COMING OUT OF HER HOME. THE POLICE AND FIREFIGHTERS WERE ALSO CALLED. THE FIREFIGHTERS CUT OFF THE ELECTRICITY SUPPLY, IDENTIFIED THE ROOT CASE AND VENTILATED THE HOUSE. THE CHARGER WAS FOUND PLUGGED IN AND BURNING. THE INCIDENT DID NOT CAUSE ANY PATIENT HARM, HOWEVER THE STAND ON WHICH THE CHARGER WAS PLACED WAS DAMAGED ON 08DEC2023, NO FURTHER FOLLOW UP RECEIVED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091540 ↗MalfunctionAug 21, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED THAT THE CHARGER ALLEGEDLY FRIED/BURNED AT THE CHARGING PORT. THERE WAS NO HARM TO THE USER, AND NO REPORTED PROPERTY DAMAGE. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17583941 ↗MalfunctionAug 1, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT (B)(6) 2023: IT WAS REPORTED THAT THE CHARGER EXPLODED AND MELTED AT CHARGER CONNECTION WHILE PLUGGED INTO A CAMPER OUTLET. ORIGINAL ACCESSORIES WERE USED. NO HARM TO THE USER OR PROPERTY HAS BEEN REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434535 ↗InjuryJul 28, 2023Biocompatibility; Biocompatibility
DATE OF INCIDENT (B)(6) 2023. (B)(6) 2023 IT WAS REPORTED: A USER HAD A POTENTIAL REACTION TO A SMALL CLOSE DOME USED WITH A RELY 3/63 AND MP RECEIVER. USER HAS SYMPTOMS OF REDNESS AND IRRITATION IN THE EAR CANAL. USER HAS BEEN IN CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER (MD) WHOM SAID DOME WAS IMPROPERLY FITTED AND PRESCRIBED STEROIDS. NO FURTHER INFORMATION EXPECTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17412286 ↗MalfunctionJul 17, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE (B)(6) 2023. (B)(6) 2023, IT HAS BEEN REPORTED- CHARGER CAUGHT ON FIRE. FURTHER INFORMATION IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17331884 ↗MalfunctionJul 13, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT 01-APR-2023. IT IS REPORTED THAT THE CHARGER MELTED AT USB PORT. THERE WAS NO HARM TO THE USER. NO PROPERTY DAMAGE REPORTED. AWARENESS DATE: 14JUN2023. FURTHER FOLLOW UP IS EXPECTED. 10AUG2023 NO FURTHER FOLLOW UP RECEIVED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314724 ↗MalfunctionJun 28, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT SOMETIME IN (B)(6)2023 (BEST ESTIMATE) ON (B)(6)2023 IT WAS REPORTED THAT CHARGER AND CABLE MELTED AND WAS RETURNED FOR REPAIR. IT IS UNSURE IF SUPPLIED MICRO USB CABLE AND WALL SOCKET WERE USED. NO HARM TO PEOPLE OR PROPERTY. DEVICE IS OUT OF WARENTY NO FURTHER FOLLOW UP EXPECTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221340 ↗InjuryJun 21, 2023Overheating of Device; Overheating of Device
ON (B)(6) 2023 (BEST ESTIMATE) IT WAS ALLEGED THAT PATIENT'S RIGHT HEARING AID WAS "BURNING HOT" AFTER A NIGHT IN THE CHARGER. PATIENT DROPPED THEM BECAUSE IT WAS SO "SO HOT THAT HE BURNED HIMSELF ON IT". FOLLOW UP INFORMATION RECEIVED : "THERE WAS A LITTLE BIT OF RED ON ONE FINGER, BUT IT WASN'T MUCH. PHOTO IS PROBABLY NO LONGER POSSIBLE AS IT IS GONE NOW. BUT IT WASN'T THAT BAD".
Patient problems: Skin Burning Sensation
MAUDE report 17171802 ↗MalfunctionMay 16, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED- ACHIEVE CHARGER MELTED CHARGER WAS BROUGHT ON (B)(6) 2023. NO HARM DONE TO THE PATIENT OR PROPERTY. ORIGINAL EQUIPMENT WAS USED. RECOMMENDATION FROM THE HCP: USE CHARGER AS PER THE INSTRUCTIONS. DO NOT USE ANY OTHER USB CABLES OR PLUGS OTHER THAN WHAT CAME WITH THE CHARGER (MORE OF A REMINDER SINCE THE INCIDENT DID NOT INVOLVE ANY AFTER MARKET PARTS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16937914 ↗MalfunctionMay 12, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED: CHARGER CORD MELTED WHERE IT PLUGS INTO THE CHARGER ITSELF. USER NOTICED IT UNPLUG IT AND BROUGHT IT INTO THE PROVIDER'S OFFICE. ORIGINAL ACCESSORIES HAVE BEEN USED. BOTH HEARING AIDS WERE IN THE CHARGER WHEN THE INCIDENT HAPPENED. NO HARM TO THE PATIENT OR TO THEIR HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16917803 ↗MalfunctionApr 19, 2023Overheating of Device; Overheating of Device
IT IS REPORTED THAT: ESTIMATED DATE OF INCIDENT (B)(6) 2023. FOR A HEARING AID CHARGER CAUGHT ON FIRE WHERE CORD PLUGS INTO CHARGER. NO HARM DONE TO THE PATIENT OR TO THEIR HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767068 ↗MalfunctionApr 19, 2023Leak/Splash; Leak/Splash
18-APR-2023: IT WAS REPORTED: "UNSURE IF THE BATTERY ACID HAS CAUSED ANY INTERNAL CIRCUIT DAMAGE". USER DIDN'T PUT AID ON AS NOTICED SOMETHING WAS LEAKING. NO HARM TO USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766918 ↗InjuryApr 19, 2023Product Quality Problem; Product Quality Problem
(B)(6) 2023: IT HAS BEEN REPORTED THAT WAX FILTERS IN THE HEARING AID HAVE FALLEN OFF IN USER'S EARS. THE USER HAD TO GO TO HOSPITAL TO GET THEM REMOVED. THE WHITE RING CASING THAT HOUSES THE WAX FILTER LOOKS TO BE CRACKED. THE WAX FILTERS DO NOT SIT NEATLY, THEY PROTRUDE MORE THAN NORMAL AND DON'T SIT SYMMETRICALLY FLAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766826 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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