GN Hearing 21655200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05708296213375), received between Jan 11, 2024 and Jul 29, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Detachment of Device or Device Component

  It was reported that a wax filter grommet fell out of an encased receiver. The grommet fell out while the end-user was handling the device, it is unknown what the user was doing with the device at the time of the event. The wax filter grommet fell off outside of the user's ear, and hence no harm resulted from the event. No further follow up is expected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068614 ↗
• MalfunctionJun 26, 2026Material Disintegration

  IT HAS BEEN REPORTED THAT A HEARING AID USER HAD MATERIAL PEELING ON AN ENCASED EARMOLD AFTER 2 WEEKS OF USE. THE USER REPORTED THAT SHE WAKES UP IN THE MORNING FEELING LIKE SHE HAS DEBRIS IN HER EAR. IT HAS NOT BEEN CONFIRMED WHETHER THE USER DOES HAVE MATERIAL FROM THE SHELL IN HER EAR, AND SHE HAS NOT SOUGHT MEDICAL ATTENTION. THE USER STOPPED WEARING THE EARMOULD AND A REMAKE WAS ORDERED. IT WAS REPORTED THAT THERE WAS NO HARM TO THE USER. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633454 ↗
• MalfunctionFeb 25, 2026Fracture

  ESTIMATED DATE OF INCIDENT (B)(6) 2026. IT WAS REPORTED THAT THE SHELL OF A RECEIVER-IN-EAR EARMOULD BROKE INSIDE IN THE USER'S EAR, AND A PIECE WAS STUCK IN THE CANAL. THE USER WAS INSTRUCTED BY THE PROVIDER TO SEE A MEDICAL DOCTOR/EAR-NOSE-THROAT DOCTOR, AFTER THE PROVIDER COULD NOT REMOVE IT. NO HARM HAS BEEN REPORTED FOLLOWING THE INCIDENT. FURTHER FOLLOW UP IS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441596 ↗
• InjuryOct 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ESTIMATED DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED THAT THE USER WAS FIT WITH HEARING AID IN (B)(6) AT FOLLOW UP APPOINTMENT (B)(6) 2024 SHE REPORTED THAT SHE HAD NOT BEEN ABLE TO WEAR DEVICES DUE TO DISCOMFORT, PAIN AND SUSPECTED THERE MAY BE AN INFECTION AS SHE GOT FLUID FROM THE EAR. THE USER WENT TO SEE HER GENERAL PRACTITIONER WHO SUSPECTED EXTERMAL EAR INFECTION AND PRESCRIBED BROAD SPECTRUM DROPS THAT WOULD ADRESS BACTERIAL AND FUNGAL. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: Infectious Otitis Externa

  MAUDE report 20479762 ↗
• MalfunctionOct 11, 2024Fracture; Fracture

  ESTIMATED DATE OF THE EVENT: 11SEP2024. IT WAS REPORTED THAT AN NCASED EARMOLD BROKE. NO HARM TO THE USER WAS REPORTED. FURTHER FOLLOW UP IS EXPECTED. 06NOV2024: NO FURTHER FOLLOW UP INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425646 ↗
• MalfunctionSep 20, 2024Fracture; Fracture

  ESTIMATED DATE OF INCIDENT (B)(6)2024 IT WAS REPORTED THAT AN NCASED EARMOULD HAS CRACKED. NO OBJECT REQUIRED REMOVAL, AND USER STOPPED USING THE DEVICE AFTER NOTICING THE CRACK, WHEN HE SAID HE DIDN'T HEAR AS WELL FOR A FEW DAYS. THERE WAS NO HARM TO THE USER FOLLOWING THE INCIDENT. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264795 ↗
• MalfunctionMay 8, 2024Fracture; Fracture

  ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT THE EARMOULD BROKE. THERE IS NO REPORT OF ANY HARM TO THE USER. NO FURTHER INFORMATION IS AVAILABLE, OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266112 ↗
• InjuryJan 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  DATE OF INCIDENT: (B)(6) 2023 IT WAS REPORTED THAT THE USER EXPERIENCES PAIN AND SWELLING ON ONE SIDE, IN THE EXTERNAL EAR CANAL. SYMOTOMS REPORTED WERE RED, SWOLLEN, PAINFUL. REPORTED THAT WITH REMOVAL OF THE DEVICE IMPROVED ISSUE. BUT ALSO REPORTED THAT THE ISSUE STARTED AFTER A BOUT OF LARYNGITIS. FIT WITH EARMOLD ON (B)(6) 2023 SYMPTOMS WITH THE EAR BEGAN ON SATURDAY ON (B)(6) 2023 REPORTED LARYNGITIS ONSET ON (B)(6) 2023 USER IS REPORTABLY ALLERGIC TO SURGICAL GLUE. THE USER WAS SEEN IN URGENT CARE TO ADDRESS CONCERNS WITH THE EAR, AND WAS PRESCRIBED AMOXICILLIN A 10-DAY COURSE 2/DAY AM AND PM. NO FURTHER FOLLOW UP HAS BEEN RECEIVED AND IS EXPECTED.

  Patient problems: Ear Pain; Ear infection; Unspecified Ear or Labyrinth Problem

  MAUDE report 18491010 ↗