GN Hearing 21655000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708296213351), received between Feb 2, 2023 and May 8, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ESTIMATED DATE OF INCIDENT ON (B)(6) 2025. IT HAS BEEN REPORTED THAT A WAX GUARD GROMMET HAS COME LOOSE AFTER REPAIR. THE WAX GUARD GROMMET FALLS OUT OF THE INCASED EARMOLD. THERE IS NO REPORTED 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 21984473 ↗
• MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DATE OF INCIDENT AROUND 18-OCT-2024. IT HAS BEEN REPORTED THAT THE WAX GUARD DOES NOT STAY IN PLACE IN AN ENCASED MOLD. HEARING CARE PROVIDER CHECKED THE USER'S EAR AND THERE WAS NO OBJECT IN EAR. THERE HAS BEEN NO HARM REPORTED IN THE CASE. THE USER HAS NOT BEEN IN CONTACT WITH AN AUTHORIZED MEDICAL PROFESSIONAL. NO FURTHER FOLLOW UP IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692779 ↗
• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DATE OF EVENT 10JUN2024. IT HAS BEEN REPORTED THAT THE BRASS RING ON THE EARMOULD, WHICH HOLDS THE WAX FILTER, HAS FALLEN OUT. IT HAPPENED WHEN THE HEARING CARE PROVIDER WAS CHANGING THE WAX FILTER, THE BRASS RING CAME OUT WITH THE FILTER, WHILE IN THE HAND OF THE HEARING CARE PROVIDER. THE EVENT HAS NOT CAUSED ANY HARM. FURTHER FOLLOW UP IS EXPECTED. 09-AUG-2024: NO FOLLOW UP RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19717894 ↗
• MalfunctionJun 17, 2024Product Quality Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Product Quality Problem; Detachment of Device or Device Component; No Apparent Adverse Event

  ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT THE BRASS RING THAT HOLDS THE CERUSTOP WAX FILTER FELL OUT OF THE MOULD. NOTHING ENDED UP IN THE PATIENT'S EAR CANAL. THERE WAS NO HARM TO THE USER FOLLOWING THIS INCIDENT. FURTHER FOLLOW UP IS EXPECTED. (B)(6) 2024 INVESTIGATION OF THE DEVICE SHOWED NO DEFECTS. THE EARMOULD WAS RECEIVED BY THE MANUFACTURER, INSPECTION OF THE DEVICE SHOWED THAT THE BRASS RING IS SECURELY ATTACHED TO THE MOULD AND CANNOT BE REMOVED EVEN WITH A SET OF TWEESERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547195 ↗
• MalfunctionFeb 2, 2023Mechanical Problem; Mechanical Problem

  ON 01-FEB-2023: ON (B)(6) 2023 PATIENT'S MOTHER NOTICED THE GOLD RING HAD FALLEN OFF OF EARMOLD AGAIN AND LOOKED INTO PATIENT'S EAR AND COULD SEE A WAX FILTER AND IMMEDIATELY TOOK HIM (HE IS A 16 YR OLD PEDIATRIC PATIENT) TO (B)(6) (URGENT CARE) TO HAVE HIS EAR FLUSHED. THERE WERE 3 WAX FILTERS IN HIS EAR. HE DOES NOT HAVE AN EAR INFECTION OR ANY FURTHER ISSUES, SEEMINGLY. NO HARM WAS CAUSED. IT WAS ALSO REPORTED THAT THE PATIENT'S MOM CONTACTED THE HEARING CARE PROVIDER (HCP) THAT HER SON'S EAR SEEMED IRRITATED AND SMELLED, THE HCP SUGGESTED THAT SHE GO IMMEDIATELY TO AN URGENT CARE FACILITY. THE DOCTOR DISCOVERED AND EXTRACTED 3 WAX GUARDS AND FLUSHED THE PATIENT'S EAR. PATIENT HAD NOT TOLD HIS MOTHER THE GOLD RING HAD FALLEN OUT OF HIS EARMOLD AND HAD CONTINUED PUTTING NEW WAXGUARDS IN THE EARMOLD. THE GOLD RING HAS FALLEN OUT OF THIS PATIENT'S EARMOLD BEFORE, IT WAS SERVICED WITH THIS PROBLEM (B)(6) 2022. PATIENT'S MOTHER ALSO MENTIONED THAT OUR CERUSTOP WAXGUARDS HAVE NEVER FIT IN HIS RIGHT EARMOLD, HIS DOCTOR HAS BEEN USING STARKEY (NOT ORIGINAL) WAXGUARDS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16282066 ↗