GN ReSound PZ8ITE-DW-MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296190584), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗