Signia Pure Charge&GoRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05714880119565), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryMar 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IN THIS EVENT, HEALTH CARE PROVIDER REPORTED THAT PATIENT HAD PART OF THE RECEIVER AND TIP OF THEIR HEARING AID STUCK IN HIS EAR CANAL. (UNKNOWN HOW LONG THEY WERE STUCK IN PT'S EAR) PATIENT WENT TO URGENT CARE THEN TO THE EMERGENCY ROOM TO HAVE REMOVED, AND THEY WERE UNABLE TO REMOVE FROM PATIENT'S EAR. PATIENT WAS THEN SENT TO MASS EYE AND EAR, WHERE PATIENT WAS GIVEN ANTI-ANXIETY MEDICATION AND THE TIP/RECEIVER WAS REMOVED FROM HIS EAR WITH USE OF NUMBING MEDICATION. DEVICE WAS NOT RETURNED BY USER FOR INVESTIGATION. INVESTIGATORS TESTED 30 SAMPLES OF THE EAR TIP DOME AND EACH SAMPLE MET THE PULL TEST REQUIREMENTS (WITHSTAND 400G LOAD LONGER THAN 10 SECONDS WITHOUT FALLING OFF). INSTRUCTIONS FOR USE ARE ILLUSTRATED ON THE PRODUCT PACKAGING TO ENSURE PROPER INSERTION OF EARTIP 3.0 PRIOR TO USE. RECOMMEND USER TO FOLLOW THE USER GUIDE INSTRUCTION TO CHANGE THE EARTIP 3.0 REGULARLY TO AVOID ANY INCIDENT.

  Patient problems: Discomfort

  MAUDE report 18933278 ↗