Signia PURE 312 5AXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05714880154627), received between Jun 28, 2024 and Jun 28, 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.

• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IN THIS EVENT, PATIENT WAS REMOVING HEARING AID FROM EAR WHEN UNKOWNING TO THE USER, THE DOME HAD DETACHED FROM THE RECEIVER AND REMAINED IN EAR CANAL. PATIENT CONTINUED TO REINSERT HEARING AID FOR THE FOLLOWING DAYS, PUSHING THE DETACHED DOME DEEPER INTO EAR CANAL. PATIENT WENT TO ENT DOCTOR WHO FOUND THE DETACHED DOME LODGED IN EAR CANAL AND WAS ABLE TO REMOVE FROM EAR. USER REPORTED PAIN AND DISCOMFORT IN THE EAR. PATIENT WAS PRESCRIBED AN ANTIBIOTIC. RESULTS OF TECHNICAL INVESTIGATION: HEARING AIDS WITH ERU WAX GUARD WERE RETURNED FOR INVESTIGATION. DOME THAT WAS LODGED IN PATIENT'S EAR WAS NOT RETURNED. DEVICES THAT WERE RETURNED WERE TESTED AND ARE FUNCTIONING WITHIN SPECIFICATION. USER GUIDE INSTRUCTS PATIENT TO SEEK ASSISTANCE FROM MEDICAL PROFESSIONAL SHOULD A PIECE REMAIN IN THE EAR.

  Patient problems: Discomfort; Ear Pain

  MAUDE report 19632401 ↗