Signia INSIO 7AX C&GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05714880148688), received between Mar 12, 2024 and Mar 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 12, 2024Break; Break

  IN THIS EVENT, PATIENT WAS WORKING OUTSIDE ON HIS TRUCK, TURNED AND HEARD A LOUD CRACK AND POP. PATIENT STATES THAT SOMETHING DIDN'T FEEL RIGHT, HE REACHED UP TO TAP THE HEARING AID TO READJUST AND THERE WAS BLOOD POURING ALONG THE SIDE OF HIS FACE. HIS HEARING AID HAD SHATTERED INTO PIECES WHILE STILL CONNECTED TO HIS EAR. THERE WAS MEDICAL INTERVENTION AND INJURY AS STATED IN THE COMPLAINT FILE. PATIENT WENT TO CLINIC WHERE THE HCP OBSERVED 2 LACERATIONS IN THE CONCHA NEAR THE APERTURE OF THE CANAL AND OTOSCOPY REVEALED EVIDENCE OF BLOOD TO THE SECOND BEND. HCP ADVISED PATIENT TO GO TO THE EMERGENCY ROOM, BUT PATIENT DID NOT. PATIENT INFORMED HCP THE NEXT DAY THAT THERE ARE NO LACERATIONS OR BURNING IN THE EAR CANAL, ALTHOUGH THERE IS DRIED BLOOD IN THE CANAL THAT THE PATIENT HAS BEEN REMOVING AT HOME. INVESTIGATION RESULTS: RESULTS FROM TECHINICAL INVESTIGATION FOUND THE RETURNED DEVICE HAD BEEN MANIPULATED; THERE WAS A VISIBLE MARKING OF PENETRATION WITH SHARP/HARD OBJECT ON THE FACEPLATE AND LACQUERED SHELL HAD BEEN GRINDED DOWN. THIS MANIPULATION MAY HAVE COMPROMISED THE INTEGRITY OF THE SHELL AND LEAD DIRECTLY TO THE DESCRIBED FAILURE (DEVICE BROKE INTO PIECES) WHICH WEAKENE

  Patient problems: Laceration(s)

  MAUDE report 18888251 ↗