Beltone AY2ITC-D-UPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296131334), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• InjurySep 21, 2021Material Fragmentation; Material Fragmentation

  DESCRIPTION OF EVENT FROM INITIAL REPORTER: SHELL OF THE HEARING INSTRUMENT (HI) BROKE WHEN THE CUSTOMER USING THE DEVICE. ADDITIONAL INFORMATION PROVIDED 07APR2021: WHAT IS MEANT BY "HI BROKE IN THE EAR CANAL?" AS CONFIRMED BY DISPENSER, THE SHELL OF THE HI BROKE WHEN THE CUSTOMER USING THE DEVICE. DID THE BROKEN HI CAUSE THE BLEEDING AND SWELLING OF EAR CANAL OR DID THE REMOVAL? THE BROKEN HI CAUSED THE BLEEDING AND SWELLING. WHO REMOVED THE HI FROM THE EAR CANAL? WAS THERE ANY COMPLICATION DURING THE REMOVAL? THE USER'S PARENT REMOVED THE HI. NO COMPLICATIONS. THE PATIENT IS NOT RECOVERED YET - DUE TO THE BLEEDING? THE PATIENT STOPPED BLEEDING ON THE SAME DAY. THE EAR CANAL WALL WAS SWOLLEN AND PAINFUL WHEN HE WENT TO THE DOCTOR THE NEXT DAY. DRUGS IS PRESCRIBED TO THE PATIENT, DUE TO A POSSIBLE INFECTION OR? THE DOCTOR PRESCRIBED AN ANTI-INFLAMMATORY DRUG FOR EAR DROPS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema

  MAUDE report 12504570 ↗