GN ReSound EY2ITC-D-HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296132263), received between Apr 27, 2022 and Apr 27, 2022 — 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.

• InjuryApr 27, 2022Material Fragmentation; Material Fragmentation

  THE USER REPORTED THAT THE SHELL OF THE HEARING AID BROKE SUDDENLY. THE HI WAS BROKEN IN THE EAR CANAL AND THEN THE USER WENT TO THE HOSPITAL FOR INSPECTION, THE INSPECTION RESULT IS "AURICLE AND CONCHA ARE SLIGHTLY RED AND SWOLLEN, SKIN LESIONS, BLOOD SCRABS AND TYMPANIC MEMBRANCE SCARS". THE USER MOVED THE BROKEN HI BY HIMSELF. THE REASON WHY THE PATIENT WENT TO THE HOSPITAL FOR EXAMINATION WAS THAT THE BROKEN SHELL CAUSED EAR CANAL BLEEDING. THERE WERE NO OTHER ACCIDENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Localized Skin Lesion

  MAUDE report 14217835 ↗