Beltone 21581205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296205202), received between Nov 11, 2022 and Jul 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Biocompatibility; Biocompatibility

  DATE OF INCIDENT (B)(6) 2023. (B)(6) 2023 IT WAS REPORTED: A USER HAD A POTENTIAL REACTION TO A SMALL CLOSE DOME USED WITH A RELY 3/63 AND MP RECEIVER. USER HAS SYMPTOMS OF REDNESS AND IRRITATION IN THE EAR CANAL. USER HAS BEEN IN CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER (MD) WHOM SAID DOME WAS IMPROPERLY FITTED AND PRESCRIBED STEROIDS. NO FURTHER INFORMATION EXPECTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17412286 ↗
• MalfunctionNov 11, 2022Overheating of Device; Overheating of Device

  09 NOV 2022 IT WAS REPORTED - THE HEARING AID WAS DESCRIBED AS PARTIALLY MELTED FROM CHARGER USE. THE PATIENT WAS NOT HARMED. NO PROPERTY DAMAGE. THE CHARGER IS REPORTED AS ABOUT 1 YEAR OLD. THE REPLACEMENT(S) SHIPPED TO CUSTOMER ON 17 OCT 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779008 ↗