Beltone 19421005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819267993), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 injury.

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.

• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT STARTED FEELING IRRITATION AND PAIN IN THE EAR CANAL AFTER THE REPLACEMENT OF RECEIVER. THE PATIENT HAS BEEN WEARING THIS INSTRUMENT FOR APROX. 2 YEARS BEFORE THIS REC CHANGE. THE SKIN REACTION HAS BEEN CONFIRMED BY DOCTOR, THAT HAS PRESCRIBED ANTIBIOTICS. THE EAR IRRITATION HAS IMPROVED AFTER THE PATIENT STOPPED WEARING THE INSTRUMENT AND STARTED THE TREATMENT WITH ANTIBIOTICS. ENVIRONMENT: ACCORDING TO THE INFORMATION PROVIDED BY THE DISPENSER, THE REACTION DOES NOT SEEM TO BE CAUSED BY WEARING THE DEVICES IN A SPECIFIC ENVIRONMENT (HOME, OUTDOOR) THE PATIENT DOES NOT USE A CLEANING AGENT. THE PATIENT HAS WORN HEARING INSTRUMENTS BEFORE.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 12566989 ↗