TruHearing HA TH ADVANCED 6 RIC LIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05714880146875), received between Mar 20, 2024 and Mar 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IN THIS EVENT, THE PATIENT HAD EXPERIENCED MULTIPLE INFECTIONS. HE WAS ORIGINALLY FITTED FOR HEARING AIDS ON (B)(6) 2023. PATIENT WAS SEEN TWICE BY ENT IN (B)(6) FOR OTAGILIA AND OTIDUS EXTERNA. PATIENT WAS PRESCRIBED EAR DROPS, ANTIBIOTICS AND PREDNISONE FOR TREATMENT. PER THE HEALTHCARE PROVIDER, PATIENT HAS NOT BEEN SEEN SINCE THE OCCURENCE AND WILL NO LONGER BE WEARING HEARING AIDS. RESULTS OF TECHNICAL INVESTIGATION FOUND THE RETURNED DEVICES HAVE BEEN INVESTIGATED WITHOUT ANY OBJECTIONS.IT IS UNLIKELY THAT NEW HEARING AID PRODUCTS CAN CONTAMINATE THE PATIENTS SKIN WITH BACTERIUM OR VIRUS WHICH CAN CAUSE AN OTITS. CLOSING THE EAR CANAL WITH EAR MOLDS OR DOMES, MIGHT SUPPORT AN EXISTING OTITIS INFECTION. USED DOMES OR SLEEVES MAY CLOSE THE EAR CANAL AND SUPPORT A HUMID CLIMATE WHICH MAY PROMOTE AN OTITIS. ALL MATERIALS WHICH ARE IN CONTACT WITH CUSTOMERS SKIN WERE TESTED FOR THEIR BIOCOMPATIBILITY BASED ON ISO-10993-1. NO FURTHER INVESTIGATION CAN BE DONE.

  Patient problems: Ear infection

  MAUDE report 18941188 ↗