GN Hearing 22830174Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296308712), received between Dec 14, 2023 and Dec 14, 2023 — 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 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.

• InjuryDec 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  BEST ESTIMATE DATE OF INCIDENT OCT2023. 15NOV2023 IT WAS REPORTED: USER HAS WORN HEARING AIDS FOR 1.5-2MTHS, AFTER 1-2 WEEKS USER GET SYMPTOMS STARTED WITH TINY BUMPS ON FOREHEAD THEN RADIATED WITH LARGER BUMPS BEHIND EARLOBES. PATIENT DOES NOT REPORT ANY PAIN, ITCHINESS, REDNESS, OR DISCOMFORT RELATED TO THE SYMPTOMS. BUMPS ARE BEHIND BOTH EARS. USEER DOES NOT HAVE HISTORY OF ALLERGY/HYPERSENSITIVITY. USER INQUIRED ABOUT MATERIALS TO EXPLAIN ISSUE. USER LIVES IN NY BUT WAS IN FL SO DID NOT SEE HIS NORMAL DERMATOLOGIST OR PHYSICIAN - SAW LOCAL DERM AND LOCAL PHYSICIAN'S ASSISTANT (PA). NO ALLERGY TESTING PERFORMED, DOES NOT WANT TO TAKE ANTIBIOTIC FROM DERM BUT USING TOPICAL STEROID CREAM FROM PA. WILL GET TESTING DONE AT HIS PHYSICIAN'S OR DERMATOLOGISTS OFFICE WHEN HE GETS HOME TO NY IF THEY RECOMMEND IT. PATIENT WANTS TO CONTINUE WEARING AIDS. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: Rash

  MAUDE report 18325454 ↗