GN ReSound LT9ITC-DW-HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296142514), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

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.

• MalfunctionNov 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  HAS MAKING LOUD SHRILL FEEDBACK SOUND LIKE AN AIRPLANE TAKING OFF, AFTER COMING BACK FROM REPAIR. AIDS SENT IN FOR REPAIR FOR THE SAME REASON AND ARE BACK AND DOING THE SAME THING. DID NOT HAPPEN IN THE OFFICE, BUT STARTED ABOUT AN HOUR AFTER GETTING HOME. AIDS WERE IN EARS FOR 2-3 MINS BEFORE THEY WERE PULLED OUT. THIS CAUSED THE PATIENT PAIN AND A HEADACHE WHICH WAS GONE AFTER TAKING MEDICINE. NOTE: ONLY THE RECEIVER WAS REPLACED WHEN REPAIRED PER THE HCP AND THE HCP DID NOT CALIBRATE THE DEVICES AFTER THE AIDS CAME BACK FROM REPAIR. SHE ONLY SAVED THE PREVIOUS SETTINGS FROM THE DATABASE. ADVISED HCP THAT THE AIDS DO NEED TO BE CALIBRATED WHEN THEY COME BACK FROM REPAIR. PATIENT IS ON PHONE WITH THE HCP. ADVISED HCP THAT THE PATIENT SHOULD NOT BE WEARING THE DEVICES AT ALL. AIDS TO BE SENT BACK TO QE. COMPLAINT CREATED. SPOKE WITH EMIE HER ISR, WHO RECOMMENDED SHE SPEAK TO (B)(6) RE: HOW REPAIR OR REPLACEMENT OF THE DEVICE. QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? POTENTIALLY YES. HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO. PLEASE CHOOSE THE DURATION OF THE SOUND? MORE THAN 10 SECONDS (2--3 MINUTES) WHAT TYPE OF RE

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10905098 ↗