FDA Adverse Event Malfunction Summary report: N

WIDEX MOMENT

MDR report key: 23877844 · Received December 23, 2025

Report

Report Number
MW5181038
Event Type
Malfunction
Date Received
December 23, 2025
Date of Event
December 15, 2025
Report Date
December 16, 2025
Manufacturer
WS AUDIOLOGY USA, INC.
Product Code
OSM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HEARING AIDS SEEM TO GET STUCK WITH LOUD NOISE THAT IS MORE THAN ANNOYING. APPARENTLY, THIS IS A RESULT OF THE BLUETOOTH CONNECTION WITH MY PHONE. I GENERALLY HAVE TO DISABLE BLUETOOTH TO GET IT TO STOP. MY AUDIOLOGIST AND HEARING AID FITTERS HAVE TRIED TO ADDRESS THIS ISSUE BY CHANGING DIFFERENT SETTINGS ON MY PHONE. THESE CHANGES HAVE NOT HELPED. ANOTHER ISSUE IS THAT MY HEARING AIDS BEGAN GENERATING VERY HIGH-PITCHED SQUEAKING WHEN A REAL HIGH FREQUENCY NOISE HAPPENS. NO SETTINGS WERE MODIFIED WHEN THIS STARTED HAPPENING. A HEARING AID FITTER TRIED CHANGING MY HIGH FREQUENCY GAIN, BUT THAT HAS NOT HELPED. I DO NOT THINK THAT THESE TYPES OF PROBLEMS ARE BEING ADEQUATELY ADDRESSED BY THE MANUFACTURER. PT CODE: 4582. DEVICE CODE: 3273. REF REPORT: MW5181037.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2391313 WIDEX MOMENT HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM WS AUDIOLOGY USA, INC.

Patients

Seq Age Sex Outcome Treatment
1 66 YR Female