MAUDE Adverse Event Report: SOUND QUEST, LLC LIBERTY UNIVERSAL 128CH WL ANDROID BLACK; HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION

Model Number	5460
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report or other information submitted by hearing lab technology llc under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by hearing lab technology llc, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
Event or Problem Description
It was reported to the importer, by the end user, customer visited our clinic reporting discomfort and a burn on the ear, which the customer attributed to the hearing aid.Upon evaluation by the clinician, it was determined that the burn on the back of the ear was caused by a leaking hearing aid battery, resulting in a chemical burn.The customer stated that they plan to consult a physician regarding the injury.The hearing aid was received at the importer on (b)(6)2025, but the battery was not returned.

• Brand Name: LIBERTY UNIVERSAL 128CH WL ANDROID BLACK
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• Manufacturer (Section D): SOUND QUEST, LLC; 806 beaver st; west bristol PA 19007
• MDR Report Key: 21182152
• Report Number: 2523532-2025-00001
• Device Sequence Number: 4262832
• Product Code: OSM
• UDI-Device Identifier: 00812944028442
• UDI-Public: 00812944028442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025
• Report Date (Section F): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5460
• Device Catalogue Number: HLT-U128WLA-BK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2024
• Event Location: Other
• Date Report to Manufacturer: 01/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/17/2025