FDA Adverse Event Malfunction Summary report: N

AUDIEN ION HEARING AIDS

MDR report key: 22884053 · Received August 25, 2025

Report

Report Number
MW5175183
Event Type
Malfunction
Date Received
August 25, 2025
Date of Event
July 15, 2025
Report Date
August 19, 2025
Manufacturer
AUDIEN/BUDGET HEARING AIDS, LLC
Product Code
QUG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

DEVICE - ION HEARING AIDS MANUFACTURED BY AUDIEN. I PURCHASED HEARING AIDS FROM AUDIEN ONLINE ON (B)(6) 2025. THE STATED WARRANTY FOR THE PRODUCT IS 12 MONTHS. ON 7/15/2025 I REPORTED TO AUDIEN CUSTOMER SERVICE THAT THE LEFT HEARING AID WOULD NOT RECHARGE AND WAS UNUSABLE. THE CUSTOMER SERVICE CONFIRMED THE WARRANTY AND SUGGESTED THAT THE CHARGER WAS PROBABLY DEFECTIVE AND THEY WOULD SHIP ME A REPLACEMENT. ON (B)(6) 2025 THE REPLACEMENT CHARGER ARRIVED BUT THE HEARING AID WOULD NOT RECHARGE. ON 7/23/2025 I AGAIN CALLED AUDIEN AND TOLD THEM THE CHARGER WAS NOT THE PROBLEM AND THAT THE LEFT AID WAS NOT RECHARGING. SHE STATED THEY WOULD SEND ME A SHIPPING LABEL AND THAT I SHOULD RETURN BOTH AIDS AND BOTH CHARGERS AND ANY PACKAGING INFORMATION I HAD ON THE SET OF HEARING AIDS. ON 7/29/2025, I CALLED AUDIEN AGAIN AND TOLD THEM I HAD NOT YET RECEIVED THE SHIPPING LABEL AND THAT I WAS GROWING FRUSTRATED WITH THE SERVICE. WITHIN 5 MINUTES, THE SHIPPING LABEL (RGA) ARRIVED TWICE BY EMAIL. ON THE SAME DAY, 7/29/2025, I SHIPPED THE HEARING AIDS AND BOTH CHARGERS BACK TO AUDIEN AS INSTRUCTED BY USPS. THE USPS TRACKING NUMBER SHOWS THE PACKAGE WAS DELIVERED ON 8/4/2025. ON 8/6/2025, I SENT AN EMAIL TO AUDIEN REQUESTING STATUS OF MY HEARING AIDS AND RECEIVED A REQUEST FROM THEM FOR A VIDEO CALL TO BE HELD ON 8/13/2025 AT 12:40PM WITH THEIR (B)(4). ON 8/13/2025, I CONNECTED TO THE VIDEO CALL AS REQUESTED AND (B)(4) STATED SHE DID NOT KNOW WHAT CAUSED THE DELAY AND I HELD THE LINE WHILE SHE ATTEMPTED TO RESOLVE THE ISSUE. SHE WAS UNABLE TO RESOLVE THE ISSUE AND TOLD ME THAT I WOULD RECEIVE AN EMAIL WITH THAT INFORMATION BY 15:30. AS OF TODAY, 8/19/2025, I HAVE NOT RECEIVED THE EMAIL REPLY SO I CALLED AUDIEN AGAIN. THE AUDIEN REP TOLD ME THAT SHE COULD CONFIRM THAT THEY HAD RECEIVED MY HEARING AIDS AS I STATED AND THAT SHE WOULD CHECK WITH THAT DEPARTMENT. I HELD AGAIN WHILE SHE ATTEMPTED TO UNSUCCESSFULLY TO DO AND STATED SHE WOULD CONTACT ME WHEN IT WAS RESOLVED. I CONFIRMED MY EMAIL ADDRESS WITH HER AND TOLD HER TO NOTE THAT I WAS FILING A MEDWATCH FOR PRODUCT QUALITY AND SERVICE. COMPLAINT - POOR QUALITY, NO RESPONSIVE COMPANY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1108208 AUDIEN ION HEARING AIDS HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG AUDIEN/BUDGET HEARING AIDS, LLC

Patients

Seq Age Sex Outcome Treatment
1 78 YR Male