FDA Adverse Event Malfunction Summary report: N

SMART U OTC HEARING AID

MDR report key: 17692122 · Received September 5, 2023

Report

Report Number
MW5145224
Event Type
Malfunction
Date Received
September 5, 2023
Date of Event
August 19, 2023
Report Date
August 31, 2023
Manufacturer
XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.
Product Code
QUG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I ORDERED HEARING AIDS (B)(6) 2023 FROM CHOSGOHEALTH.COM AND RECEIVED THE PRODUCT (B)(6) 2023 FROM A COMPANY CALLED RETONE. I WAS VERY PLEASED WITH THE SMALL SIZE AND ANXIOUS TO TRY THEM. PLACED IN THE CHARGER AS PER INSTRUCTIONS BUT THE LIGHTS THAT WERE SUPPOSED TO LIGHT UP WHEN PUT ON CHARGER ONLY LITE UP ON THE LEFT SIDE. REPOSITIONED RIGHT AID NUMEROUS TIMES BUT LIGHT NEVER CAME ON. WAITED 24 HOURS AND PLACED AIDS IN EARS AND RIGHT AID WAS NOT WORKING ONLY THE LEFT ONE WAS WORKING, AND I WAS DISAPPOINTED AT HOW UNCOMFORTABLE THEY WERE. I CURRENTLY HAVE EARGOES WHICH ARE VERY COMFORTABLE, SO THIS WAS NOT MY FIRST RODEO WITH CIC HEARING AIDS. FOR THE ABOVE REASONS I WISH TO RETURN THE RETONE HEARING AIDS TO CHOSGOHEALTH.COM FOR A REFUND OF MY (B)(6) AS THEY HAVE A 45-DAY RETURN POLICY IF NOT SATISFIED. I HAVE BEEN BACK AND FORTH WITH CHOSGO WITH NO RESULTS AND RETONE NEVER RESPONDED WHEN I REACHED OUT TO THEM. THE ONLY REASON FOR NOT RETURNING TO EARGOS IS BECAUSE OF THE COST TO UPGRADE MY CURRENT AIDS, AND WAS HOPING THE CHOSGO AIDS WOULD BE A GOOD ALTERNATIVE. LESSON LEARNED, STICK WITH WHAT YOU KNOW IS GOOD EVEN IF A LITTLE MORE COSTLY. I HOPE YOU CAN HELP ME RESOLVE THIS ISSUE. THE LATEST FROM CHOSGO IS THEY WANT TO SEND ME A NEW SET AFTER I RETURN THE DEFECTIVE ONES, BUT I JUST WANT TO RETURN THEM AND GET MY MONEY BACK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1379983 SMART U OTC HEARING AID HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.

Patients

Seq Age Sex Outcome Treatment
1 80 YR Female CALCIUM.| FLUOXETINE.| GLUCOSAMINE.| MVI.| OMEGA 369.| PRIMIDONE.| QUERCETIN.| RHOPRESSA EYE DROPS.| XALATAN EYE DROPS.