FDA Adverse Event Malfunction Summary report: N

AUDIBEL A4 I GOLD 22 CHANNEL HEARING AID FOR RIGHT EAR

MDR report key: 16410466 · Received February 17, 2023

Report

Report Number
MW5115061
Event Type
Malfunction
Date Received
February 17, 2023
Date of Event
November 30, 2022
Report Date
February 15, 2023
Manufacturer
STARKEY LABORATORIES, INC.
Product Code
ESD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2022 I VISITED THE AUDIBLE OFFICE IN(B)(6) FOR A HEARING AID CHECK UP. I HAD PURCHASED MY STATE OF THE ART 22 CHANNEL - HEARING AID IN 2018 FOR (B)(6). MY HEARING HAD WORSENED SINCE I HAD COVID IN OCTOBER. I USE JUST ONE HEARING AID BECAUSE THE OTHER EAR CANNOT BE HELPED WITH ONE AND REMAINS TOTALLY DEAF. AFTER TESTING ME AGAIN (B)(6) TOLD ME THAT I WOULD NEED A NEW HEATING AID. HE SAID MY CURRENT HEARING AID HAD TECHNOLOGY THAT WAS OUTDATED WHEN I BOUGHT IT AND THAT HE COULD NO LONGER GET INTO HIS COMPUTER TO UPDATE THE SOFTWARE. HE TOLD ME THAT HEARING AIDS NEED TO BE REPURCHASED EVERY 3 TO 4 YEARS DUE TO SWIFT CHANGES IN TECHNOLOGY. I ASKED HIM HOW SENIORS COULD AFFORD TO SPEND THAT KIND OF MONEY THAT OFTEN AND HE TOLD ME THAT MOST RECENTLY PEOPLE WERE USING THEIR (B)(6) INSURANCE MONEY. WHEN I PURCHASED THIS FROM (B)(6) IN 2018, I WAS TOLD THAT I WAS BUYING A STATE OF THE ART HEARING AID THAT COULD BE ADJUSTED AS NEEDED. SINCE THIS EVEN I HAVE RESEARCHED AUDIBEL FURTHER AND FOUND OUT THE FOLLOWING. AUDIBEL SELLS A "CLOSED SYSTEM" THAT NO ONE ELSE CAN GET INTO TO UPDATE CHANGING HEARING NEEDS IN THE FUTURE THUS LOCKING SENIORS INTO FALSELY CREATED OBSOLESCENCE AT THEIR WHIM. EVEN THOUGH THEIR PUBLISHED "PLATINUM CARE PROMISE" ASSURES BUYERS THAT THEY "CREATE A LONG-TERM TREATMENT PLAN, DEFINING FOLLOW-UP APPOINTMENTS, REGULAR ONGOING EVALUATIONS AND ANY ADDITIONAL CARE THAT YOU MAY NEED TO MAKE SURE YOU STAY SATISFIED WITH YOUR HEARING IN THE YEARS TO COME." AS A RETIRED SENIOR I CAN'T AFFORD A NEW HEARING AID EVERY THREE TO FIVE YEARS. PLEASE DO SOMETHING TO REQUIRE THIS COMPANY TO SERVICE ITS PRODUCTS. ALSO THEY SHOULD DISCLOSE UP FRONT THEIR PLANNED 3 TO 5 YEAR OBSOLESCENCE TO CONSUMERS. THANKS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1677305 AUDIBEL A4 I GOLD 22 CHANNEL HEARING AID FOR RIGHT EAR HEARING AID, AIR-CONDUCTION, PRESCRIPTION ESD STARKEY LABORATORIES, INC. RIC

Patients

Seq Age Sex Outcome Treatment
1 72 YR Female