FDA Adverse Event Malfunction Summary report: N

OTICON OPN MINIRITE BTE (HEARING AIDS)

MDR report key: 7428394 · Received April 12, 2018

Report

Report Number
MW5076457
Event Type
Malfunction
Date Received
April 12, 2018
Date of Event
February 1, 2018
Report Date
April 10, 2018
Manufacturer
OTICON, INC.
Product Code
OSM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN (B)(6) 2017, I PURCHASED THE OPN MINIRITE HEARING DEVICES WITH THE RECHARGEABLE BATTERIES FROM AN AUTHORIZED HEARING CENTER AT A COST EXCEEDING (B)(6). SHORTLY AFTER RECEIVING THE DEVICES, ONE OF THE RECHARGEABLE BATTERIES STARTED TO FAIL. WITH A FULL CHARGE, THE BATTERY IN ONE OF THE HEARING DEVICES WILL LAST ALL DAY (12+ HRS), WHILE THE BATTERY IN THE OTHER HEARING DEVICES RUNS OUT AND FAILS AFTER 5-6 HRS. I REPORTED THIS ISSUE TO MY HEARING CENTER AND THEY SPOKE WITH SOMEONE AT OTICON WHO SAID THERE IS A PROBLEM WITH THE RECHARGEABLE DOORS ON THE HEARING DEVICES. OTICON SAID REPLACEMENT DOORS AND BATTERIES WOULD BE SENT TO REPAIR THE DEFECT, BUT NOW MONTHS LATER I AM STILL WAITING. I DO NOT KNOW WHAT IS DEFECTIVE OR BROKEN ON THE BATTERY DOORS, BUT I DO KNOW THAT MY ISSUE IS RELATED TO A SINGLE DEFECTIVE RECHARGEABLE BATTERY. I CAN SWAP THE BATTERIES BETWEEN HEARING DEVICES, AND THE PROBLEM ALWAYS FOLLOWS THE BATTERY. I HAVE TRIED THIS SEVERAL TIMES, RECHARGED AND RAN THE BATTERIES DEAD, AND NO MATTER WHAT OTHER VARIABLE I TRY THE ISSUE IS THAT THE SAME BATTERY ALWAYS FAILS. THE ISSUE DOES NOT SEEM TO BE CAUSED BY THE HEARING DEVICE OR BATTERY DOORS, JUST A FAILING BATTERY. I HAVE ASKED MY HEARING PROFESSIONAL FOR A REPLACEMENT RECHARGEABLE BATTERY, BUT THEY SAID THEY ARE BEING INSTRUCTED BY OTICON TO WAIT FOR DOOR REPLACEMENT AND AT THAT TIME NEW RECHARGEABLE BATTERIES WILL BE ISSUED. THAT IS A FINE GAME PLAN IF THE REPLACEMENT WAS SWIFT, BUT IT HAS NOW BEEN DELAYED BY MONTHS. SINCE I HAVE OWNED THE HEARING DEVICE I HAVE NEVER BEEN ABLE TO USE THE RECHARGEABLE FEATURE AS ADVERTISED. MY HEARING PROFESSIONAL HAS DONE WHAT THEY CAN, BUT THEIR REQUESTS ARE APPARENTLY BEING IGNORED OR REJECTED BY OTICON. REGARDLESS OF WHAT OTICON THINKS IS THE RIGHT PROCESS TO REMEDY THE SITUATION, REFUSING TO PROVIDE REPLACEMENT RECHARGEABLE BATTERIES ON THE SPOT TO CUSTOMERS WITH DEFECTIVE BATTERIES STILL UNDER WARRANTY, AND CONTINUING TO DELAY IMPLEMENTING A REAL SOLUTION TO THE DEFECT FOR MONTHS IS NOT ACCEPTABLE. THE STANDARD BATTERIES DO WORK, BUT ONE OF THE PRIMARY REASON I PURCHASED THE OTICON PRODUCT WAS FOR THE RECHARGEABLE BATTERY FEATURE. I BELIEVE OTICON IS STILL SELLING THESE PRODUCTS EVEN THOUGH THERE IS A KNOWN DEFECT WITH THE BATTERY DOOR. CUSTOMERS SHOULD NOT HAVE TO WAIT INDEFINITELY FOR A SOLUTION. OTICON CAN CONTINUE TO WORK ON FIXING THE DOOR ISSUE, BUT THEY SHOULD BE REPLACING DEFECTIVE RECHARGEABLE BATTERIES UNTIL THE ISSUES IS RESOLVED PERMANENTLY (PRESUMABLY WITH THE BATTERY DOOR DEFECT FIXED.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
267099 OTICON OPN MINIRITE BTE (HEARING AIDS) HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM OTICON, INC.
267100 OTICON OPN MINIRITE BTE (HEARING AIDS) HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM OTICON, INC.

Patients

Seq Age Sex Outcome Treatment
1 53 YR