OTICON OPN MINIRITE BTE (HEARING AIDS)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for OTICON OPN MINIRITE BTE (HEARING AIDS) manufactured by Oticon, Inc..

Event Text Entries

[105638958] 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. )
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076457
MDR Report Key7428394
Date Received2018-04-12
Date of Report2018-04-10
Date of Event2018-02-01
Date Added to Maude2018-04-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameOTICON OPN MINIRITE BTE (HEARING AIDS)
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2018-04-12
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOTICON, INC.

Device Sequence Number: 2

Brand NameOTICON OPN MINIRITE BTE (HEARING AIDS)
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2018-04-12
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerOTICON, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-12

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