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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STARKEY HEARING AID, LEFT EAR

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STARKEY HEARING AID, LEFT EAR Back to Search Results
Model Number MUSE I 2400
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2017
Event Type  Malfunction  
Event Description

Purchased new hearing aides in (b)(6) 2017. My left hearing aide failed in (b)(6) 2017 and was reworked by starkey. My left hearing aide has now failed again. Each time i am without my hearing for weeks. It has been difficult to get permanent resolution or anything in writing to what will be done to resolve the issue.

 
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Brand NameHEARING AID, LEFT EAR
Type of DeviceHEARING AID, LEFT EAR
Manufacturer (Section D)
STARKEY
MDR Report Key6885818
MDR Text Key87302546
Report NumberMW5072287
Device Sequence Number0
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2017
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMUSE I 2400
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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