MAUDE Adverse Event Report: STARKEY HEARING AID, LEFT EAR

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.

• Brand Name: HEARING AID, LEFT EAR
• Type of Device: HEARING AID, LEFT EAR
• Manufacturer (Section D): STARKEY
• MDR Report Key: 6885818
• MDR Text Key: 87302546
• Report Number: MW5072287
• Device Sequence Number: 0
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/22/2017
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MUSE 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