MAUDE Adverse Event Report: STARKEY LABORATORIES, INC. HEARING AID

Model Number SOUNDSTEN 7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/16/2015

Event Type  malfunction  

Event Description

Hearing aids cause soreness and swelling and hurt.Numerous adjustments have been made and the problems continue.Dates of use: (b)(6) 2015 - (b)(6) 2016.Diagnosis or reason for use: hearing loss.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.

• Brand Name: HEARING AID
• Type of Device: HEARING AID
• Manufacturer (Section D): STARKEY LABORATORIES, INC.
• MDR Report Key: 6629575
• MDR Text Key: 77284656
• Report Number: MW5070259
• Device Sequence Number: 1
• Product Code: LXB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SOUNDSTEN 7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73