MAUDE Adverse Event Report: STARKEY LABORATORIES INC HEARING AID AUDIBEL

Device Problem Battery Problem (2885)

Patient Problem Hearing Loss (1882)

Event Type  malfunction  

Event Description

With the aid of insurance, i purchased hearing aids from audibel.The purchase was either 2014 or 2015.If the exact date is necessary i can find it.The left one.Serial number (b)(4), i have sent back for repair approximately a dozen times.The main complaint, very short battery life, for which it has been sent back for most of those times, has never been resolved.Several times the aid was returned with a card showing the aid passed a test for "battery drainage." i still have some of those cards.The implication is the aid is functioning properly.The aid looses power far too quickly, frequently without warning, and i loose hearing in that ear however, i have been told it is possible to address the aid to determine battery life.If that is true the audibel is deliberately using the wrong test.This appears to me to be at least deceptive and perhaps a fraud in interstate commerce.

• Brand Name: HEARING AID AUDIBEL
• Type of Device: HEARING AID AUDIBEL
• Manufacturer (Section D): STARKEY LABORATORIES INC
• MDR Report Key: 6428055
• MDR Text Key: 70785276
• Report Number: MW5068617
• Device Sequence Number: 1
• Product Code: LXB
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 100