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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STARKEY LABORATORIES INC HEARING AID AUDIBEL

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STARKEY LABORATORIES INC HEARING AID AUDIBEL Back to Search Results
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.

 
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Brand NameHEARING AID AUDIBEL
Type of DeviceHEARING AID AUDIBEL
Manufacturer (Section D)
STARKEY LABORATORIES INC
MDR Report Key6428055
MDR Text Key70785276
Report NumberMW5068617
Device Sequence Number1
Product Code LXB
Combination Product (Y/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 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2017
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
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

Patient TREATMENT DATA
Date Received: 03/20/2017 Patient Sequence Number: 1
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