MAUDE Adverse Event Report: COCHLEAR AMERICAS HYBRID L24 COCHLEAR IMPLANT ARRAY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

Event Date 12/14/2014

Event Type  Injury  

Event Description

I was implanted with the cochlear hybrid l24 array (b)(6) 2014 and activated (b)(6) 2014.Upon activation i experienced severe sound distortion and continued to be told that was normal for the following 6 months.Upon the 6th month my audiologist turned off 8 electrodes which cut down the distortion in quiet rooms but even now, after seeking programming help from audiologists who participated in the fda study of the array, i still have severe distortion in somewhat very noisy settings.I'm also down to only having 8 electrodes turned on.This is not normal and there are a large number of us with the same complaints.Most who have lost 20 db or more of their low frequency residual hearing are the ones who are experiencing the same even though we were told by cochlear the array could be reprogrammed to cover low frequency loss.This is not the case and thanks to the misinformation, i have lost half of my low frequency hearing and will lose the rest upon revision surgery to obtain a longer array with the hopes of better sound quality.This needs to be brought out to the public and all those who were implanted with the l24.Not only am i finding surgeons are not recommending the array due to these issues (showing it's a larger problem than cochlear is letting on) but also that cochlear employees are secretly not recommending the array to candidates.When cochlear reps were approached, i was told there wasn't enough information to share at this point and any direct questions i asked about the number of people experiencing the same issues were completely avoided.Cover up.

• Brand Name: HYBRID L24 COCHLEAR IMPLANT ARRAY
• Type of Device: HYBRID L24 COCHLEAR IMPLANT ARRAY
• Manufacturer (Section D): COCHLEAR AMERICAS
• MDR Report Key: 6646884
• MDR Text Key: 77864732
• Report Number: MW5070449
• Device Sequence Number: 1
• Product Code: PGQ
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR