MAUDE Adverse Event Report: COCHLEAR HYBRID L24

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hearing Impairment (1881); Therapeutic Effects, Unexpected (2099)

Event Date 12/07/2015

Event Type  Injury  

Event Description

I received the cochlear nucleas hybrid l24 implant in (b)(6) 2015.I am not receiving hearing benefits as indicated and now finding out that as i lose more residual hearing the device will need to be replaced because it was not designed properly.Doctors and the company itself are not advising implementation of this product anymore with new patients.Furthermore i'm hard pressed to find doctors or audiologists that can help improve upon this situation which enforces that this medical device isn't helping.I have become aware of others that have had similar issues.The companies claims of hearing better with this device compared to hearing aids have not come true for me.I have lost my life due to this surgery and it is permanent.If i chose to have surgery to receive a longer length electrode i risk losing all the hearing in that ear.I never identified myself as deaf before i received this implant.Hardly no one knew i had hearing issues.I wanted to hear better in noise and that is why i received this implant.I cannot hear better in noise.I can't even hear at the grocery story which wasn't the case before implantation.The l24 needs to be pulled because there is too much risk to the patient.I do not believe the company is supporting the patients that have received this implant because they don't want to admit a problem with it.

• Brand Name: HYBRID L24
• Type of Device: HYBRID L24
• Manufacturer (Section D): COCHLEAR
• MDR Report Key: 6646943
• MDR Text Key: 77864729
• Report Number: MW5070453
• 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

• Date FDA Received: 06/14/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 48 YR
• Patient Weight: 68