MAUDE Adverse Event Report: COCHLEAR AMERICA HYBRID COCHLEAR IMPLANT

Model Number L24

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hearing Loss (1882); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 07/14/2016

Event Type  Injury  

Event Description

I was implanted with cochlear brand hybrid implant that was to retain my low frequency hearing while restoring high frequency ranges.Upon activation, i had absolutely no low frequencies remaining.I entered into the agreement under the impression that my odds were 15% of losing my lows.From what i've learned since the chances of losing low frequencies range from 44%-60%, not so good odds.In addition to losing my low frequencies, all voices sound as if they were auditioning for the part of (b)(6).To complete matters, unless i'm directly in front of and close to, i cannot understand speech.This has cost me my ability to work in an office environment earning a living.I left my position in the insurance industry because i cannot understand conversations.I can no longer hear conversations in an office environment and only about 50% of spoken words on a telephone.I have a regular cl on my other side that was helping me in the performance of my job.The hybrid from cochlear has contributed to me losing my job and contributed to a lack of social life.Being in public pieces creates a great deal of stress both on me and my partner.She is under a great deal of stress trying to cope with my inability to hear adequately.Initially i was told to my surgeon we would replace the hybrid with a standard cl.We received insurance company approval for that surgery and then 2 weeks prior to surgery, at my final pre-surgery consultation, the surgeon told me i would not benefit from another surgery.I feel like the hybrid technology has cost me (b)(6) due to lack of income from my profession.

• Brand Name: HYBRID COCHLEAR IMPLANT
• Type of Device: HYBRID COCHLEAR IMPLANT
• Manufacturer (Section D): COCHLEAR AMERICA
• MDR Report Key: 6834518
• MDR Text Key: 84401087
• Report Number: MW5071882
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: L24
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 84