MAUDE Adverse Event Report: Harmony Speech Processor/Chorus Speech Processor; Implant, Cochlear

Model Number	CI5235
Medical Device Problem Codes	Compatibility Problem (2960); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	06/21/2026
Type of Reportable Event	Other
Event or Problem Description
Received a advanced bionics(ab) 1st generation cochlear implant(c1) in 1992.I participated in clinical trials that helped ab obtain fda approval.I have excellent results with this internal device.In order for the implant to function and allow me to hear external equipment is required.That is a headpiece with magnet, cable, speech processor, microphone and battery ab is discontinuing the making of all external parts that make the implanted device function.All of them can be replaced if they wear out or malfunction, but the internal devices does not work without all of those componets ab is no longer manufacturing any of those parts.They say that this is due to a computer chip issue, but they will continue to make those parts for the newer generation of implanted devices.The solution ab has to this is to do revision surgery.My feeling is that after 33 years and with the implanted device still functioning very well that there is not reason to have revision surgery to continue to hear from my left ear.I doubt that insurance would pay to have a working implant removed, there is a risk that of ossification has occurred that makes removing the existing implant and inserting a new one very complicated.Both my audiologist and surgeon do not think revision is a good idea.I also have some medical issues that make surgery more difficult.Ab does have care connect, and said they would support people that cannot have the revision, but they do not have the extra parts that are needed available and there is not indication that they will be manufacturing any more.I feel that the corporation has abandoned all of us that helped them get their start, outdated technology should not make it so that things like cables, head pieces and batteries can no longer be made, and backward engineering to support the existing devices.I have hearing test results from 5/26/25 but unable to copy and paste.Long term cochlear implant user with excellent hearing scores poor candidate for revision surgery.

• Brand Name: Harmony Speech Processor/Chorus Speech Processor
• Common Device Name: Implant, Cochlear
• MDR Report Key: 50515492
• Report Number: MW6001600
• Device Sequence Number: 9210293
• Product Code: MCM
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1992
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Lay User/Patient
• Device Model Number: CI5235
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2026
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 170 LB
• Patient Race: White