MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; IMPLANT, HEARING, ACTIVE, MIDDLE EAR, TOTALLY IMPLANTED

Device Problems Labelling, Instructions for Use or Training Problem (1318); Battery Problem (2885); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Failure of Implant (1924); Unspecified Mental, Emotional or Behavioural Problem (4430); Total Hearing Loss (4473)

Event Date 09/01/2022

Event Type  Injury  

Event Description

I am a bilateral implantee with 2 esteem middle ear implants produced by envoy medical.It is a fully implantable battery-driven hearing device.It is not a cochlear implant.This device allows me to hear.The device is cemented in my mastoid bone and electrodes are attached to my middle ear.This device makes my natural hearing structure work better, so i have better hearing than i had with hearing aids.My complaint is not about the actual device.I reached out to the company to inform them i needed a new battery and was told they do not have any and do not know when they will be getting the parts they need for the battery.They claim it is a covid supply issue.Until this point, envoy had not notified any of its patients about this shortage.Since the esteem is attached to the middle ear, the middle ear does not work without the battery.I cannot hear without it.My right implant battery has died.I am completely deaf in my that ear.My left ear battery is older than my right implant and i do not know how much battery life i have left.Envoy has apologized, but says there is nothing they can do, "they don't have any".I have called around the country searching for anyone that may have these batteries, but i have been unsuccessful in locating anyone that can help me.If this was a covid supply chain issue, why did envoy not warn other people who have these implants so battery life could have been preserved ? i entrusted envoy medical to provide me with this hearing device and now i am facing the possibility of having no hearing at all.I cannot work without being able to hear.Since i have lost my right ear completely, i have been isolated and struggling at work and in my home life.It has been incredibly stressful.I am doing everything in my power to preserve my left battery as much as possible.There are no shortages in other implantable medical devices.What is happening with this company and why did they not alert people with these devices? would this be tolerated if this were a pacemaker? is there anything the fda can do to expedite the process of getting the parts that envoy needs so people don't needlessly lose their hearing? i am terrified and it has affected all aspects of my life.Fda safety report id# (b)(4).

• Brand Name: ESTEEM
• Type of Device: IMPLANT, HEARING, ACTIVE, MIDDLE EAR, TOTALLY IMPLANTED
• Manufacturer (Section D): ENVOY MEDICAL CORPORATION
• MDR Report Key: 15543438
• MDR Text Key: 301269493
• Report Number: MW5112427
• Device Sequence Number: 2
• Product Code: OAF
• 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: 09/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White