Objective: Analyze indications, findings, and outcomes of revision procedures for a totally implantable active middle ear implant (AMEI) over the past 17 years.
Study design: Retrospective review.
Setting: Single institution, private practice setting.
Subjects: Adult patients using a totally implantable AMEI called the Esteem middle ear implant by Envoy Medical who needed revision to their original implant between 2005 and 2022. Thirty-nine patients had 60 revision procedures.
Intervention: History of a totally implantable AMEI revision procedure. Indications for revision were related to either surgical wound issues or reduced device function.
Outcome measures: Device diagnostics, audiometric outcomes, and documented subjective report.
Results: Surgical site wound issues were readily corrected in the majority of patients; most had risk factors for wound breakdown. For sterile wound dehiscence, it was not always necessary to remove the sound processor for an extended time to promote healing. Outcomes for revision procedures because of device issues ranged from 31 to 100% success rate, depending on the cause of issue. The most common indication for revision was reduced device function caused by scar band and/or fibrotic tissue accumulation in the middle ear.
Conclusion: Revision of fully implantable AMEI can be successful for many indications. Appropriate preoperative device troubleshooting and medical evaluation is helpful in identifying the issue and determining surgical approach. Suboptimal device function and feedback can sometimes be improved by removing tissue around the implant, although permanency of this procedure varies among patients.
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