Clin Exp Otorhinolaryngol.  2024 Feb;17(1):37-45. 10.21053/ceo.2023.00010.

Changes in Revision Cochlear Implantation and Device Failure Profiles

Affiliations
  • 1Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 2Hearing Research Laboratory, Samsung Medical Center, Seoul, Korea

Abstract


Objectives
. As cochlear implantation (CI) experiences rapid innovations and its indications expand, the characteristics of revision CI (RCI) are evolving. This study investigated changes in the RCI profile and explored their clinical implications.
Methods
. A retrospective chart review was conducted of all CIs performed at a tertiary medical institution between October 2001 and January 2023. The rates of and reasons for RCI were evaluated in relation to the manufacturer and device model. Kaplan-Meier analysis was employed to examine cumulative and device survival curves. Cumulative and device survival rates were additionally analyzed based on age group, period of primary CI, and manufacturer. A Cox proportional hazards model was employed to evaluate the association between RCI and the device manufacturer.
Results
. Among 1,430 CIs, 73 (5.1%) required RCI. The predominant reason for RCI was device failure (40 of 73 RCIs [54.8%]), with an overall device failure rate of 2.8%. This was followed by flap-associated problems and migration (nine of 73 RCIs each [12.3%]). Flap retention issues emerged as a new cause in three cases (two involving the CI 632 and one involving the SYNCHRONY 2 implant), and six instances of electrode tip fold-over arose (four for the CI 600 series and two for the CI 500 series). The overall 10-year cumulative and device survival rates were 93.4% and 95.8%, respectively. After excluding models with recall issues, significant differences in cumulative (P =0.010) and device (P =0.001) survival rates were observed across manufacturers.
Conclusion
. While the overall CI survival rate is stable, device failure persists as the predominant reason for RCI. Moreover, the types of complications leading to revision (including issues with flap retention and electrode tip fold-over) have shifted, particularly for newer implant models. Given the clinical importance of device failure and subsequent reoperation, clinicians should remain informed about and responsive to these trends.

Keyword

Cochlear Implant; Device Failure; Revision Surgery; Survival Rate

Figure

  • Fig. 1. Overall cumulative and device survival. (A) Before exclusion of models subject to recall. The excluded models were the CI 512, Clarion CII, HiRes 90K, and HiRes Ultra3D. (B) After exclusion. CI, cochlear implantation.

  • Fig. 2. Cumulative survival and device survival. (A) By age group. (B) By period of primary implantation. (C) By manufacturer. CI, cochlear implantation.


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