Early Failure Risk and Long-Term Outcomes of Advanced Bionics Electrode Devices Post-Recall

Sunday, October 12, 2025

9:42 AM - 9:48 AM EDT

Location: 244

Introduction: In February 2020, Advanced Bionics (AB) issued a recall for two cochlear implant models, the “HiRes Ultra” and “HiRes Ultra3D,” following reports of performance degradation linked to electrode failure. This device failure has been associated with low impedances in affected electrodes and has impacted speech perception and recognition. We aim to analyze the timing of failures, hypothesizing that the likelihood of failure decreases as the time from implantation increases.

Methods: A single-institution retrospective chart review was performed on patients implanted with an AB electrode from January 2014 to February 2020. Patients who experienced device failure and underwent a subsequent revision CI placement were identified. Data collection included demographics, time of implantation, implant status, and timing to failure. Kaplan-Meier curves were used to model the risk of implant failure over time.

Results: A total of 140 AB electrodes were implanted, with 22 (15.7%) experiencing device failure. The median follow-up time for patients was 5.14 years (range 0.08 - 10.6 years). There was no association with device failure and gender, age at implantation, race/ethnicity, or CI laterality. The median time to failure was 3.3 years (range 0.39 - 6.0 years), with 95% of electrodes failures occurring within 4.8 years. On Kaplan-Meier survival analysis, the additional risk of device failure beyond 5 years is 1.35%.

Conclusions: Our study demonstrates that AB electrode failures predominantly occur within the first five years post-implantation, and there is low risk for patients who have had their implant for more than five years. While this doesn’t preclude continued monitoring, these findings can improve patient counseling, expectations for device failures and guide clinical follow-up.

Presenting Author(s)

KL

Kalena H. Liu, BS

Medical Student
Thomas Jefferson University
Philadelphia, PA, United States

Disclosure information not submitted.

Co-Author(s)

LO

Lauren O'Brien, BA

Thomas Jefferson University, United States

Disclosure information not submitted.
Daniel J. Campbell, MD

Resident Physician
Thomas Jefferson University
Philadelphia, PA, United States

Disclosure information not submitted.
RC

Rebecca C. Chiffer, MD

Assistant Professor
Thomas Jefferson University
Philadelphia, PA, United States

Disclosure information not submitted.
TW

Thomas O. Willcox, Jr., MD

Associate Professor
TJUH Dept of OTO
Philadelphia, PA, United States

Disclosure information not submitted.

Senior Author(s)

Jacob B. Hunter, MD

Associate Professor
Thomas Jefferson University
Philadelphia, PA, United States

Disclosure information not submitted.