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

OBJECTIVE

To characterize the timing and likelihood of electrode failure in Advanced Bionics (AB) cochlear implants and assess long-term trends following the 2020 recall of HiRes Ultra and Ultra 3D models.

STUDY

DESIGN

Retrospective cohort study.

SETTING

Single tertiary academic medical center.

METHODS

We conducted a retrospective chart review of patients who received AB HiRes Ultra or Ultra 3D cochlear AB implants between January 2014 and February 2020. Patients who experienced device failure requiring revision surgery were identified. Demographics, implant date, failure status, and time to failure were recorded. Kaplan-Meier survival analysis was used to model cumulative failure risk over time.

RESULTS

A total of 140 AB implants were placed, with 24 (17.1%) device failures identified. The median time to failure was 3.6 years (range: 0.39-6.0 years). Median follow-up was 5.2 years (range: 0.1-10.7 years). There was no significant association between failure and gender, age, race/ethnicity, or laterality. Kaplan-Meier analysis demonstrated that 95% of failures occurred within the first 5.9 years, and the failure rate decreased to 2.1% per year after 5 years.

CONCLUSION

AB cochlear implant failures primarily occur within the first 5 years postimplantation, with significantly reduced risk beyond this period. These findings support long-term device stability and can inform patient counseling, expectations, and follow-up protocols.