A Multi-Institutional Analysis of Device Failures in a Recent Cochlear Implant Series

Abstract

Objective: To assess Advanced Bionics (AB) HiRes Ultra and Ultra 3D initial version (V1) cochlear implant electrode failures over time at four large cochlear implant programs.

Study design: Retrospective cohort.

Setting: Four tertiary referral centers.

Patients: Patients receiving AB HiRes Ultra and Ultra 3D initial version (V1) devices as of December 31, 2022.

Main outcome measures: Failure rate, revision surgery, speech recognition scores.

Results: Over a span of 7 years, 205 (42.6%) of 483 implanted V1 devices have failed. Device failure rate varied across institutions from 32 to 67%. Of the 205 detected failures, 163 (79%) have undergone revision surgery, with 94% of revisions being performed with Advanced Bionics devices. Average time from implantation to diagnosis of device failure was 2.7 ± 1.2 years. Most patients (89.8%) with available testing were matched or exceeded their best prefailure speech performance after implant revision. After revision, patients had an average CNC score improvement of 24.7 percentage points over their most recent pre-revision scores and demonstrated average datalogging of 12.7 ± 4.1 h/d at most recent evaluation.

Conclusions: Comparison of patients across multiple high-volume implant centers confirms the presence of ongoing device failures. There is variability across institutions in the rate of revision surgery once a patient is diagnosed with a V1 device failure, as well as in the rate of device failure detection. Inter-institutional variability in failure rates may be explained by the variation in the routine use of electrical field imaging. Reimplantation with a new device typically results in a return to prefailure peak performance.

Professional practice gap educational need: To our knowledge, a comparison of AB HiRes (V1) device failures across multiple institutions has not been conducted.

Learning objective: To identify device failure rate across multiple institutions with different testing protocols.

Desired result: Providers will have an improved understanding of the trajectory of device failures for HiRes (V1) devices over time.

Level of evidence: Level IV-Historical cohort or case-controlled studies.

Indicate irb or iacuc: IRB #230017; IRB #22-000183; IRB #STU-032018-085; IRB #H-49479.

Keywords: Cochlear implants; Device failure; Surgical outcomes.