ANS021 - HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition Outcomes
Sunday, May 1, 2022
7:36 AM – 7:43 AM CT
Location: Landmark A
Nathan R. Lindquist, MD
Nathan D. Cass, MD
Ankita Patro, MD
Rene H. Gifford, PhD
David S. Haynes, MD, MMHC
Elizabeth L. Perkins, MD
Jourdan T. Holder, AuD, PhD
Clinical Fellow Vanderbilt University Medical Center Nashville, Tennessee
Objective: To report Advanced Bionics Ultra and Ultra 3D (V1) cochlear implant (CI) electrode failures and revision speech recognition outcomes for patients at a large CI program.
Study Design: Retrospective case series.
Setting: Tertiary referral center.
Patients: Patients who underwent cochlear implantation with HiRes™ Ultra (v1) or Ultra 3D (v1).
Main Outcome Measures: Failure rate, revision surgery, speech recognition scores.
Results: As of September 21, 2021, 65 (21.1%) of the 308 implanted devices were known failures, with 61 (19.8%) definitively associated with the recent voluntary field corrective action (FCA). The overall failure rate for adults (18.6%) was lower than the pediatric (26.9%) failure rate (p = 0.127). Average time to device failure was 2.2 ± 1.1 years. 47 patients (77%) completed revision surgery. For adults, there was no significant difference (p = 0.96) between best pre-revision speech recognition scores (median CNC = 62%, SD = 23%) and most recent post-revision performance (median CNC = 54%, SD = 27%). 79% of patients recovered to within 15 percentage points of their prerevision scores at last follow-up (median = 7.1 months).
Conclusions: A significant number of patients were identified with hard failures of the Ultra (v1) and Ultra 3D (v1) devices. This may be due to our institution’s diligent use of electrical field imaging (EFI) to confirm device failure, which is not ubiquitously available. Despite the high failure rate, the majority of patients achieve speech recognition scores similar to pre-failure performance after revision CI surgery.
*Professional Practice Gap & Educational Need: Manufacturer initiated CI device recalls are relatively uncommon, withthe majority of reliability and failure data only available through post-explant data through manufacturer device analysis and reliability reporting. Consequently, clinical data regarding active recalls and device failures may improve patient counseling with regards to failure rate and post-revision speech recognition outcomes.
*Learning Objective:
For the recent HiRes Ultra and Ultra 3D series recall:
1. Quantify and characterize such CI failures at a large CI center, and
2. Understand the post-revision speech recognition outcome scores for improved clinical decision making and patient counseling.
*Desired Result: Surgeons and audiologists will use these clinical data from the recent HiRes Ultra and Ultra 3D series to quantify and characterize this type of CI failure and implement their knowledge regarding post-revision speech recognition outcome scores for improved clinical decision making and patient counseling.
*Level of Evidence: Level V
*Indicate IRB or IACUC: Vanderbilt University Medical Center IRB# 211355