(422) Recalled HiRes Ultra Cochlear Implants Demonstrate a 73% Failure Rate

Introduction: In 2020, Advanced Bionics announced a recall of V1 series HiRes Ultra and HiRes Ultra 3D cochlear implant models due to hearing degradation. Classifying device failures proves challenging due to the high incidence of “soft failures,” whereby the cochlear implant functions according to manufacturer software, but the patient does not perform at the expected speech perception outcome threshold. This study evaluates the rate of Advanced Bionics HiRes cochlear implant failures at the University of Florida with special attention focused on the longitudinal information required to diagnose soft failures.

Methods: A retrospective chart review was performed for all patients implanted with a V1 HiRes Ultra or HiRes Ultra 3D cochlear implant at UF Health Gainesville. Devices failures were evaluated in two respects: hard failures and soft failures. Hard failures are defined as devices that will not power on, and no stimulation can be achieved. Soft failures are defined as declines in speech perception outcomes despite external equipment exchange and mapping/programming adjustments.

Results: 15 HiRes Ultra and 3 HiRes Ultra 3D devices were implanted. Mean age at implantation was 68.5 years old. 73% of HiRes Ultra devices exhibited soft failures (11/15), while there were no HiRes Ultra 3D device failures. There were no hard failures across either device. Failed devices were implanted from December 6, 2016 to January 28, 2020. Median time to failure was 2 years and 7 months. 73% of patients with device failures had successful revision surgeries with V2 HiRes Ultra devices (8/11). The remaining 27% declined revision or were lost to follow up (3/11).

Conclusions: Long-term follow up of patients implanted with recalled Advanced Bionics devices demonstrates an alarming rate of soft failures. Audiologists should regularly monitor speech perception outcomes, allowing for early intervention in cases of cochlear implant failure.