Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience

Area of Science:

• Otorhinolaryngology
• Biomedical Engineering
• Neuroscience

Background:

• Advanced Bionics (AB) recalled HiRes Ultra and HiRes Ultra 3D cochlear implant (CI) models in 2020 due to hearing degradation reports.
• Device failures in CI recipients necessitate understanding clinical parameters and patient features.

Purpose of the Study:

• To examine clinical parameters and patient features in cases of cochlear implant device failure.
• To evaluate hearing outcomes after revision cochlear implantation in patients with recalled AB devices.

Main Methods:

• Retrospective analysis of 52 patients who underwent revision CI placement between December 2019 and November 2021.
• Assessment of hearing performance using Consonant-Nucleus-Consonant scores, phoneme recognition, and pure-tone average thresholds.
• Evaluation of electrical field imaging and device impedance measurements.

Main Results:

• Hearing performance significantly declined before revision surgery but recovered after revision CI placement.
• Patients achieved peak hearing performance significantly faster after revision CI (53.4 days) compared to primary CI (260.6 days).
• Abnormalities in electrical field imaging and device impedance were noted in the basal electrodes (9-16).

Conclusions:

• Hearing performance degradation in recalled AB Ultra devices is linked to basal electrode array issues.
• Revision cochlear implantation yields robust outcomes, indicating the need for ongoing patient monitoring and support for reimplantation.
• Identifying the specific electrode involvement in device failure is crucial for future CI development and patient management.