Objective In February 2020, Advanced Bionics initiated a field action notice to remove the MS Ultra (V1) implant from circulation. In this study, we quantify a single site's incidence with device failure and examine the relationship between impedance change and declining speech perception. Study Design Retrospective/cohort study. Setting Tertiary healthcare center. Patients Forty-nine adult patients (52 devices) were implanted between October 2017 and December 2019, with the following exclusion criteria: 15%. Device failures were confirmed through analyses completed by the manufacturer. Results To date, 21% (11/52) of devices have met all three criteria for a confirmed failure with an average decline in speech perception of 27.7 ± 22%. The average length of time for detection of device failure was 21.9 ± 5 months postimplantation. An additional 7 devices (13%) are currently being monitored for failure but have not yet met full criteria. There was no predictive relationship between degree of impedance change and speech perception scores. Electrodes along the entire array (channels 1–16) can be affected. Conclusions Impedance values can be used as a reliable indicator of device malfunction, thus facilitating patient counseling and early intervention. No correlation was identified between impedance changes and speech perception scores.
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