Impedance Change as an Indicator of Cochlear Implant Failure.

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: <18 years of age, medical/surgical failures, and lack of English-language proficiency.

INTERVENTIONS

Diagnostic.

MAIN OUTCOME MEASURES

Postoperative speech perception (AzBio sentence test) scores at 12 months postactivation were compared with repeat testing at 6- to 12-month intervals. Degree of change in impedances from 1 month postactivation was analyzed at similar intervals. Device failures were suspected when impedance levels on three or more electrodes dropped to <3.5 kΩ and AzBio scores declined >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.