Failure in HiRes Ultra Series Recall Devices Does Not Necessarily Lead to Decrement in Performance.

ABSTRACT

OBJECTIVE: To understand the impact on speech perception for patients experiencing Advanced Bionics V1 series Ultra and Ultra 3D cochlear implant failure. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic center. PATIENTS Adult patients implanted with V1 series devices. INTERVENTIONS: Device integrity and speech perception testing. MAIN OUTCOME MEASURES: consonant-nucleus-consonant and AzBio in quiet speech recognition scores. RESULTS: At our institution, 116 V1 series cochlear implants were placed in 114 patients. Thirteen devices in prelingual patients were excluded, leaving 103 (89%) for final analysis. Forty-eight (46.6%) devices were considered as failed using the company provided EFI analysis tool. There were 36 (65.5%) of the remaining 55 devices that consistently tested within normal range; the remainder lost to follow-up with unknown status. Among the 48 device failures, 29 were revised and 19 patients were not revised. Among those not revised, 11 self-opted for observation (57.9%). Observed patients, despite impedance changes meeting failure criteria, had no subjective or objective changes in speech perception. Sentence testing scores for failure patients who elected observation (82.9 ± 11.4%) were significantly higher at failure compared with those opting for revision (55 ± 22.8%, p = 0.006). For those undergoing revision surgery, significant improvement in post-activation scores was noted as compared with time of failure with a mean improvement of 12.9% (p = 0.002, n = 24) for consonant-nucleus-consonant word scores and 17.2% (p = 0.001, n = 19) for AzBio in quiet scores. CONCLUSIONS: Proactive monitoring using EFI identifies a higher rate of Ultra Series V1 device failure than previously reported. However, about 20% of these patients may not have subjective change in hearing or objective decline in test scores and could be observed. Should performance worsen, reimplantation provides significant improvement in speech recognition.