HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition Outcomes.
HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition Outcomes.
复制标题
雇用Ultra系列召回：失败率和修订语音识别结果。
DOI：
10.1097/mao.0000000000003598
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发表时间：
2022-08-01
影响因子：
2.1
通讯作者：
Holder, Jourdan T.
中科院分区：
文献类型：
--
作者：
Lindquist, Nathan R.;Cass, Nathan D.;Patro, Ankita;Perkins, Elizabeth L.;Gifford, Rene H.;Haynes, David S.;Holder, Jourdan T.
报告高级仿生学(AB)、超(V1)和超3D(V1)人工耳蜗(CI)电极故障和大型CI计划患者的修订语音识别结果。回顾病例系列。第三转诊中心。截至2021年9月21日接受超(V1)或超3D(V1)设备治疗的患者。失败率，翻修手术，语音识别分数。根据数据，在308个植入的装置中，65个(21.1%)是已知的故障，其中63个(20.5%)与最近的自愿现场纠正行动(FCA)有关。平均失败时间为2.2±1.1年。52名患者(82.5%)选择了翻修手术。在成人中，即刻修订前的分数与有缺陷的植入物的最佳成绩相比有显著的下降，在安静的情况下，cnc的平均差值为−15.2%(p=0.0115)，Azbio的平均差值为27.3%(p<；0.0001)。在修订后的设备激活3个月后，在安静状态下的计算机控制(p=0.9766)和azbio(p=0.9501)的分数与修订前的最佳分数没有显著差异。总体而言，19名患者中有15名恢复或改善了翻修前的最佳数控评分。目前FCA设备故障的轨迹约为每年6%。与制造商报告相比，大量患者经历了Ultra(V1)和Ultra 3D(V1)设备的硬故障。早期识别故障可能是由于勤奋地使用电场成像(EFI)测试。大多数受FCA影响的患者在翻修手术后3个月内就恢复或超过了失败前的语音识别分数。
To report Advanced Bionics (AB) Ultra (V1) and Ultra 3D (V1) cochlear implant (CI) electrode failures and revision speech recognition outcomes for patients at a large CI program. Retrospective case series. Tertiary referral center. Patients receiving Ultra (V1) or Ultra 3D (V1) devices as of September 21, 2021. Failure rate, revision surgery, speech recognition scores. To data, 65 (21.1%) of the 308 implanted devices are known failures, with 63 (20.5%) associated with the recent voluntary field corrective action (FCA). Average time to failure was 2.2 ± 1.1 years. Fifty-two patients (82.5%) elected for revision surgery. Among adults, immediate pre-revision scores demonstrated a significant decrease from best-achieved scores with the faulty implant, with mean difference of −15.2% (p=0.0115) for CNC and −27.3% (p<0.0001) for AzBio in quiet. By 3 months post-activation of the revised device, CNC (p=0.9766) and AzBio in quiet (p=0.9501) scores were not significantly different than best pre-revision scores. Overall, 15 of 19 patients regained or improved their best pre-revision CNC score. The current trajectory for FCA device failures is approximately 6% per year. Compared to manufacturer reporting, a high number of patients experienced hard failures of the Ultra (V1) and Ultra 3D (V1) devices. Early identification of failures is possibly due to diligent use of electrical field imaging (EFI) testing. Most patients affected by the FCA regain or exceed their pre-failure speech recognition score as soon as 3 months after revision surgery.