A Multi-Institutional Analysis of Device Failures in a Recent Cochlear Implant Series.

IF 1.9 3区医学 Q3 CLINICAL NEUROLOGY

Otology & Neurotology Pub Date : 2025-08-01 Epub Date: 2025-02-25 DOI:10.1097/MAO.0000000000004438

Michael H Freeman, Nathan R Lindquist, James R Dornhoffer, Kristen L Yancey, Ankita Patro, Benjamin D Lovin, Taimur Siddiqui, Aniket A Saoji, Jourdan R Holder, Walter Kutz, Alex D Sweeney, David S Haynes, Matthew L Carlson, Marc L Bennett

{"title":"A Multi-Institutional Analysis of Device Failures in a Recent Cochlear Implant Series.","authors":"Michael H Freeman, Nathan R Lindquist, James R Dornhoffer, Kristen L Yancey, Ankita Patro, Benjamin D Lovin, Taimur Siddiqui, Aniket A Saoji, Jourdan R Holder, Walter Kutz, Alex D Sweeney, David S Haynes, Matthew L Carlson, Marc L Bennett","doi":"10.1097/MAO.0000000000004438","DOIUrl":null,"url":null,"abstract":"Objective: To assess Advanced Bionics (AB) HiRes Ultra and Ultra 3D initial version (V1) cochlear implant electrode failures over time at four large cochlear implant programs.Study design: Retrospective cohort.Setting: Four tertiary referral centers.Patients: Patients receiving AB HiRes Ultra and Ultra 3D initial version (V1) devices as of December 31, 2022.Main outcome measures: Failure rate, revision surgery, speech recognition scores.Results: Over a span of 7 years, 205 (42.6%) of 483 implanted V1 devices have failed. Device failure rate varied across institutions from 32 to 67%. Of the 205 detected failures, 163 (79%) have undergone revision surgery, with 94% of revisions being performed with Advanced Bionics devices. Average time from implantation to diagnosis of device failure was 2.7 ± 1.2 years. Most patients (89.8%) with available testing were matched or exceeded their best prefailure speech performance after implant revision. After revision, patients had an average CNC score improvement of 24.7 percentage points over their most recent pre-revision scores and demonstrated average datalogging of 12.7 ± 4.1 h/d at most recent evaluation.Conclusions: Comparison of patients across multiple high-volume implant centers confirms the presence of ongoing device failures. There is variability across institutions in the rate of revision surgery once a patient is diagnosed with a V1 device failure, as well as in the rate of device failure detection. Inter-institutional variability in failure rates may be explained by the variation in the routine use of electrical field imaging. Reimplantation with a new device typically results in a return to prefailure peak performance.Professional practice gap educational need: To our knowledge, a comparison of AB HiRes (V1) device failures across multiple institutions has not been conducted.Learning objective: To identify device failure rate across multiple institutions with different testing protocols.Desired result: Providers will have an improved understanding of the trajectory of device failures for HiRes (V1) devices over time.Level of evidence: Level IV-Historical cohort or case-controlled studies.Indicate irb or iacuc: IRB #230017; IRB #22-000183; IRB #STU-032018-085; IRB #H-49479.","PeriodicalId":19732,"journal":{"name":"Otology & Neurotology","volume":" ","pages":"789-795"},"PeriodicalIF":1.9000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Otology & Neurotology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MAO.0000000000004438","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/25 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: To assess Advanced Bionics (AB) HiRes Ultra and Ultra 3D initial version (V1) cochlear implant electrode failures over time at four large cochlear implant programs.

Study design: Retrospective cohort.

Setting: Four tertiary referral centers.

Patients: Patients receiving AB HiRes Ultra and Ultra 3D initial version (V1) devices as of December 31, 2022.

Main outcome measures: Failure rate, revision surgery, speech recognition scores.

Results: Over a span of 7 years, 205 (42.6%) of 483 implanted V1 devices have failed. Device failure rate varied across institutions from 32 to 67%. Of the 205 detected failures, 163 (79%) have undergone revision surgery, with 94% of revisions being performed with Advanced Bionics devices. Average time from implantation to diagnosis of device failure was 2.7 ± 1.2 years. Most patients (89.8%) with available testing were matched or exceeded their best prefailure speech performance after implant revision. After revision, patients had an average CNC score improvement of 24.7 percentage points over their most recent pre-revision scores and demonstrated average datalogging of 12.7 ± 4.1 h/d at most recent evaluation.

Conclusions: Comparison of patients across multiple high-volume implant centers confirms the presence of ongoing device failures. There is variability across institutions in the rate of revision surgery once a patient is diagnosed with a V1 device failure, as well as in the rate of device failure detection. Inter-institutional variability in failure rates may be explained by the variation in the routine use of electrical field imaging. Reimplantation with a new device typically results in a return to prefailure peak performance.

Professional practice gap educational need: To our knowledge, a comparison of AB HiRes (V1) device failures across multiple institutions has not been conducted.

Learning objective: To identify device failure rate across multiple institutions with different testing protocols.

Desired result: Providers will have an improved understanding of the trajectory of device failures for HiRes (V1) devices over time.

Level of evidence: Level IV-Historical cohort or case-controlled studies.

Indicate irb or iacuc: IRB #230017; IRB #22-000183; IRB #STU-032018-085; IRB #H-49479.

查看原文本刊更多论文

近期人工耳蜗植入系列中设备失效的多机构分析。

目的：评估Advanced Bionics (AB) HiRes Ultra和Ultra 3D initial version （V1）人工耳蜗电极在四个大型人工耳蜗项目中随时间的失效情况。研究设计：回顾性队列。环境：四个三级转诊中心。患者：截至2022年12月31日，接受AB HiRes Ultra和Ultra 3D初始版本（V1）设备的患者。主要观察指标：失败率、翻修手术、语音识别评分。结果：在7年的时间里，483个V1装置植入205个（42.6%）失败。不同机构的设备故障率从32%到67%不等。在检测到的205例故障中，163例（79%）进行了修复手术，其中94%的修复使用了先进的仿生学设备。从植入到诊断器械故障的平均时间为2.7±1.2年。大多数患者（89.8%）在种植体修复后的可用测试达到或超过了他们在失败前的最佳语言表现。在翻修后，患者的平均CNC评分比他们最近翻修前的评分提高了24.7个百分点，并且在最近的评估中显示平均数据记录为12.7±4.1 h/d。结论：对多个大容量植入中心的患者进行比较，证实存在持续的设备故障。一旦患者被诊断为V1装置故障，各机构的翻修手术率以及装置故障检测率都存在差异。机构间失败率的差异可以通过电场成像的常规使用的差异来解释。用新设备重新安装通常会导致恢复到故障前的峰值性能。专业实践差距教育需求：据我们所知，尚未对多个机构的AB HiRes （V1）设备故障进行比较。学习目标：确定不同测试方案的多个机构的设备故障率。期望结果：随着时间的推移，供应商将更好地了解hire （V1）设备的设备故障轨迹。证据等级：iv级——历史队列或病例对照研究。指示irb或iacuc: irb# 230017；IRB # 22 - 000183;IRB #斯图- 032018 - 085;IRB # h - 49479。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Otology & Neurotology 医学-耳鼻喉科学

CiteScore

3.80

自引率

14.30%

发文量

509

审稿时长

3-6 weeks

期刊介绍： Otology & Neurotology publishes original articles relating to both clinical and basic science aspects of otology, neurotology, and cranial base surgery. As the foremost journal in its field, it has become the favored place for publishing the best of new science relating to the human ear and its diseases. The broadly international character of its contributing authors, editorial board, and readership provides the Journal its decidedly global perspective.