HiRes ultra series cochlear implant field recall: failure rates and early outcomes

Winchester, Arianna; Kay‐Rivest, Emily; Friedmann, David R.; McMenomey, Sean O.; Shapiro, William H.; Roland, J. Thomas; Waltzman, Susan B.; Jethanamest, Daniel

doi:10.1080/14670100.2022.2145689

Cited by 6 publications

(10 citation statements)

References 15 publications

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“…Six studies met inclusion criteria. [8][9][10][11][12][13] Characteristics of each of the studies are given in Table 2. A total of 1,319 recalled implants were included across the six studies.…”

Section: Systematic Review Resultsmentioning

confidence: 99%

“…Three studies included pre-and postrevision speech perception scores for adults, including word and sentence testing in quiet and noise. 9,10,12 Consonant-nucleus-consonant in quiet (CNCq) was reported in all three studies and analyzed. Mean CNCq declined with primary implant failure (55.1 to 34.1%) but improved after reimplantation (34.1 to 50.1%) (Fig.…”

Section: Word Recognition Testingmentioning

confidence: 99%

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Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis

Govindan,

Saade,

Perez

et al. 2024

Otol Neurotol

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Objective To compare the rate of device failure for those cochlear implants (CIs) involved in the 2020 Food and Drug Administration (FDA) voluntary field corrective action (VFCA). Databases Reviewed Medline, Embase, and Scopus. Methods A systematic review was performed according to the PRISMA guidelines. Publications reporting institutional experiences with implants affected by the VFCA were included. Outcomes assessed included etiology of, rate of, and time to failure and pre-/post-device failure speech perception testing. All outcomes reported in at least two independent studies were included in a meta-analysis. Results Six studies met criteria for analysis. The overall pooled failure rate was 23.7% (95% CI, 11.6–38.4%). The pooled device, inconclusive, and medical failure rates were 21.5%, 0.2%, and 0.7%, respectively. Pediatric failure rates were higher than those of adults (46.9% [95% CI, 11.2–84.5%] versus 32.6% [95% CI, 8.2–63.7%]). WRS declined with primary implant failure (55.1% [95% CI, 48.0–62.1%] to 34.1% [95% CI, 30.2–38.0%]) but improved after reimplantation (34.1% [95% CI, 30.2–38.0%] to 50.1% [95% CI, 45.2–55.1%]). Conclusions The rate of pooled reported failure for CIs falling under the 2020 VFCA in the literature thus far is 23.7%. The overwhelming majority of these failures were device related, the rates of which were higher in children. Speech perception improved significantly after reimplantation.

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Section: Systematic Review Resultsmentioning

confidence: 99%

Section: Word Recognition Testingmentioning

confidence: 99%

Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis

Govindan,

Saade,

Perez

et al. 2024

Otol Neurotol

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“…Those patients who underwent replacement with Advanced Bionics devices had no additional complications during revision surgery, full electrode insertions were achieved, and, in most cases, speech understanding returned at least to baseline levels. In those patients with a recalled device, 16.8% were noted to require revision surgery for device failure (16). Winchester et al (16) reported a 2.2-year delay between date of original implant and device failure indicating that at-risk devices will continue to emerge as failures over time and the importance of continued surveillance.…”

Section: Discussionmentioning

confidence: 99%

Seven-Year Revision Rates for Cochlear Implants in Pediatric and Adult Populations of an Integrated Healthcare System

Connell,

Chang,

Royse

et al. 2024

Otol Neurotol

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Objective We assessed three cochlear implant (CI) suppliers: Advanced Bionics, Cochlear Limited, and MED-EL, for implant revision requiring reoperation after CI placement. Study Design Retrospective cohort study of integrated-health-system database between 2010 and 2021. Separate models were created for pediatric (age <18) and adult (age ≥18) cohorts. Patients Pediatric (age <18) and adult (age ≥18) patients undergoing cochlear implantation within our integrated healthcare system. Main Outcome Measure Revision after CI placement. Cox proportional hazard regression was used to evaluate revision risk and adjust for confounding factors. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented. Results A total of 2,347 patients underwent a primary CI placement, and Cochlear Limited was most implanted (51.5%), followed by Advanced Bionics (35.2%) and MED-EL (13.3%). In the pediatric cohort, the 7-year crude revision rate was 10.9% for Advanced Bionics and 4.8% for Cochlear Limited, whereas MED-EL had insufficient cases. In adults, the rates were 9.1%, 4.5%, and 3.3% for Advanced Bionics, MED-EL, and Cochlear Limited, respectively. After 2 years of postoperative follow-up, Advanced Bionics had a significantly higher revision risk (HR = 8.25, 95% CI = 2.91–23.46); MED-EL had no difference (HR = 2.07, 95% CI = 0.46–9.25). Conclusion We found an increased revision risk after 2 years of follow-up for adults with Advanced Bionics CI devices. Although we found no statistical difference between manufacturers in the pediatric cohort, after 2 years of follow-up, there were increasing trends in the revision probability for Advanced Bionics. Further research may determine whether patients are better suited for some CI devices.

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“…However, we must consider that while many of these considerations are suitable at the population level, they may not be appropriate for each individual patient. For example, patients with unique device needs, such as those affected by the Advanced Bionics V1 recall, should be followed more closely than the general implant population, as stability of programming and outcomes is less assured [ 38 , 39 ]. Patients with initial poor performance may also not be good candidates for de-escalated programming.…”

Section: Discussionmentioning

confidence: 99%

Preliminary Evidence to Support a De-Escalated Cochlear Implant Programming Paradigm for New Adult Recipients: A Systematic Review

Dornhoffer,

Khandalavala,

Zwolan

et al. 2023

JCM

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Background: No standard schedule for cochlear implant (CI) programming has been developed, and common practices may have CI recipients seen in excess of what is necessary. The objective of this study was to review evidence for a de-escalated, evidence-based schedule for adult CI programming. Methods: Systematic review was undertaken in March 2023 of PubMed, Scopus, and CINAHL databases using the Preferred Reporting Items for Systemic Reviews and Meta-analyses (PRISMA) guidelines. Studies were included if (1) they evaluated an evidence-based programming/follow-up schedule in new adult CI patients or (2) they evaluated programming or outcomes in a longitudinal fashion such that they could inform CI follow-up strategies. Level of evidence was evaluated using the LEGEND evidence assessment tool. Results: Our review identified 940 studies. After screening with a priori inclusion criteria, 18 studies were ultimately included in this review. Of these, 2 demonstrated feasibility of de-escalated approaches to new adult CI programming. The remainder presented longitudinal speech and programming parameter data that demonstrated relative stability of both categories by 3 to 6 months post-activation. Conclusions: Overall, there is a paucity of literature evaluating any form of evidence-based CI programming or follow-up. Most applicable data derive from longitudinal outcomes featured in studies of other CI features, with only a handful of studies directly evaluating CI programming strategies over time. However, stability in outcomes and programming detailed in the available data supports consideration of a de-escalated programming paradigm that could primarily limit programming to the very early post-activation period (before 3 to 6 months) to enhance patient care and reduce operational strains on cochlear implant programs.

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HiRes ultra series cochlear implant field recall: failure rates and early outcomes

Cited by 6 publications

References 15 publications

Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis

Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis

Seven-Year Revision Rates for Cochlear Implants in Pediatric and Adult Populations of an Integrated Healthcare System

Preliminary Evidence to Support a De-Escalated Cochlear Implant Programming Paradigm for New Adult Recipients: A Systematic Review

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