Trends in Cochlear Implant Complications

Causon, Andrew; Verschuur, Carl; Newman, Tracey A.

doi:10.1097/mao.0b013e31827d0943

Cited by 32 publications

(15 citation statements)

References 20 publications

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“…This includes instances of device‐ and patient‐related complications. This database has been used to examine a range of devices, such as sinus balloons, cochlear implants, bone‐anchored hearing aids, and robot‐assisted surgical systems 17–20 . The search term “sinus navigation” was used to identify medical device reports made between January 1, 2018, and January 1, 2022, for FDA‐approved navigation systems used for ESS.…”

Section: Methodsmentioning

confidence: 99%

Adverse Events Associated With Image‐Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis

Orozco

Ulloa

Lin

et al. 2022

Otolaryngol.--head neck surg.

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Objective The utilization of image-guided navigation during endoscopic sinus surgery (ESS) has increased significantly since its introduction. However, the most common associated complications are still unknown. This study describes and analyzes adverse events related to image-guided ESS. Study Design Cross-sectional analysis. Setting The Food and Drug Administration’s 2018-2022 MAUDE database (Manufacturer and User Facility Device Experience). Methods The MAUDE database was searched for all reports on adverse events involving sinus navigation systems used in ESS from 2018 to 2022. Reported events were reviewed and categorized. Results During the study period, there were 1857 adverse events from 1565 reports, which were divided into device-related (n = 1834, 98.8%) and patient-related (n = 23, 1.2%) complications. The most common device-related complications were nonfunctionality of the system (n = 512, 27.9%), device imprecision (n = 427, 23.3%), and device sensing problems (n = 277, 15.1%). The most common patient-related complications were cerebrospinal fluid (CSF) leak (n = 14, 60.9%), intracranial injury (n = 4, 17.4%), and bleeding/hemorrhage (n = 3, 13.1%). Imprecision was associated with increased risk of navigation abortion by the surgeon (odds ratio, 1.50 [95% CI, 1.38-1.65]; P < .001) and increased risk of CSF leak (odds ratio, 16.5 [95% CI, 3.66-74.0]; P < .001) as compared with other device-related complications. Conclusions The most commonly reported device- and patient-related adverse events associated with image-guided sinus navigation systems were device nonfunction, imprecision, device sensing difficulties, and CSF leak. When imprecise navigation occurred, there was an increased likelihood of CSF leak and navigation abortion by the surgeon. Health care providers should be mindful of these possible complications when electing to use image-guided sinus navigation during ESS.

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Section: Methodsmentioning

confidence: 99%

Adverse Events Associated With Image‐Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis

Orozco

Ulloa

Lin

et al. 2022

Otolaryngol.--head neck surg.

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“…For those undergoing bilateral implant surgery (which includes the majority of children receiving a CI in the United Kingdom), this can mean complete loss of auditory stimulation for a period of up to a month between CI surgery and initial device tuning. Another group that have a period of no or limited access to auditory stimulation are the 1–2% of CI users per year that experience device failure ( Causon et al, 2013 ). These individuals typically face a wait of many months between the failure occurring and switch-on of a re-implanted device.…”

Section: Electro-haptic Stimulationmentioning

confidence: 99%

Electro-Haptic Stimulation: A New Approach for Improving Cochlear-Implant Listening

Fletcher

Verschuur

2021

Front. Neurosci.

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Cochlear implants (CIs) have been remarkably successful at restoring speech perception for severely to profoundly deaf individuals. Despite their success, several limitations remain, particularly in CI users’ ability to understand speech in noisy environments, locate sound sources, and enjoy music. A new multimodal approach has been proposed that uses haptic stimulation to provide sound information that is poorly transmitted by the implant. This augmenting of the electrical CI signal with haptic stimulation (electro-haptic stimulation; EHS) has been shown to improve speech-in-noise performance and sound localization in CI users. There is also evidence that it could enhance music perception. We review the evidence of EHS enhancement of CI listening and discuss key areas where further research is required. These include understanding the neural basis of EHS enhancement, understanding the effectiveness of EHS across different clinical populations, and the optimization of signal-processing strategies. We also discuss the significant potential for a new generation of haptic neuroprosthetic devices to aid those who cannot access hearing-assistive technology, either because of biomedical or healthcare-access issues. While significant further research and development is required, we conclude that EHS represents a promising new approach that could, in the near future, offer a non-invasive, inexpensive means of substantially improving clinical outcomes for hearing-impaired individuals.

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“…Since the widespread introduction of CIs in the 1980s, there have been several refinements to the technology and related health policy. Improvements in hardware manufacture, signal processing strategies, surgical techniques and the relaxation of CI candidacy criteria have all contributed to better clinical outcomes, including preservation of residual hearing (Nguyen et al, 2016), improved speech recognition (Wilson and Dorman, 2008) and fewer device related adverse events (Causon et al, 2013). Despite these improvements, however, some users still experience poor or declining speech recognition, poor sound quality and stimulation of non-auditory sensations.…”

Section: Introductionmentioning

confidence: 99%

“…The explanted device is tested, and if hardware failure and surgical complications are excluded, a “soft failure” is diagnosed (Balkany et al, 2005). As hardware has improved, these soft failures, or idiopathic cases, have become relatively more common (Causon et al, 2013), and research is clearly needed to better understand how individual biology, and in particular the immune system, interacts with the neuroprosthesis to drive these adverse events. Conventional counts of soft failures only record those devices which perform badly enough to need surgical removal and not those that underperform, and so will necessarily under-estimate the influence of these biological factors.…”

Section: Introductionmentioning

confidence: 99%

Exploiting Routine Clinical Measures to Inform Strategies for Better Hearing Performance in Cochlear Implant Users

et al. 2019

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Neuroprostheses designed to interface with the nervous system to replace injured or missing senses can significantly improve a patient’s quality of life. The challenge remains to provide implants that operate optimally over several decades. Changes in the implant-tissue interface may precede performance problems. Tools to identify and characterize such changes using existing clinical measures would be highly valuable. Modern cochlear implant (CI) systems allow easy and regular measurements of electrode impedance (EI). This measure is routinely performed as a hardware integrity test, but it also allows a level of insight into the immune-mediated response to the implant, which is associated with performance outcomes. This study is a 5-year retrospective investigation of MED-EL CI users at the University of Southampton Auditory Implant Service including 176 adult ears (18–91) and 74 pediatric ears (1–17). The trend in EI in adults showed a decrease at apical electrodes. An increase was seen at the basal electrodes which are closest to the surgery site. The trend in the pediatric cohort was increasing EI over time for nearly all electrode positions, although this group showed greater variability and had a smaller sample size. We applied an outlier-labeling rule to statistically identify individuals that exhibit raised impedance. This highlighted 14 adult ears (8%) and 3 pediatric ears (5%) with impedance levels that deviated from the group distribution. The slow development of EI suggests intra-cochlear fibrosis and/or osteogenesis as the underlying mechanism. The usual clinical intervention for extreme impedance readings is to deactivate the relevant electrode. Our findings highlight some interesting clinical contradictions: some cases with raised (but not extreme) impedance had not prompted an electrode deactivation; and many cases of electrode deactivation had been informed by subjective patient reports. This emphasizes the need for improved objective evidence to inform electrode deactivations in borderline cases, for which our outlier-labeling approach is a promising candidate. A data extraction and analysis protocol that allows ongoing and automated statistical analysis of routinely collected data could benefit both the CI and wider neuroprosthetics communities. Our approach provides new tools to inform practice and to improve the function and longevity of neuroprosthetic devices.

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Trends in Cochlear Implant Complications

Abstract: Findings suggest that there is an urgent need to undertake further research to investigate causes for idiopathic and gradual CI adverse events to continue the overall improvement in CI outcomes.

Cited by 32 publications

References 20 publications

Adverse Events Associated With Image‐Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis

Adverse Events Associated With Image‐Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis

Electro-Haptic Stimulation: A New Approach for Improving Cochlear-Implant Listening

Exploiting Routine Clinical Measures to Inform Strategies for Better Hearing Performance in Cochlear Implant Users

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