A Protocol for Imaging of Cochlear Implantation.
Ontology highlight
ABSTRACT: Objectives
Correct electrode placement is a challenge of cochlear implant surgery, which occurs because electrode position cannot be directly visualized. This work aims to 1) develop a protocol for a practical, consistent, single view plain radiograph able to be used to confirm cochlear implantation, 2) confirm its usefulness on patients, and 3) confirm its usefulness for identifying misplaced electrodes in cadaveric ears.Study design
Imaging procedure and quality improvement initiative.Setting
Tertiary academic hospital.Patients
Cadaveric ears, and patients undergoing cochlear implantation.Interventions
An intraoperative imaging protocol was developed specifying patient head position, machine position, and exposure setting. This was tested to confirm proper cochlear implantation in patients, including one revision case. This technique allowed the electrode placement to be reliably identified in patients of all ages. Its usefulness for identifying maligned electrodes (partial insertion, and insertion into the vestibule or hypotympanum) was confirmed using four cadaveric hemi-heads.Main outcome measures
Ability to accurately identify correct or incorrect electrode insertion based on radiographic images.Results
After adjusting radiographic exposure to account for the embalming process of the cadaveric heads, this new protocol was confirmed to be able to identify incorrect placement. This was also successfully used to confirm proper placement of cochlear implants in patients.Conclusions
Following a standardized radiographic protocol for cochlear implantation is a quick and easy method for checking electrode position.Supplemental Digital Content, http://links.lww.com/MAO/B253.
SUBMITTER: Wong SJ
PROVIDER: S-EPMC8192428 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Publications
A Protocol for Imaging of Cochlear Implantation.
Wong Stephanie J SJ Strohl-Bryan Alexis M AM Crane Benjamin T BT
Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20210701 6
<h4>Objectives</h4>Correct electrode placement is a challenge of cochlear implant surgery, which occurs because electrode position cannot be directly visualized. This work aims to 1) develop a protocol for a practical, consistent, single view plain radiograph able to be used to confirm cochlear implantation, 2) confirm its usefulness on patients, and 3) confirm its usefulness for identifying misplaced electrodes in cadaveric ears.<h4>Study design</h4>Imaging procedure and quality improvement ini ...[more]
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Project description:ObjectiveTo report a reliable method in obtaining optimal cochlear basal turn and cross-section (c/s) of internal auditory canal (IAC) supporting Cochlear implantation (CI) procedure.Materials and methodsComputer tomography (CT) and magnetic resonance image (MRI) scans of potential CI candidates from 2018 to 2022 from the tertiary center were considered for analysis. Slicer software was used in three-dimensional (3D) segmentation of inner ear and for capturing the cochlear basal turn.ResultsA total of 1932 head scans were made available for the analysis and out of which 1866 scans had normal anatomy (NA) inner ear. Incomplete partition (IP) type-I was identified in 19 ears, IP type-II in 27 ears, IP type-III in 6 ears, cochlear hypoplasia (CH) type-I in 6 ears, CH type-II in 1 ear, CH type-III in 3 ears, and CH type-IV is 3 ears, and enlarged vestibular aqueduct syndrome in 1 ear. 3D segmented inner ear helped in successfully obtaining the cochlear basal turn and the c/s of IAC in all anatomical types. Time taken to capture the cochlear basal turn with the help of 3D segmented inner ear was <1 min. Within the NA category, five cases showed scalar ossification, and its extent was identified in the cochlear basal turn.ConclusionThe identification and the extent of ossification in the scala tympani, shape of the basal turn, and the cochlear size measurement in cochlear basal turn has high clinical relevance as this helps in surgical planning and in choosing appropriate electrode length. Level of evidence: Level 2 to the best of our understanding.
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Project description:BackgroundIn order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a "straight" lateral wall lying electrode array (LW) or a "pre-curved" perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options.MethodsWe designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).DiscussionCochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation.Trial registrationNetherlands Trial Register (NTR) NL8586 . Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.
| S-EPMC8656003 | biostudies-literature
Project description:Background and Objectives: Many otologists face a dilemma in the decision-making process of surgical management of patients with cochlear nerve (CN) aplasia. The goal of this study is to provide fresh evidence on cochlear implantation (CI) results in patients with CN aplasia. Materials and Methods: We scrutinized functional outcomes in 37 ears of 21 children with bilateral CN aplasia who underwent unilateral or bilateral CI based on cross-sectional and longitudinal assessments. Results: The Categories of Auditory Performance (CAP) scores gradually improved throughout the 3-year follow-up; however, variable outcomes existed between individuals. Specifically, 90% of recipients with a 1-year postoperative CAP score ≤1 could not achieve a CAP score over 1 even at 3-year postoperative evaluation, while the recipients with a 1-year postoperative CAP score >1 had improved auditory performance, and 72.7% of them were able to achieve a CAP score of 4 or higher. Meanwhile, intraoperative electrically evoked compound action potential was not correlated with postoperative CAP score. Conclusions: Our results further refine previous studies on the clinical feasibility of CI as the first treatment modality to elicit favorable auditory performance in children with CN aplasia. However, special attention should be paid to pediatric patients with an early postoperative CAP score ≤1 for identification of unsuccessful cochlear implants and switching to auditory brainstem implants.
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Project description:IntroductionTinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.Method and analysisIn this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck's Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.Ethics and disseminationThis research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.Trial registration numberTrial registration number NL8693; Pre-results.
| S-EPMC8130732 | biostudies-literature
Project description:Cochlear implantation has become the standard-of-care for adults and children with severe to profound hearing loss. There is growing evidence that qualitative as well as quantitative deficits in the auditory nerve may affect cochlear implant (CI) outcomes. Auditory neuropathy spectrum disorder (ANSD) is characterized by dysfunctional transmission of sound from the cochlea to the brain due to defective synaptic function or neural conduction. In this review, we examine the precise mechanisms of genetic lesions causing ANSD and the effect of these lesions on CI outcomes. Reviewed data show that individuals with lesions that primarily affect the cochlear sensory system and the synapse, which are bypassed by the CI, have optimal CI outcomes. Individuals with lesions that affect the auditory nerve show poor performance with CIs, likely because neural transmission of the electrical signal from the CI is affected. We put forth a nuanced molecular classification of ANSD that has implications for preoperative counseling for patients with this disorder prior to cochlear implantation. We propose that description of ANSD patients should be based on the molecular site of lesion typically derived from genetic evaluation (synaptopathy vs. neuropathy) as this has implications for expected CI outcomes. Improvements in our understanding of genetic site of lesions and their effects on CI function should lead to better CI outcomes, not just for individuals with auditory neuropathy, but all individuals with hearing loss.
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Project description:BackgroundSensorineural hearing loss occurs as a result of damage to the hair cells in the cochlea, or to the auditory nerve. It negatively affects learning and development in children, and employment and economic attainment in adults. Current policy in Ontario is to provide unilateral cochlear implantation for patients with bilateral severe to profound sensorineural hearing loss. However, hearing with both ears as a result of bilateral cochlear implantation may offer added benefits.MethodsWe completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, budget impact, and patient preferences related to bilateral cochlear implantation. We performed a systematic literature search for studies on bilateral cochlear implantation in adults and children from inception to March 2017. We conducted a cost-utility analysis with a lifetime horizon from a public payer perspective and analyzed the budget impact of publicly funding bilateral cochlear implantation in adults and children in Ontario for the next 5 years. Finally, we conducted interviews with adults who have sensorineural hearing loss and unilateral or bilateral cochlear implants, and with parents of children with bilateral cochlear implants.ResultsWe included 24 publications (10 in adults, 14 in children) in the clinical evidence review. Compared with unilateral cochlear implantation, bilateral cochlear implantation improved sound localization, speech perception in noise, and subjective benefits of hearing in adults and children with severe to profound sensorineural hearing loss (GRADE: moderate to high). Bilateral cochlear implantation also allowed for better language development and more vocalization in preverbal communication in children (GRADE: moderate). The safety profile was acceptable.Bilateral cochlear implantation was more expensive and more effective than unilateral cochlear implantation. The incremental cost-effectiveness ratio was $48,978/QALY in adults and between $27,427/QALY and $30,386/QALY in children. Cost-effectiveness was highly dependent on the quality-of-life values used. We estimated that the net budget impact of publicly funding bilateral cochlear implantation for adults in Ontario would be between $510,000 and $780,000 per year for the next 5 years.Patients described the social and emotional effects of hearing loss, and the benefits and challenges of using cochlear implants.ConclusionsBased on evidence of moderate to high quality, we found that bilateral cochlear implantation improved hearing in adults and children with severe to profound sensorineural hearing loss. Bilateral cochlear implantation was potentially cost-effective compared to unilateral cochlear implantation in adults and children. Patients with sensorineural hearing loss reported the positive effects of cochlear implants, and patients with unilateral cochlear implants generally expressed a desire for bilateral implants.
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Project description:BackgroundUntreated hearing loss has an effect on cognition. It is hypothesized that the additional processing required to compensate for the sensory loss affects the cognitive resources available for other tasks and that this could be mitigated by a hearing device.MethodsThe impact on cognition of cochlear implants (CIs) was tested in 100 subjects, ≥60 years old, with bilateral moderately-severe to profound post linguistic deafness using hearing aids. Data was compared pre and 12 and 18 months after cochlear implantation for the speech spatial qualities questionnaire, Mini Mental State Examination (MMSE), Trail making test B (TMTB) and digit symbol coding (DSC) from the Wechsler Adult Intelligence Scale version IV and finally the timed up and go test (TUG). Subjects were divided into young old (60-64), middle old (65-75) and old old (75+) groups. Cognitive test scores and times were standardized according to available normative data.ResultsHearing significantly improved pre- to post-operatively across all age groups. There was no change post-implant in outcomes for TMTB, TUG or MMSE tests. Age-corrected values were within normal expectations for all age groups for the TUG and MMSE. However, DSC scores and TMTB times were worse than normal. There was a significant increase in DSC scores between baseline and 12-months for 60- to 64-year-olds (t[153] = 2.608, p = 0.027), which remained at 18 months (t[153] = 2.663, p = 0.023).DiscussionThe improved attention and processing speed in the youngest age group may be a consequence of reallocation of cognitive resources away from auditory processing due to greatly improved hearing. The oldest age group of participants had cognition scores closest to normal values, suggesting that only the most able older seniors tend to come forward for a CI. Severe to profoundly deaf individuals with hearing aids or cochlear implants were still poorer than age-equivalent normally hearing individuals with respect to cognitive flexibility, attention, working memory, processing speed and visuoperceptual functions. Due to a lack of data for the TUG, TMTB and DSC in the literature for hearing impaired individuals, the results reported here provide an important set of reference data for use in future research.
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Project description:Cochlear implantation (CI) has become the mainstay of treatment for children with severe-to-profound sensorineural hearing loss (SNHL). Yet, despite mounting evidence of the clinical benefits of early implantation, little data are available on the long-term societal benefits and comparative effectiveness of this procedure across various ages of implantation-a choice parameter for parents and clinicians with high prognostic value for clinical outcome. As such, the aim of the present study is to evaluate a model of the consequences of the timing of this intervention from a societal economic perspective. Average cost utility of pediatric CI by age at intervention will be analyzed.Prospective, longitudinal assessment of health utility and educational placement outcomes in 175 children recruited from six U.S. centers between November 2002 and December 2004, who had severe-to-profound SNHL onset within 1 year of age, underwent CI before 5 years of age, and had up to 6 years of postimplant follow-up that ended in November 2008 to December 2011. Costs of care were collected retrospectively and stratified by preoperative, operative, and postoperative expenditures. Incremental costs and benefits of implantation were compared among the three age groups and relative to a nonimplantation baseline.Children implanted at <18 months of age gained an average of 10.7 quality-adjusted life years (QALYs) over their projected lifetime as compared with 9.0 and 8.4 QALYs for those implanted between 18 and 36 months and at >36 months of age, respectively. Medical and surgical complication rates were not significantly different among the three age groups. In addition, mean lifetime costs of implantation were similar among the three groups, at approximately $2000/child/year (77.5-year life expectancy), yielding costs of $14,996, $17,849, and $19,173 per QALY for the youngest, middle, and oldest implant age groups, respectively. Full mainstream classroom integration rate was significantly higher in the youngest group at 81% as compared with 57 and 63% for the middle and oldest groups, respectively (p < 0.05) after 6 years of follow-up. After incorporating lifetime educational cost savings, CI led to net societal savings of $31,252, $10,217, and $6,680 for the youngest, middle, and oldest groups at CI, respectively, over the child's projected lifetime.Even without considering improvements in lifetime earnings, the overall cost-utility results indicate highly favorable ratios. Early (<18 months) intervention with CI was associated with greater and longer quality-of-life improvements, similar direct costs of implantation, and economically valuable improved classroom placement, without a greater incidence of medical and surgical complications when compared to CI at older ages.
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Project description:Cochlear implantation is a surgical alternative to traditional amplification (hearing aids) that can facilitate spoken language development in young children with severe to profound sensorineural hearing loss (SNHL).To prospectively assess spoken language acquisition following cochlear implantation in young children.Prospective, longitudinal, and multidimensional assessment of spoken language development over a 3-year period in children who underwent cochlear implantation before 5 years of age (n = 188) from 6 US centers and hearing children of similar ages (n = 97) from 2 preschools recruited between November 2002 and December 2004. Follow-up completed between November 2005 and May 2008.Performance on measures of spoken language comprehension and expression (Reynell Developmental Language Scales).Children undergoing cochlear implantation showed greater improvement in spoken language performance (10.4; 95% confidence interval [CI], 9.6-11.2 points per year in comprehension; 8.4; 95% CI, 7.8-9.0 in expression) than would be predicted by their preimplantation baseline scores (5.4; 95% CI, 4.1-6.7, comprehension; 5.8; 95% CI, 4.6-7.0, expression), although mean scores were not restored to age-appropriate levels after 3 years. Younger age at cochlear implantation was associated with significantly steeper rate increases in comprehension (1.1; 95% CI, 0.5-1.7 points per year younger) and expression (1.0; 95% CI, 0.6-1.5 points per year younger). Similarly, each 1-year shorter history of hearing deficit was associated with steeper rate increases in comprehension (0.8; 95% CI, 0.2-1.2 points per year shorter) and expression (0.6; 95% CI, 0.2-1.0 points per year shorter). In multivariable analyses, greater residual hearing prior to cochlear implantation, higher ratings of parent-child interactions, and higher socioeconomic status were associated with greater rates of improvement in comprehension and expression.The use of cochlear implants in young children was associated with better spoken language learning than would be predicted from their preimplantation scores.
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Project description:To analyse the benefit of cochlear implantation in young deaf children with Waardenburg syndrome (WS) compared to a reference group of young deaf children without additional disabilities.A retrospective study was conducted on children with WS who underwent cochlear implantation at the age of 2 years or younger. The post-operative results for speech perception (phonetically balanced standard Dutch consonant-vocal-consonant word lists) and language comprehension (the Reynell Developmental Language Scales, RDLS), expressed as a language quotient (LQ), were compared between the WS group and the reference group by using multiple linear regression analysis.A total of 14 children were diagnosed with WS, and 6 of them had additional disabilities. The WS children were implanted at a mean age of 1.6 years and the 48 children of the reference group at a mean age of 1.3 years. The WS children had a mean phoneme score of 80% and a mean LQ of 0.74 at 3 years post-implantation, and these results were comparable to those of the reference group. Only the factor additional disabilities had a significant negative influence on auditory perception and language comprehension.Children with WS performed similarly to the reference group in the present study, and these outcomes are in line with the previous literature. Although good counselling about additional disabilities concomitant to the syndrome is relevant, cochlear implantation is a good rehabilitation method for children with WS.
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