Holistic assessment of cochlear implant outcomes using the international classification of functioning disability and health model: data analysis of a longitudinal prospective multicenter study.

PURPOSE: To study outcome after cochlear implantation using the Cochlear Implant (CI) outcome assessment protocol based on the International Classification of Functioning, Disability and Health (ICF) model (CI-ICF). METHODS: Raw data of a prospective, longitudinal, multicenter study was analyzed. Seventy-two CI candidates were assessed preoperatively and six months postoperatively using the CI-ICF protocol. Following tools were used: (1) Work Rehabilitation Questionnaire (WORQ), (2) Abbreviated Profile of Hearing Aid Benefit (APHAB), (3) Audio Processor Satisfaction Questionnaire (APSQ), (4) Speech, Spatial, and Qualities of Hearing Scale (SSQ12), (5) Hearing Implant Sound Quality Index (HISQUI19), (6) Nijmegen CI Questionnaire (NCIQ) (7) pure tone audiometry, (8) speech audiometry, (9) sound localization. RESULTS: There was a significant improvement of speech discrimination in quiet (p = 0.015; p < 0.001) and in noise (p = 0.041; p < 0.001), sound detection (p < 0.001), tinnitus (p = 0.026), listening (p < 0.001), communicating with-receiving-spoken messages (p < 0.001), conversation (p < 0.001), family relationships (p < 0.001), community life (p = 0.019), NCIQ total score and all subdomain scores (p < 0.001). Subjective sound localization significantly improved (p < 0.001), while psychometric sound localization did not. There was no significant subjective deterioration of vestibular functioning and no substantial change in sound aversiveness. CI users reported a high level of implant satisfaction postoperatively. CONCLUSION: This study highlights the positive impact of cochlear implantation on auditory performance, communication, and subjective well-being. The CI-ICF protocol provides a holistic and comprehensive view of the evolution of CI outcomes.

Electrically evoked compound action potentials are associated with the site of intracochlear stimulation.

OBJECTIVES: Objective measurements to predict the position of a cochlear electrode during cochlear implantation surgery may serve to improve the surgical technique and postoperative speech outcome. There is evidence that electrically evoked compound action potentials (ECAP) are a suitable approach to provide information about the site of stimulation. This study aims to contribute to the knowledge about the association between the intraoperative intracochlear ECAP characteristics and the site of stimulation. METHODS: In a retrospective cohort study, patients undergoing cochlear implant surgery with flexible lateral wall electrode arrays (12 stimulating channels) between 2020 and 2022 were analyzed. The CDL was measured using a CT-based clinical planning software. ECAP were measured for all electrode contacts and associated to the CDL as well as to the site of stimulation in degree. RESULTS: Significant differences among the amplitudes and slopes for the individual stimulated electrode contacts at the stimulation sites of 90°, 180°, 270°, 360°, 450° and 540° were found. The values showed a trend for linearity among the single electrodes. CONCLUSIONS: ECAP characteristics correlate with the electrode's position inside the cochlea. In the future, ECAP may be applied to assess the intracochlear position inside the cochlea and support anatomy-based fitting.

Comparing linear and non-linear models to estimate the appropriate cochlear implant electrode array length-are current methods precise enough?

PURPOSE: In cochlear implantation with flexible lateral wall electrode arrays, a cochlear coverage (CC) range between 70% and 80% is considered ideal for optimal speech perception. To achieve this CC, the cochlear implant (CI) electrode array has to be chosen according to the individual cochlear duct length (CDL). Here, we mathematically analyzed the suitability of different flexible lateral wall electrode array lengths covering between 70% and 80% of the CDL. METHODS: In a retrospective cross-sectional study preoperative high-resolution computed tomography (HRCT) from patients undergoing cochlear implantation was investigated. The CDL was estimated using an otosurgical planning software and the CI electrode array lengths covering 70-80% of the CDL was calculated using (i) linear and (ii) non-linear models. RESULTS: The analysis of 120 HRCT data sets showed significantly different model-dependent CDL. Significant differences between the CC of 70% assessed from linear and non-linear models (mean difference: 2.5 mm, p < 0.001) and the CC of 80% assessed from linear and non-linear models (mean difference: 1.5 mm, p < 0.001) were found. In up to 25% of the patients none of the existing flexible lateral wall electrode arrays fit into this range. In 59 cases (49,2%) the models did not agree on the suitable electrode arrays. CONCLUSIONS: The CC varies depending on the underlying CDL approximation, which critically influences electrode array choice. Based on the literature, we hypothesize that the non-linear method systematically overestimates the CC and may lead to rather too short electrode array choices. Future studies need to assess the accuracy of the individual mathematical models.

A Good Practice Guide for Organizing the Scientific Program of International Conferences.

This paper provides a step-by-step guide for organizing the scientific program (OSP) of international conferences. Through informal discussions, a panel of experts organizing international conferences came up with this guide, which includes a flowchart, checklist, and detailed discussions of each step. Subsequently, additional specialists were invited to evaluate this synopsis and provide their input. All of the participants approved the final version after the outline was improved. This guide proposes the following six steps: 1) preparation, 2) recruitment, 3) building the agenda, 4) cross-checking the program, 5) reviewing and finalizing, and 6) in-conference refining. Thirteen items are specified across the six main steps in a detailed checklist. This OSP guide includes a flowchart and a checklist for providing a comprehensive manual for establishing, conducting, and organizing international scientific conferences. Understanding the procedures that are expected to be followed when holding a scientific conference enables the involved parties to organize and assign tasks to one another as well as create a schedule that allows them to finish their work on time. This guide can be used at any kind of scientific conference to describe an organized process, resulting in a professional and distinguished scientific program.

Etiologies and hearing status in bilateral vestibulopathy: a retrospective study of 315 patients.

Importance: The development of a vestibular implant has reached milestones and seems to be a promising therapeutic tool for bilateral vestibulopathy (BV). Given the former lack of therapeutic options for BV, the disease has received scant attention in the previous research literature. It is therefore of major importance to gain more insight into the underlying pathology of BV. Furthermore, as some research groups specifically use a combined vestibulo-cochlear implant, the size of the group of BV patients with associated hearing loss is of special interest. Objectives: The study aimed to determine the definite and probable etiology in bilateral vestibulopathy (BV) patients and to report on their hearing status. Design: This study involves multicenter retrospective study design. Setting: The research setting is at tertiary referral centers. Participants: Consecutive BV patients diagnosed at the Antwerp University Hospital between 2004 and 2018 at the Maastricht University Medical Center between 2002 and 2015 and at the Geneva University Hospital between 2013 and 2018, who met the BV diagnostic criteria of the Bárány Society. Main outcome measures: Primary interests were the etiology and hearing status of BV patients. Moreover, the data of vestibular tests were examined (caloric irrigation, rotatory chair tests, and video-head impulse test). Results: The authors identified 315 BV patients, of whom 56% were male patients. Mean age at diagnosis was 58.6 ± 15.1 (range 7-91) years. The definite cause was determined in 37% of the patients and the probable cause in 26% of the patients. No cause was identified in 37% of BV patients. The largest subgroup included patients with genetic etiology (31%), most frequently COCH mutation. Only 21% of patients (n = 61) had bilateral normal hearing. Almost half of the patients (45%, n = 134) had profound hearing loss in at least one ear. Conclusion: BV is a heterogeneous condition, with over a third of cases remaining idiopathic, and nearly three-quarters affected by hearing loss. COCH mutation is the most common non-idiopathic cause of BV in our population. Only 21% of our BV patients presented with bilateral normal hearing.

QoL, CIs, QALYs, and Individualized Rehabilitation: The Clinical and Practical Benefits of Regularly Assessing the Quality of Life of Adult Cochlear Implant Recipients.

This study aimed to report quality of life (QoL) scores in unilateral cochlear implant (CI) users and to generate guidance for clinicians on using QoL measures to individualize CI counselling and rehabilitation and to increase access to CIs as a mode of rehabilitation. Participants (n = 101) were unilateral CI users with single-sided deafness (SSD; n = 17), asymmetrical hearing loss (AHL; n = 26), or bilateral hearing loss (Uni; n = 58). Generic QoL was assessed via the Health Utilities Index (HUI-3), and disease-specific QoL was assessed via the Speech, Spatial, and Qualities of Hearing scale (SSQ12) and Nijmegen CI Questionnaire (NCIQ) at preimplantation and at 6 and 12 months of CI use. All groups had significantly increased HUI-3 scores at both intervals. The SSD group showed significant benefit on the SSQ12 at visit 3, the AHL group showed significant benefit on the SSQ12 and most NCIQ subdomains at both intervals, and the Uni group showed significant benefit with both tests at both intervals. Unilateral CI recipients demonstrate improved QoL within the first 12 months of device use. Regular assessment with generic and disease-specific questionnaires has the potential to play an important role in personalizing treatment and possibly in increasing access to CI provision.

Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation.

Impedance measurements are routinely performed during cochlear implantation (CI) after finalized electrode insertion. They may allow conclusions on the electrode's and implant's function. In the postoperative setting, the analysis of impedance changes enables the identification of scarring or inflammation processes around the electrode. Recent studies report associations between impedance telemetry and the site of stimulation. Consequently, repeated impedance measurements during cochlear implant electrode insertion may enable objective feedback on whether the electrode is positioned inside the perilymph or outside the inner ear. With the presented novel method, impedances can be measured in real-time during cochlear implantation. This protocol systematically explains how to perform repeated impedance recordings during CI surgery. These repeated measurements are challenging since they depend on multiple intraoperative methodological factors starting with the draping of the patient. Thus, for successful recordings, a standardized procedure is mandatory. In this article, we comprehensively illustrate the system setup and procedure of performing intraoperative measurements during CI surgery.

Accuracy of Preoperative Cochlear Duct Length Estimation and Angular Insertion Depth Prediction.

OBJECTIVE: In cochlear implantation with flexible lateral wall electrodes, a cochlear coverage of 70% to 80% is assumed to yield an optimal speech perception. Therefore, fitting the cochlear implant (CI) to the patient's individual anatomy has gained importance in recent years. For these reasons, the optimal angular insertion depth (AID) has to be calculated before cochlear implantation. One CI manufacturer offers a software that allows to visualize the AID of different electrode arrays. Here, it is hypothesized that these preoperative AID models overestimate the postoperatively measured insertion angle. This study aims to investigate the agreement between preoperatively estimated and postoperatively measured AID. STUDY DESIGN: Retrospective cross-sectional study. SETTING: Single-center tertiary referral center. PATIENTS: Patients undergoing cochlear implantation. INTERVENTION: Preoperative and postoperative high-resolution computed tomography (HRCT). MAIN OUTCOME MEASURES: The cochlear duct length was estimated by determining cochlear parameters ( A value and B value), and the AID for the chosen electrode was (i) estimated by elliptic circular approximation by the software and (ii) measured manually postoperatively by detecting the electrode contacts after insertion. RESULTS: A total of 80 HRCT imaging data sets from 69 patients were analyzed. The mean preoperative AID estimation was 662.0° (standard deviation [SD], 61.5°), and the mean postoperatively measured AID was 583.9° (SD, 73.6°). In all cases (100%), preoperative AID estimation significantly overestimated the postoperative determined insertion angle (mean difference, 38.1°). A correcting factor of 5% on preoperative AID estimation dissolves these differences. CONCLUSIONS: The use of an electrode visualization tool may lead to shorter electrode array choices because of an overestimation of the insertion angle. Applying a correction factor of 0.95 on preoperative AID estimation is recommended.

Differential effect of panic on the DNA methylation of the glucocorticoid receptor gene exon 1F in chronic subjective tinnitus with distress.

OBJECTIVE: Tinnitus can be regarded as a chronic stressor, leading to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. There is important comorbidity with anxiety, particularly panic, potentially associated with differences in HPA axis functioning and methylation patterns of HPA axis-related genes. This study examines DNA methylation of the glucocorticoid receptor gene ( NR3C1 ) exon 1F in adults with chronic subjective tinnitus and the possible differential effect of panic. METHODS: In a well characterized tinnitus sample ( n  = 22, half of which had co-occurring panic attacks), and unaffected controls ( n  = 31) methylation patterns of the CpG sites were determined using pyrosequencing and compared between groups through linear mixed models. Gene expression was determined using quantitative PCR on mRNA. RESULTS: Comparing the combined tinnitus groups to the control group, no DNA methylation differences were observed; however, the tinnitus group with panic attacks showed consistently higher mean methylation values across all CpGs compared to the tinnitus-only and the control group ( P  = 0.03 following Tukey correction), which became even more pronounced when accounting for childhood trauma ( P  = 0.012). Moreover, a significant positive correlation was found between methylation of the CpG7 site and the Beck Anxiety Inventory total score ( P  = 0.001) in the total population. NR3C1 -1F expression was not significantly different between the three groups. CONCLUSION: Panic is associated with higher DNA methylation of the NR3C1 exon 1F in adults with chronic subjective tinnitus, consistent with the reduced negative glucocorticoid feedback and HPA axis hyperfunction observed in individuals with panic disorder.

Efficacy and Safety of Intranasal Betahistine in the Treatment of Surgery-Induced Acute Vestibular Syndrome: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study.

OBJECTIVE: To evaluate the safety and efficacy of AM-125 nasal spray (intranasal betahistine) in the treatment of surgery-induced acute vestibular syndrome (AVS). STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled exploratory phase 2 study with dose escalation (part A) followed by parallel dose testing (part B); open-label oral treatment for reference. SETTING: Twelve European study sites (tertiary referral centers). PATIENTS: One hundred and twenty-four patients 18 to 70 years old undergoing surgery for vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy with confirmed bilateral vestibular function presurgery and acute peripheral vertigo postsurgery. INTERVENTIONS: AM-125 (1, 10, or 20 mg) or placebo or betahistine 16 mg p.o. t.i.d. for 4 weeks, starting 3 days postsurgery; standardized vestibular rehabilitation. MAIN OUTCOME MEASURES: Tandem Romberg test (TRT) for primary efficacy, standing on foam, tandem gait, subjective visual vertical and spontaneous nystagmus for secondary efficacy, Vestibular Rehabilitation Benefit Questionnaire (VRBQ) for exploratory efficacy; nasal symptoms and adverse events for safety. RESULTS: At treatment period end, mean TRT improvement was 10.9 seconds for the 20-mg group versus 7.4 seconds for the placebo group (mixed model repeated measures, 90% confidence interval = 0.2 to 6.7 s; p = 0.08). This was corroborated by nominally higher frequency of complete spontaneous nystagmus resolution (34.5% vs. 20.0% of patients) and improvement in the VRBQ; the other secondary endpoints showed no treatment effect. The study drug was well tolerated and safe. CONCLUSIONS: Intranasal betahistine may help accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction in surgery-induced AVS. Further evaluation in a confirmatory manner appears warranted.

Audiological outcomes of robot-assisted cochlear implant surgery.

PURPOSE: The main objective of this study is to evaluate the short-term and long-term audiological outcomes in patients who underwent cochlear implantation with a robot-assisted system to enable access to the cochlea, and to compare outcomes with a matched control group of patients who underwent cochlear implantation with conventional access to the cochlea. METHODS: In total, 23 patients were implanted by robot-assisted cochlear implant surgery (RACIS). To evaluate the effectiveness of robotic surgery in terms of audiological outcomes, a statistically balanced control group of conventionally implanted patients was created. Minimal outcome measures (MOM), consisting of pure-tone audiometry, speech understanding in quiet and speech understanding in noise were performed pre-operatively and at 3 months, 6 months, 12 months and 2 years post-activation of the audioprocessor. RESULTS: There was no statistically significant difference in pure-tone audiometry, speech perception in quiet and speech perception in noise between robotically implanted and conventionally implanted patients pre-operatively, 3 months, 6 months, 12 months and 2 years post-activation. A significant improvement in pure-tone hearing thresholds, speech understanding in quiet and speech understanding in noise with the cochlear implant has been quantified as of the first measurements at 3 months and this significant improvement remained stable over a time period of 2 years for HEARO implanted patients. CONCLUSION: Clinical outcomes in robot-assisted cochlear implant surgery are comparable to conventional cochlear implantation. CLINICALTRAILS. GOV TRAIL REGISTRATION NUMBERS: NCT03746613 (date of registration: 19/11/2018), NCT04102215 (date of registration: 25/09/2019).

A Novel Representation of Audiological and Subjective Findings for Acoustical, Bone Conduction and Direct Drive Hearing Solutions.

BACKGROUND: The benefit of hearing rehabilitation is often measured using audiological tests or subjective questionnaires/interviews. It is important to consider both aspects in order to evaluate the overall benefits. Currently, there is no standardized method for reporting combined audiological and patient reported subjective outcome measures in clinical practice. Therefore, this study focuses on showing the patient's audiological, as well as subjective outcomes in one graph using data from an existing study. METHOD: The present paper illustrated a graph presenting data on four quadrants with audiological and subjective findings. These quadrants represented speech comprehension in quiet (unaided vs. aided) as WRS% at 65 dB SPL, speech recognition in noise (unaided vs. aided) as SRT dB SNR, sound field threshold (unaided vs. aided) as PTA4 in dB HL, wearing time and patient satisfaction questionnaire results. RESULTS: As an example, the HEARRING graph in this paper represented audiological and subjective datasets on a single patient level or a cohort of patients for an active bone conduction hearing implant solution. The graph offered the option to follow the user's performance in time. CONCLUSION: The HEARRING graph allowed representation of a combination of audiological measures with patient reported outcomes in one single graph, indicating the overall benefit of the intervention. In addition, the correlation and consistency between some results (e.g., aided threshold and aided WRS) can be better visualized. Those users who lacked performance benefits on one or more parameters and called for further insight could be visually identified.

Evaluation of Cognitive Functioning Before and After Cochlear Implantation in Adults Aged 55 Years and Older at Risk for Mild Cognitive Impairment.

Importance: Given the rapidly rising dementia incidence, management of modifiable risk factors, such as hearing loss, is vital. Multiple studies have demonstrated an improvement of cognitive functioning in older adults with severe hearing loss after cochlear implantation; however, few of these studies, to the authors' knowledge, specifically analyzed participants achieving poor cognitive results preoperatively. Objective: To evaluate the cognitive functioning of older adults with severe hearing loss at risk for mild cognitive impairment (MCI) before and after cochlear implantation. Design, Setting, and Participants: This prospective, longitudinal cohort study performed at a single center reports data obtained over a 6-year period (April 2015 to September 2021) of an ongoing prospective, longitudinal cohort study on cochlear implant outcomes in older adults. A consecutive sample of older adults with severe hearing loss eligible for cochlear implantation was included. All participants obtained a Repeatable Battery for the Assessment of Neuropsychological Status for hearing-impaired patients (RBANS-H) total score indicative of MCI preoperatively. Participants were assessed before cochlear implant activation and 12 months after cochlear implant activation. Intervention: The intervention consisted of cochlear implantation. Main Outcome and Measure: The primary outcome measure was cognition, measured by the RBANS-H. Results: A total of 21 older adult cochlear implant candidates were included in the analysis (mean [SD] age, 72 [9] years; 13 [62%] men). Cochlear implantation was associated with an improvement of overall cognitive functioning 12 months after activation (median [IQR] percentile, 5 [2-8] vs 12 [7-19]; difference, 7 [95% CI, 2-12]). Eight participants (38%) surpassed the MCI cutoff (16th percentile) postoperatively, while the overall median cognitive score remained under this cutoff. In addition, participants' speech recognition in noise improved, with a lower score indicating improvement (mean [SD] score, +17.16 [5.45] vs +5.67 [6.3]; difference, -11.49 [95% CI, -14.26 to -8.72]), after cochlear implant activation. Improvement of speech recognition in noise was positively associated with improvement in cognitive functioning (rs, -0.48 [95% CI, -0.69 to -0.19]). Years of education, sex, RBANS-H version, and symptoms of depression and anxiety were not related to the evolution in RBANS-H scores. Conclusions and Relevance: In this prospective, longitudinal cohort study, cognitive functioning and speech perception in noise showed a clinically meaningful improvement 12 months after cochlear implant activation in older adults with severe hearing loss at risk for MCI, suggesting that cochlear implantation is not contraindicated in cochlear implant candidates with cognitive decline and should be considered after multidisciplinary evaluation.

Robotic cochlear implantation in post-meningitis ossified cochlea.

AIM: To report the experience of an image-guided and navigation-based robot arm as an assistive surgical tool for cochlear implantation in a case with a labyrinthitis ossificans. PATIENT: A 55-years-old man with a history of childhood meningitis whose hearing deteriorated progressively to bilateral profound sensorineural hearing loss. INTERVENTION: Robotic Assisted Cochlear Implant Surgery (RACIS) with a straight flexible lateral wall electrode. PRIMARY OUTCOME MEASURES: Electrode cochlear insertion depth with RACIS with facial recess approach and autonomous inner ear access with full electrode insertion of a flexible straight cochlear implant array. CONCLUSIONS: Intra cochlear ossifications pose a challenge for entering the cochlea and full-length insertion of a cochlear implant. RACIS has shown that computations of radiological images combined with navigation-assisted robot arm drilling can provide efficient access to the inner ear.

Effect of Cochlear Implant Electrode Insertion Depth on Speech Perception Outcomes: A Systematic Review.

Objective: The suitable electrode array choice is broadly discussed in cochlear implantation surgery. Whether to use a shorter electrode length under the aim of structure preservation versus choosing a longer array to achieve a greater cochlear coverage is a matter of debate. The aim of this review is to identify the impact of the insertion depth of a cochlear implant (CI) electrode array on CI users' speech perception outcomes. Databases Reviewed: PubMed was searched for English-language articles that were published in a peer-reviewed journal from 1997 to 2022. Methods: A systematic electronic search of the literature was carried out using PubMed to find relevant literature on the impact of insertion depth on speech perception. The review was conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines of reporting. Studies in both, children and adults with pre- or postlingual hearing loss, implanted with a CI were included in this study. Articles written in languages other than English, literature reviews, meta-analyses, animal studies, histopathological studies, or studies pertaining exclusively to imaging modalities without reporting correlations between insertion depth and speech outcomes were excluded. The risk of bias was determined using the "Risk of Bias in Nonrandomized Studies of Interventions" tool. Articles were extracted by 2 authors independently using predefined search terms. The titles and abstracts were screened manually to identify studies that potentially meet the inclusion criteria. The extracted information included: the study population, type of hearing loss, outcomes reported, devices used, speech perception outcomes, insertion depth (linear insertion depth and/or the angular insertion depth), and correlation between insertion depth and the speech perception outcomes. Results: A total of 215 relevant studies were assessed for eligibility. Twenty-three studies met the inclusion criteria and were analyzed further. Seven studies found no significant correlation between insertion depth and speech perception outcomes. Fifteen found either a significant positive correlation or a positive effect between insertion depth and speech perception. Only 1 study found a significant negative correlation between insertion depth and speech perception outcomes. Conclusion: Although most studies reported a positive effect of insertion depth on speech perception outcomes, one-third of the identified studies reported no correlation. Thus, the insertion depth must be considered as a contributing factor to speech perception rather than as a major decisive criterion. Registration: This review has been registered in PROSPERO, the international prospective register of systematic reviews (CRD42021257547), available at https://www.crd.york.ac.uk/PROSPERO/.

The Online HEARRING Counselling 1.0 Platform Provides Clinicians with Comprehensive Information on Hearing Device Solutions for Conductive, Mixed, and Sensorineural Hearing Loss.

A platform to help clinicians ensure that hearing device candidates are informed about the benefits and drawbacks of their recommended treatment option would be of clinical counselling benefit because it could help each candidate form realistic expectations about life with their treatment option. Following the World Café approach, 54 participants (surgeons, audiologist, and researchers) generated lists of the benefits and drawbacks of each treatment option for single-sided deafness (SSD) and bone conduction (BC) solutions. They then prioritized the benefits and drawbacks. After the World Café, literature research was performed on each topic to check if the statements (on benefits and drawbacks) are supported by quality peer-reviewed publications. Each participant was surveyed to ensure a collective agreement was reached. The HEARRING Counselling 1.0 Platform was developed. Thus far, sections for SSD and BC solutions have been completed. Initial feedback has been highly positive. The platform will be expanded to cover middle ear implant solutions and cochlear implants. A plan is in place to ensure the information continues to be timely. The HEARRING Counselling 1.0 helps clinicians provide comprehensive information to candidates about their treatment option and thereby helps establish that candidates have realistic expectations about the benefits and drawbacks of device use.

A novel three-step process for the identification of inner ear malformation types.

Objective: We hypothesize that visualizing inner-ear systematically in both cochlear view (oblique coronal plane) and in mid-modiolar section (axial plane) and following three sequential steps simplifies, identification of inner-ear malformation types. Methods: Pre-operative computer-tomography (CT) scans of temporal bones of 112 ears with various inner ear malformation (IEM) types were taken for analysis. Images were analyzed using DICOM viewers, 3D slicer, and OTOPLAN®. The inner-ear was captured in the oblique-coronal plane for the measurement of length and width of cochlear basal turn which is also called as A-, and B-values respectively (Step 1). In the same plane, the angular-turns of lateral-wall (LW) of cochlear basal turn were measured (Step 2). As Step 3, the mid-modiolar section of inner ear was captured in the axial plane by following the A-value and perpendicular to cochlear view. From the mid-modiolar section, the outer-contour of inner ear was captured manually by following contrasting gray area between fluid filled and bony promontory and was compared to known resembling objects to identify IEM types (Step 3). Results: Following reference values have emerged from our analysis: A-, and B-values (Step 1) on average are >8 mm and >5.5 mm respectively, in normal cochleae (NA), enlarged vestibular aqueduct syndrome (EVAS), incomplete partition (IP) type-I and -II, whereas it is <8 mm and <5.5 mm respectively, in IP type-III and cochlear hypoplasia (CH). Angular-turn of LW is consistently observed in cochlear basal turn (Step 2), is 540° in NA and EVAS, 450° in IP-II, and 360° in IP types I & III. In subjects with CH type, angular-turn of LW is either 360° or 450° or 540°. In true mid-modiolar section, outer-contour of inner-ear (Step-3), other than in CH and cystic inner-ear malformations, resembles recognizable shapes of known objects. Absence of EVA is an additional characteristic that confirms diagnosis of CH when the A-, B-values, and angular-turn of LW can be similar to other anatomical types. Drawing a straight line along posterior edge of internal auditory canal (IAC) in axial view can differentiate a true common cavity (CC) from cochlear aplasia-vestibular cavity (VC). Conclusion: Three-step process proposed in this study captures inner-ear in cochlear view as well in mid-modiolar sections visualizing key features of inner-ear in identification of IEM types. Level of Evidence: Level 1.

Dual-site transcranial direct current stimulation to treat tinnitus: a randomized controlled trial.

Transcranial direct current stimulation (tDCS) has been proposed as a potential intervention for subjective tinnitus, but supporting evidence remains limited. We aimed to investigate the effect of anodal high-definition tDCS of the left temporal area and right dorsolateral prefrontal cortex on tinnitus severity. This double-blind randomized controlled trial included 77 patients (age range 18-79, 43 male) with chronic subjective tinnitus as their primary complaint. Thirty-eight subjects received six consecutive sessions of dual-site sequential high-definition-tDCS with electrodes positioned over the left temporal area and right dorsolateral prefrontal cortex. Both areas were stimulated for 15 min per session, with total stimulation time amounting to 30 min. Thirty-nine subjects received sham stimulation. The primary outcome measure was the change in tinnitus severity, as evaluated by the Tinnitus Functional Index, from baseline to a follow-up visit at 8 ± 2 weeks after treatment completion. Secondary outcomes included changes in perceived tinnitus loudness, as measured with a visual analogue scale and a tinnitus matching procedure, as well as scores on the Hospital Anxiety and Depression Scale, and the Hyperacusis Questionnaire. No differences in Tinnitus Functional Index change scores were identified between the active treatment and sham control groups (linear regression: P = 0.86). The Tinnitus Functional Index scores decreased significantly over time in both groups (P = 0.0012), indicating the presence of a considerable placebo effect. These change scores were significantly influenced by sex (linear regression: P = 0.037) and baseline symptoms of anxiety (linear regression: P = 0.049) in both groups. In general, Tinnitus Functional Index scores decreased more profoundly in males and in subjects with a higher degree of anxiety at baseline. None of the included secondary measures differed significantly between experimental arms. Our results suggest that dual-site sequential high-definition-tDCS of the left temporal area and right dorsolateral prefrontal cortex does not alleviate tinnitus severity. Interestingly, in our study population, fluctuations in tinnitus severity were influenced by gender and concurrent mental condition. It is therefore important to take these factors into account when conducting or planning randomized controlled trials in tinnitus populations.

Subjective perception of activity level: A prognostic factor for developing chronic dizziness after vestibular schwannoma resection?

Introduction: A vestibular schwannoma (VS) resection causes an acute unilateral vestibular deafferentation resulting in acute postoperative symptoms. Despite the expected resolution of most of the symptoms, due to central vestibular compensation, more than one out of four patients develop chronic dizziness. Several predictive factors, such as age and tumor size, have been suggested. Despite its potential effect on the process of central vestibular compensation, the level of physical activity after VS resection was not yet considered. Therefore, the association between the level of physical activity and chronic dizziness after VS resection will be investigated. Methods: This retrospective cohort study included 66 patients who underwent a retro-sigmoid VS resection between October 2001 and February 2007. Patients were assessed before surgery and at 9 weeks and 6 months postoperatively. At 9 weeks, patients were asked to report their level of physical activity (PA) during the past week by using a visual analogue scale and their balance performance was assessed by four standing balance conditions with eyes closed and the Timed Up and Go test (TUG). Based on the Dizziness Handicap Inventory (DHI) score at 6 months, patients were divided in a chronic dizziness group (DHI > 30) and non-chronic dizziness group (DHI-score ≤ 30). Age, sex, Koos classification, preoperative vestibular function, treatment group, balance performance, and level of PA were compared between both groups and used as independent variables in linear regression analyses with the DHI score at 6 months as dependent variable. Results: The chronic dizzy patients revealed to have significantly lower levels of PA (p < 0.001) and worse static and dynamic balance performance (p = 0.023 and p = 0.041, respectively) 9 weeks after surgery. After elimination, the multiple regression analysis resulted in a model with two variables (PA level, TUG) which significantly predicted the DHI score (F 2,42 = 6.581; R 2 = 0.239; p = 0.003). Conclusion: This study revealed associations between (1) the level of PA and balance performance in the subacute phase and (2) chronic dizziness after VS resection. Assessment of the level of PA and balance performance during the subacute phase, which can be performed in a non-invasive and non-time-consuming way, might therefore provide prognostic information after VS resection.

The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness.

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions. METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting. RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set. CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.