Medical Devices-Evidence and Research最新文献

{"title":"A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study.","authors":"Jia Li","doi":"10.2147/MDER.S558998","DOIUrl":"10.2147/MDER.S558998","url":null,"abstract":"<p><p>International biomechanical standards, such as ISO 10328 for lower-limb prosthetic testing, are widely used to guide device evaluation, yet their direct adoption into national regulatory systems often results in mismatches in safety expectations, documentation formats, and contextual use conditions. Despite extensive reliance on ISO standards, there is no structured method to assess whether these standards are appropriately aligned with regulatory requirements across different jurisdictions. This narrative review, combined with a conceptual framework and an illustrative cross-jurisdictional case study, proposes a multi-dimensional applicability index designed to evaluate the regulatory fit of international biomechanical standards before national adoption. The index comprises five dimensions clinical safety alignment, technical fit, contextual usability, documentation conformance, and regulatory interoperability, each providing a structured lens for assessing standard suitability. Using ISO 10328 and a representative prosthetic knee device as an example, the study demonstrates how the index highlights areas of strong technical alignment but also reveals gaps related to usability, documentation, and post-market expectations across the U.S. FDA, EU MDR, and China's GB/NMPA systems. The findings underscore the need for context-aware evaluation tools to complement global standards, reducing approval delays and improving device performance in real-world environments. This work provides a foundational methodology for regulators, manufacturers, and standards bodies seeking to harmonize global testing norms while ensuring national regulatory relevance and patient safety.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"558998"},"PeriodicalIF":1.5,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13038417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147610268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Research of Multi Segment Exoskeleton Reconfigurable Soft Finger Actuator.","authors":"Zhilin Zhang, Aldrin D Calderon, Junliang Lai, Helin Wang, Xianhao Hu, Daonan Chen, Chuanjian Liang","doi":"10.2147/MDER.S476462","DOIUrl":"10.2147/MDER.S476462","url":null,"abstract":"<p><strong>Purpose: </strong>The growing number of patients with hand dysfunction caused by conditions such as stroke has led to increasing demand for soft finger rehabilitation actuators. However, existing devices of this type often face issues such as irregular deformation, insufficient driving force, the inability to achieve segmented control, and poor rigidity retention.</p><p><strong>Methods: </strong>A multi-segment exoskeleton design is proposed, which achieves a functional separation between actuation and load-bearing. Utilizing the principle of virtual work and the Yeoh constitutive model, derive the pressure-to-angle transfer function to facilitate the establishment of the overall equation of motion.</p><p><strong>Results: </strong>The finite element analysis and experimental tests conducted in this study prove that the design prevents irregular deformation, enables segmented control, and maintains high rigidity. Through physical testing, a maximum bending angle of 338.7° and a maximum driving force of 11.50 N were achieved, which is 25.27% higher than the 9.18 N force found in existing studies.</p><p><strong>Conclusion: </strong>The multi-segment reconfigurable soft finger exoskeleton actuator proposed in this study demonstrates significant advantages over conventional devices, with its enhanced bending range and force output facilitating patients' performance of daily grasping tasks. The segmented control capability enables personalized rehabilitation training targeting specific finger joints. This innovation holds substantial promise for improving hand function recovery in stroke patients.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"476462"},"PeriodicalIF":1.5,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13025834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying Changes in Balance, Gait, Fall Risk, and Sensory Reweighting in Older Adults Following Multi-Session Electrical Vestibular Stimulation Therapy.","authors":"John D Ralston, Scott Stanley, Joshua M Roper, Osman Darici, Ryan M Peters","doi":"10.2147/MDER.S590344","DOIUrl":"10.2147/MDER.S590344","url":null,"abstract":"<p><strong>Objective: </strong>To assess the utility of digital biomarkers derived from a head-mounted wearable physiological vibration acceleration (phybrata) sensor for quantifying changes in balance, gait, fall risk, and sensory reweighting in older adults undergoing multi-session electrical vestibular stimulation therapy (eVST).</p><p><strong>Methods: </strong>Data were collected and analyzed from 32 residents aged 60-98 yrs from a continuing care retirement community before, during, and after the administration of an 18-session eVST treatment protocol delivered over a 4-6-week period. Each session included subthreshold wideband stochastic electrical vestibular stimulation (swsEVS) for 20 minutes delivered using a wearable device. Balance performance, sensory reweighting, and fall risk were assessed immediately before and after treatment using a head-mounted phybrata sensor. Two additional standard balance tests, along with wearable-sensor-based gait assessments, were administered before the 1^st and after the 18^th treatment session.</p><p><strong>Results: </strong>30 of the 32 participants demonstrated significantly improved balance and gait performance and reduced fall risk following the 18-session eVST treatment protocol. Phybrata sensory reweighting profiles for the study participants as a group revealed significant recovery of vestibular balance regulation and decreased reliance on proprioception. Phybrata biomarkers were found to identify the 2 non-responders in the study population within the first 2 treatment sessions. The number of participants classified as \"high fall risk\" decreased from 19 to 4 following treatment. Significant stabilization of head movement was observed following eVST treatment using head-mounted sensors during gait tests over distances as short as 7.6m, with the largest reductions observed in the medial-lateral direction. Head-acceleration based gait biomarkers were found to be more sensitive to eVST-induced improvements than stride-to-stride gait parameters measured using foot-mounted sensors.</p><p><strong>Conclusion: </strong>Phybrata digital biomarkers enable rapid objective assessment of changes in balance, gait, fall risk, and sensory reweighting in older adults before, during, and after a multi-session eVST treatment protocol.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"590344"},"PeriodicalIF":1.5,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13015830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147522264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective Multicenter Evaluation of Patient Satisfaction and Radiologist Image Interpretation Using the Envision™ Mammography Platform.","authors":"Chirag R Parghi, Paul J Niklewski, Alexis Cooper, Muhammad Waqas","doi":"10.2147/MDER.S560551","DOIUrl":"10.2147/MDER.S560551","url":null,"abstract":"<p><strong>Purpose: </strong>Improving image quality without increasing patient discomfort remains a challenge in mammography. This study evaluated the ability of the Envision™ platform in a prospective, multicenter observational case-collection study (NCT05199701), focusing on patient comfort and radiologist-assessed image quality.</p><p><strong>Patients and methods: </strong>Across nine US breast-imaging sites, 929 women aged ≥35 years undergoing a clinically indicated screening or diagnostic mammogram, or a mammogram in the context of a recommended biopsy, were enrolled. All subjects received a standard four-view bilateral exam (RCC, RMLO, LCC, LMLO) on the Envision platform. Radiologists rated image quality (positioning, contrast, sharpness, tissue visibility, noise, artifacts, and overall clinical image quality) using a three-category scale (<i>requires reimaging, acceptable, excellent</i>). Patient comfort and device preference were assessed via questionnaire. Analyses were descriptive.</p><p><strong>Results: </strong>Most subjects (79%) preferred the investigational mammogram over prior mammograms, and 70% reported greater compression comfort. Discomfort scores were low: 34% reported no discomfort (0/10) and 52.5% reported minimal discomfort (1-2/10). Radiologists rated the majority of images acceptable or excellent, with excellent ratings of 41.9-48.5% for contrast, 41.8-42.0% for sharpness, 50.2-50.5% for tissue visibility, and 33.4-34.5% for artifacts. Repeat-imaging recommendations were infrequent (0-6.6% across views), and overall clinical image quality was acceptable or excellent in 94.1-100% of images.</p><p><strong>Conclusion: </strong>The Envision platform produced consistently high levels of clinically acceptable image quality while maintaining or improving patient comfort compared to prior mammography experiences. These findings support its feasibility for routine clinical use.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"560551"},"PeriodicalIF":1.5,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13019162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inter- and Intrarater Reliability of a Novel Ultrasound Doppler Device (earlybird) for Quantitative Assessment of Peripheral Arterial Flow.","authors":"Marie Tryland Høiberg, Stine Marie Pauschert Kvamme, Steffen Felle Bentsen, Karoline Løkken, Gudrun Rohde, Hans Torp, Arne Seternes, Erik Mulder Pettersen","doi":"10.2147/MDER.S579251","DOIUrl":"10.2147/MDER.S579251","url":null,"abstract":"<p><strong>Objective: </strong>Growing interest in quantitative Doppler assessment has underscored the need for reliable, operator-independent tools to evaluate peripheral arterial circulation. This study aimed to evaluate the reliability of a novel ultrasound Doppler device (earlybird) for measuring blood-flow velocity in lower-extremity arteries and to validate its consistency across raters. We further explored multiple hemodynamic parameters derived from the Doppler spectrogram to examine their reproducibility and potential clinical applicability.</p><p><strong>Methods: </strong>Thirty-five participants, including 25 with varying degrees of peripheral arterial disease (PAD) and 10 healthy individuals, were recruited. Four raters performed independent measurements of the peripheral blood-flow velocity in each participant (280 measurements). Six blood-flow parameters were extracted from the Doppler spectrograms: peak systolic velocity (PSV), time-averaged velocity (TAV), end-diastolic velocity (EDV), pulsatility index (PI), resistive index (RI), and acceleration time (AT). The intraclass correlation coefficient (ICC) was used to assess reliability, which was visualized in scatter plots and Bland-Altman plots with 95% limits of agreement.</p><p><strong>Results: </strong>Good correlation and agreement among the different raters were observed, with inter-rater reliability ranging from an ICC of 0.755-0.835 (<i>p</i> < 0.001). Intra-rater reliability showed poor to excellent correlation, with ICCs ranging from 0.450 to 0.961, (<i>p</i> < 0.001). Bland-Altman plots revealed wide 95% limits of agreement for PSV, TAV, EDV, and PI, but narrower limits for RI (-9.8% to 9.8%) and AT (-17.3% to 17.1%).</p><p><strong>Conclusion: </strong>Earlybird was shown to be a reliable tool for assessing peripheral arteries across raters, with good inter- and intra-rater reliability. The angle-independent variables, RI and AT, showed narrow 95% limits of agreement, which justifies further exploration.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"579251"},"PeriodicalIF":1.5,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13005978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evidence of the Utility of Needle-Free Injectable Devices for Subcutaneous Administration of Biopharmaceuticals: Comparable Study of in vivo Pharmacological and Vaccination Ability to Normal Injection.","authors":"Toru Taharabaru, Yuto Kubohira, Kensuke Taniguchi, Taiji Horita, Taishi Higashi, Keiichi Motoyama","doi":"10.2147/MDER.S582443","DOIUrl":"10.2147/MDER.S582443","url":null,"abstract":"<p><strong>Background: </strong>Needle-free injectable (NFI) technology has attracted increasing attention as a promising alternative to conventional needle-based injections. NFI devices offer several advantages, including reduced pain, minimized medical waste, and the elimination of needlestick injury risks. However, quantitative evidence comparing their pharmacological performance with that of standard subcutaneous (SC) injections remains limited, particularly for different biopharmaceuticals.</p><p><strong>Methods: </strong>We compared a novel NFI device (SAIJECT^®) with conventional needle-based SC injection for the administration of model biopharmaceuticals. The pharmacological activities of insulin were evaluated based on blood glucose levels, including time-dependent hypoglycemic response. The antigen-specific antibody production levels after the injection of Ovalbumin (OVA, a model antigen for vaccination) were also evaluated. Furthermore, the physical mechanism of drug delivery by the NFI device was visualized by studying the penetration of Evans blue dye after injection.</p><p><strong>Results: </strong>There was no significant difference in the pharmacological activities of insulin and OVA delivered via the NFI-device and those via standard SC injection, suggesting that the NFI device was comparable to normal injection. Evans blue dye injected by the NFI device was broadly distributed throughout the dermis and subcutaneous tissue without skin perforation, leakage, or localized accumulation. These results indicate that NFI device can deliver drugs efficiently into the subcutaneous tissue while maintaining tissue integrity. Moreover, this NFI device exhibited negligible drug adsorption, indicating favorable physicochemical compatibility.</p><p><strong>Conclusion: </strong>These findings provide direct evidence supporting the applicability of NFI technology for the SC delivery of biopharmaceuticals and highlight the potential of the NFI devices as a practical and effective alternative to conventional needle-based injection methods. In addition, this comprehensive evaluation of NFI devices provides fundamental insights for the translational application of NFI devices as a practical alternative to needle-based injections.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"582443"},"PeriodicalIF":1.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12978008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147445514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support.","authors":"Nathan C Hurley, Bobak J Mortazavi, Sanket S Dhruva, Joseph S Ross, Che G Ngufor, Jeptha P Curtis, Harlan M Krumholz, Nihar R Desai","doi":"10.2147/MDER.S585943","DOIUrl":"10.2147/MDER.S585943","url":null,"abstract":"<p><strong>Introduction: </strong>Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a heterogeneous clinical syndrome associated with substantial morbidity and mortality. We developed a machine learning-based mortality model to identify features and patient subgroups associated with the largest change in mortality risk when evaluating treatment with Impella devices or intra-aortic Balloon Pump (IABP).</p><p><strong>Methods: </strong>Our cohort comprised 369 sites and 15,796 patient visits to the cardiac catheterization laboratory from the National Cardiovascular Data Registry. We developed XGBoost decision tree models to model mortality with and without treatment variable included (Impella or IABP).</p><p><strong>Results: </strong>The estimated population mean excess mortality effect of treatment with Impella devices vs IABP was 10.4 ± 0.8%. However, we identified clinical subgroups of 282 patients for whom a decreased risk of mortality was associated with use of Impella as compared with IABP. Those patients were on average younger, presented with higher systolic blood pressure, higher rate of salvage percutaneous coronary intervention, higher initial creatinine, and lower hemoglobin.</p><p><strong>Discussion: </strong>While Impella devices were associated with higher mortality risk overall, certain clinical profiles were associated with lower risk, illustrating heterogeneity of treatment effects.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"585943"},"PeriodicalIF":1.5,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12967445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147391416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy for Human Toxoplasmosis: Performance, Populations, and Validation Gaps.","authors":"Dodit Suprianto, Loeki Enggar Fitri, Akhmad Sabarudin, Wayan Firdaus Mahmudy, Muhammad Hatta Prabowo, Werasak Surareungchai","doi":"10.2147/MDER.S569457","DOIUrl":"10.2147/MDER.S569457","url":null,"abstract":"<p><strong>Background: </strong>Accurate and timely diagnosis of toxoplasmosis is crucial for clinical management, particularly in high-risk populations. Despite a diverse diagnostic landscape spanning laboratory-based serology, molecular assays, point-of-care (POC) devices, and emerging technologies, a consolidated quantitative synthesis of their performance and clinical readiness is lacking.</p><p><strong>Methods: </strong>This systematic review and diagnostic test accuracy meta-analysis employed a dual-method design, integrating evidence mapping and quantitative synthesis. We searched Embase, PubMed, Scopus, IEEE Xplore, and other databases from January 1, 2010, to December 31, 2025, for studies evaluating diagnostic tests for human toxoplasmosis. Evidence mapping classified technologies by target, specimen, and validation stage (Tiers 0-3). Meta-analysis pooled sensitivity and specificity using bivariate random-effects models for subgroups with sufficient data. Risk of bias was assessed using QUADAS-2.</p><p><strong>Results: </strong>Evidence mapping identified 175 studies yielding 309 diagnostic test evaluations across 37 target groups, 20 clinical populations, and 11 technological categories. Most studies evaluated conventional laboratory assays (75.9%), followed by point-of-care tests (20.9%) and emerging technologies (3.2%). Meta-analysis included 182 test evaluations (42,287 samples) and showed that accuracy differed by detection target, population, and platform. Among targets, IgG+IgM and IgG avidity demonstrated the strongest combined performance (IgG+IgM sensitivity 94.8% [95% CI 89.4-97.5], specificity 96.7% [93.9-98.3]; IgG avidity sensitivity 90.8% [84.9-94.5], specificity 97.1% [91.7-99.0]), whereas DNA assays showed a rule-in profile with lower sensitivity (66.0% [51.9-77.7]) but high specificity (96.2% [94.3-97.5]). Performance varied across clinical populations, with a notable diagnostic gap in other immunocompromised patients (sensitivity 55.7% [33.1-76.2] despite specificity 97.7% [92.3-99.3]). By platform, POCTs had high specificity (97.4% [95.4-98.5]) and good sensitivity (87.7% [80.3-92.6]) compared with conventional assays (84.7% [80.2-88.3]; 95.5% [94.2-96.6]).</p><p><strong>Conclusion: </strong>Diagnostic accuracy for toxoplasmosis is highly context-dependent. Serology remains central, with IgG avidity (and high-performing IgG+IgM strategies) supporting infection dating, and POCTs offering rapid, high-specificity rule-in utility when embedded in appropriate clinical algorithms. The persistently reduced sensitivity in immunocompromised populations highlights an urgent unmet need for improved diagnostics and more rigorous, standardized real-world validation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"569457"},"PeriodicalIF":1.5,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12967108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147379125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Safety and Efficacy of Disinfection Cap Use in a Real-World Environment.","authors":"Laura Serrano Díaz, Barbara Defilippo, Marita Windpassinger, Sabine Maes, María Elena Gesto Lagüela, Trevor J Steele, Jenny Serrano, Kyle De Boer","doi":"10.2147/MDER.S568196","DOIUrl":"10.2147/MDER.S568196","url":null,"abstract":"<p><strong>Purpose: </strong>Catheter hub and needle-free connector contamination is a causative element in the development of catheter-related bloodstream infections and demonstrates the necessity for effective hub disinfection. The current study evaluated the safety and efficacy of a disinfection cap used in a real-world environment.</p><p><strong>Patients and methods: </strong>This multicenter, single-arm, prospective post-market study was designed to collect clinical data on the safety and performance of a passive disinfection cap. A total of 157 participants were included in this study. The primary performance endpoints were attachment and removal success rates. The primary safety endpoint was the rate of device-related AEs.</p><p><strong>Results: </strong>A total of 156 participants, aged 3-93 years, had at least one disinfection cap applied during the study. Attachment and removal success was ≥ 99.7%. No device-related adverse events were observed.</p><p><strong>Conclusion: </strong>This study found that disinfection caps can be attached and removed successfully with no device-related adverse events in a real-world environment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"568196"},"PeriodicalIF":1.5,"publicationDate":"2026-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12951736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147349515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ocular VEMP Using Bone Conduction Stimuli at the Forehead - A Pilot Study Comparing B250, Minishaker and Tendon Hammer with Vibrometry Validation.","authors":"Bo E V Håkansson, Karl-Johan Fredén Jansson, Luca Verrecchia, Zheer Tawfique, Laura Froehlich, Julia Dlugaiczyk, Torsten Rahne, Måns Eeg-Olofsson, Emil Håkansson, Sabine Reinfeldt","doi":"10.2147/MDER.S560014","DOIUrl":"10.2147/MDER.S560014","url":null,"abstract":"<p><strong>Background: </strong>Bone-conduction stimuli in oVEMP testing offer lower stimulus levels and independence of conductive hearing loss but lack a clinically suitable transducer for excitation. A new bone-conduction transducer (B250) has been developed which is easy to attach and can be directly connected to test stations.</p><p><strong>Objective: </strong>To compare, in a pilot investigation B250, Minishaker and Tendon hammer excitation, used for oVEMP and mastoid vibration measurements.</p><p><strong>Methods: </strong>oVEMPs in three subjects were measured using transducers driven by a 250 Hz condensation single sinus cycle and with a Tendon hammer, all applied at forehead Fz/AFz. Corresponding mastoid velocity was measured using a laser Doppler vibrometer (LDV).</p><p><strong>Results: </strong>B250 and Minishaker often produced dual oVEMP peaks with an early n1 (mean latency: 8.8 ms) and a late n2 response (B250: 12.4/Minishaker: 13.3 ms), and with the Tendon hammer response in between. This finding was supported by a reinvestigation of a previous study (n=15). LDV velocity shows several positive peaks for B250 and one positive peak for the Minishaker. The acceleration response has two peaks 4 ms apart for both transducers, which seem to relate to the early and late oVEMP latencies.</p><p><strong>Conclusion: </strong>B250 may serve as a potential alternative, pending validation in larger samples, to the Minishaker at the forehead, but with care to polarity choice and latency interpretation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"560014"},"PeriodicalIF":1.5,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12912185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}