Medical Devices-Evidence and Research最新文献

{"title":"A Novel Method of Using Passive Electronics to Drive Piezo Transducers in Bone Conduction Hearing Implants.","authors":"Karl-Johan Fredén Jansson, Johannes Kocher, Martin L Johansson","doi":"10.2147/MDER.S631032","DOIUrl":"10.2147/MDER.S631032","url":null,"abstract":"<p><strong>Objective: </strong>Piezoelectric transducers are gaining prominence in hearing implants due to their compatibility with magnetic resonance imaging, but commercial alternatives suffer from excessive power consumption. The objective of this study was to propose and evaluate a method of exclusively using passive electronic components in an implanted electronic circuit with low current consumption for driving of a piezo transducer-based hearing aid implant system.</p><p><strong>Methods: </strong>The study sample was a hearing aid system of a prototype piezo transducer and a commercially available sound processor. Output force level and total harmonic distortion were measured by a skull simulator inside an anechoic test chamber at constant sound pressure levels of 70, 80 and 90 dB SPL. Current consumption measurements and a continuous sound exposure test determined the battery lifetime.</p><p><strong>Results: </strong>The current consumption was 5.6 mA (a battery lifetime of 7-9 days), the maximum total harmonic distortion was 2.15% at 70 dB SPL and maximum power output was 111.7 dB re. 1 µN at 90 dB SPL.</p><p><strong>Conclusion: </strong>The findings of the passive design presented in this study indicate that piezo transducers can be driven by significantly lower current consumption than today's commercially available alternatives that are based on active electronics.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"631032"},"PeriodicalIF":1.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13676872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149221049","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 Novel Device for Pulmonary Expansion Under Simulated Healthy and Neuromuscular Conditions: A Bench Simulation Study.","authors":"Alessandra Carneiro Dorça, Letícia de Araújo Morais","doi":"10.2147/MDER.S626538","DOIUrl":"https://doi.org/10.2147/MDER.S626538","url":null,"abstract":"<p><strong>Background: </strong>Amyotrophic Lateral Sclerosis (ALS) leads to a progressive decline in respiratory function, requiring volumetric expansion techniques to prevent hypoventilation. However, the mechanical performance of devices used for this purpose requires evaluation under controlled conditions in bench simulation studies. Devices, such as the manual resuscitator, are commonly used, but present limitations, including high pressures, variable flow, among others. A novel respiratory muscle training device designed to provide controlled flow and pressure (ILLIFE-T) was developed.</p><p><strong>Objective: </strong>To evaluate the behavior of the variables pressure, volume, and flow during the volumetric expansion technique, comparing the new device with the manual resuscitator and the manual resuscitator + Positive Expiratory Pressure (PEP), using simulated models of healthy and ALS affected lungs.</p><p><strong>Methods: </strong>This bench simulation study used the ASL 5000 simulator, configured with predefined respiratory profiles representing healthy and ALS respiratory conditions. Four repetitions of the volumetric expansion maneuver were performed for each device and simulated respiratory condition, with five insufflations per repetition. One recording was randomly selected from each repetition for analysis, resulting in four observations per device and simulated respiratory condition.</p><p><strong>Results: </strong>In the simulation with healthy respiratory conditions, the new device generated higher pressure (23.38±3.81 cmH₂O), volume (1991.25 ±174.10 mL), and lower flow variability (-1.47±11.43 L/min) compared with the manual resuscitator (12.25±11.73 cmH₂O; 1113.64±131.75 mL; 18.84±61.31 L/min) and the manual resuscitator with PEP valve (16.89±0.64 cmH₂O; 1817.25±86.77 mL; -49.49±9.96 L/min), respectively. In ALS simulated models, the new device also achieved higher pressure (23.69±3.29 cmH₂O) and volume (2235.28±264.74 mL) compared with the manual resuscitator (8.33±8.34 cmH₂O; 563.45±212.03 mL, respectively) and the manual resuscitator with PEP valve (14.89±7.60 cmH₂O; 1449.86±153.09 mL, respectively). Flow values were similar among devices: 15.10 ± 18.00 L/min for the new device, 19.28±56.03 L/min for the manual resuscitator, and 0.18±51.67 L/min for the manual resuscitator with PEP valve.</p><p><strong>Conclusion: </strong>Pressure and volume were higher with the new device in both simulated models. Flow did not differ significantly among devices, although lower variability was descriptively observed with the new device.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"626538"},"PeriodicalIF":1.5,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13634224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149116559","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":"Effects of Low-Intensity Pulsed Ultrasound on the Gut-Brain Axis.","authors":"Xiang Liu, Weiping Li, Cheri Deng, Zachary Fernandez, Yuen Gao, Shuangtao Ma, Chunqi Qian","doi":"10.2147/MDER.S609488","DOIUrl":"10.2147/MDER.S609488","url":null,"abstract":"<p><p>The gut-brain axis is a bidirectional communication network involved in inflammatory, metabolic, and neurobehavioural homeostasis. Low-intensity pulsed ultrasound (LIPUS) is a non-invasive biophysical modality that may influence this axis through acoustic mechanotransduction and downstream changes in inflammatory signalling, epithelial barrier function, microbial ecology, and neuroimmune activity. This mini review synthesizes predominantly preclinical evidence on abdominal and brain-directed LIPUS. Current rodent studies indicate that abdominal stimulation can produce coordinated intestinal, systemic, microbial, and central responses, whereas brain-directed stimulation can be accompanied by improvement in both cerebral inflammation and intestinal pathology. Mechanistic studies outside the gut-brain axis further suggest that mechanosensitive ion channels, focal-adhesion signalling, cytoskeletal remodelling, NF-κB, and inflammasome-related pathways may connect acoustic forces to biological responses. However, no single study has established the complete causal sequence from acoustic stimulation to gut-brain communication. Direct human evidence for LIPUS efficacy in gut-brain axis-related disorders is currently lacking. LIPUS should therefore be regarded as a promising preclinical approach requiring standardized acoustic reporting, independent replication, causal pathway validation, and disease-specific optimization before clinical translation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"609488"},"PeriodicalIF":1.5,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13668374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149197086","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 Novel 3D-Printed Titanium Prosthesis with Osseointegrated Dental Implants for Reconstruction of Segmental Mandibular Defects.","authors":"Gary James Chern-Wei Teoh, Benjamin Chee Wee Ng, Yuchun Liu, Bee Tin Goh","doi":"10.2147/MDER.S616352","DOIUrl":"10.2147/MDER.S616352","url":null,"abstract":"<p><strong>Introduction: </strong>Segmental mandibular defects present complex reconstructive challenges and are associated with significant functional and aesthetic morbidity. While vascularized bone flaps remain the standard for reconstruction, they are associated with donor-site morbidity, prolonged operative times, and limitations in predictable dental rehabilitation. This proof-of-concept study evaluated the mechanical feasibility, in a synthetic bench-top model, of a patient-specific, 3D-printed titanium mandibular prosthesis incorporating conventional dental implants for both dental rehabilitation and biological anchorage via osseointegration.</p><p><strong>Methods: </strong>The prosthesis was digitally designed and fabricated in Ti6Al4V-ELI titanium alloy by powder-bed fusion additive manufacturing. A 25 mm critical-sized segmental defect was created in synthetic polyurethane mandible models, and prototype constructs were assembled with osteosynthesis screws and conventional dental implants engaging the residual mandible. Static load-to-failure testing was performed on a single prototype construct. Dynamic cyclic loading at 40-60 N and 2 Hz for 500,000 cycles was performed on three prototype constructs and a control reconstructed with a conventional 2.5 mm reconstruction plate under an identical protocol.</p><p><strong>Results: </strong>The prosthesis demonstrated accurate fit and reproducible assembly. Static testing resulted in failure at 213.9 N, occurring within the mandible model rather than in the prosthesis, fixation screws, or implant-prosthesis interface. All prototype constructs and the control completed 500,000 cycles without catastrophic failure, visible deformation, or loosening of fixation screws. The change in per-cycle displacement range over testing was small in all constructs and showed no progressive increase, indicating an absence of appreciable plastic deformation. Reverse torque testing demonstrated no implant loosening.</p><p><strong>Conclusion: </strong>This proof-of-concept study supports the mechanical feasibility of a novel 3D-printed titanium mandibular prosthesis under defined loading conditions in a synthetic bench-top model. Osseointegrated dental implants are intended to provide biological anchorage in addition to mechanical fixation, although osseointegration was not assessed in this model. This design concept warrants further translational investigation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"616352"},"PeriodicalIF":1.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13616175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070328","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":"Evolution of Radiofrequency Transseptal Puncture Devices.","authors":"Rui Wang, Chunying Jiang","doi":"10.2147/MDER.S635887","DOIUrl":"10.2147/MDER.S635887","url":null,"abstract":"<p><p>Transseptal puncture (TSP) is an indispensable step for establishing left atrial access and plays a pivotal role in complex left-heart interventions, including catheter ablation for atrial fibrillation, left atrial appendage occlusion, and transcatheter mitral valve therapy. As such, TSP ranks among the core techniques in contemporary cardiovascular interventional cardiology. Since its first description in the 1950s, TSP tools have undergone decades of iterative refinement, evolving from conventional mechanical needles to diverse energy-assisted puncture systems. The performance of a TSP system directly determines procedural success, safety, and patient prognosis. This article systematically reviews the developmental history of TSP devices, with a focused overview of the developmental background, technical evolution, clinical applications, and advantages of radiofrequency-based puncture devices (including radiofrequency guidewires and radiofrequency needles), and briefly outlines future directions for innovation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"635887"},"PeriodicalIF":1.5,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064534","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":"Comparison of Gentleness and Reapplication Between Two Pulse Oximetry Probes in Healthy Adults in a Laboratory Setting.","authors":"Gary Grove, Timothy Houser, Jacob Dove, Derek Moody","doi":"10.2147/MDER.S619831","DOIUrl":"10.2147/MDER.S619831","url":null,"abstract":"<p><strong>Purpose: </strong>Many commonly used monitoring devices use adhesives to attach to the skin. These devices can cause avoidable skin damage, known as medical adhesive-related skin injury (MARSI). Pulse oximetry is a ubiquitous medical device used throughout care settings and, depending on the type of care, may have wear times over many hours or days. The purpose of these studies was to compare gentleness and reapplication of two pulse oximetry probes (Nellcor™ OxySoft™ neonatal-adult SpO₂ sensor, Medtronic (silicone-based probe); LNCS^® Neo, Masimo^® (acrylic-based probe)).</p><p><strong>Patients and methods: </strong>Institutional Review Board approval was obtained prior to study initiation and all participants provided informed consent prior to commencement of study procedures. Eighteen participants were enrolled in the gentleness trial and 19 participants were enrolled in the reapplication trial. For the gentleness trial, Trans-Epidermal Water Loss (TEWL) measurements were made at five sites on the forearm at three time points (baseline (T0), 4-hours post-initial wear (T1), 4-hours post-second wear (T2)). The total amount of protein adhered to each device was determined. For the reapplication trial, a series of 180° peel tests from the forearm were performed.</p><p><strong>Results: </strong>For the gentleness trial, no significant differences in TEWL rates were noted between the two probes at any time point. When examining protein removal, the silicone-based probe removed approximately 75% less protein compared to the acrylic-based probe. For the reapplication trial, the silicone-based probe retained approximately 85% of initial peel-force retention after 18 reapplications, whereas after only two reapplications the acrylic-based probe retained approximately 50% of initial peel-force retention.</p><p><strong>Conclusion: </strong>In healthy adults in a laboratory setting both probes appeared to be gentle on skin. The silicone-based probe demonstrated the ability to withstand 18 reapplications without functional loss in adhesion.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"619831"},"PeriodicalIF":1.5,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13588249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149008886","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 Silver-Zeolite Spray Powder for Pressure Ulcers and Minor Burns: Real-World Evidence from Primary Care.","authors":"Lorel Mureșan, Dionisio Franco Barattini, Laura Simona Ianoși, Carlo Signorini, Rawia Harb","doi":"10.2147/MDER.S622994","DOIUrl":"10.2147/MDER.S622994","url":null,"abstract":"<p><strong>Background: </strong>Pressure ulcers and minor burns are commonly managed in primary care. The tested device is an adsorbing spray powder combining ionic silver (2.5%) and micronized zeolite (97.5%), designed to provide exudate control and antimicrobial activity in a topical formulation.</p><p><strong>Materials and methods: </strong>In this multicenter, open-label, single-arm post-market clinical follow-up (PMCF) study, adult outpatients with chronic stage II-III pressure ulcers (NPUAP) unhealed after ≥3 weeks of standard care, or with superficial/partial-thickness burns (<10% body surface area) within 48 hours of injury, received the tested product for 4 weeks. Co-primary endpoints were 4-week changes in PUSH (pressure ulcers) and Vancouver Scar Scale (VSS; burns) scores; secondary endpoints included pain (100-mm Visual Analog Scale), patient satisfaction, Investigator Global Assessment of Performance, and safety.</p><p><strong>Results: </strong>Fifty-eight patients were enrolled and 56 analyzed per-protocol (32 burns, 24 pressure ulcers); two discontinued for reasons unrelated to safety. At Week 4, 96.4% (54/56) showed meaningful improvement and none worsened. Mean VSS decreased from 5.22±2.78 to 1.31±1.49 in burns (p<0.001; bias-corrected d_avg=1.72), and mean PUSH decreased from 11.67±2.41 to 3.29±1.60 in pressure ulcers (p<0.001; bias-corrected d_avg=4.01), with 95.8% of pressure-ulcer patients achieving a ≥5-point reduction. VAS pain decreased from Week 2 in both subgroups (p<0.001). At Week 4, the Investigator considered 68.8% of burns and 29.2% of pressure ulcers healed. Patient satisfaction was high (75.0% very satisfied, 25.0% satisfied); no adverse events, device effects or deficiencies were reported.</p><p><strong>Conclusion: </strong>In this single-arm, real-world study, the tested device showed a favorable performance and safety signal in mild-to-moderate pressure ulcers and minor burns; given the non-comparative design, these findings do not establish equivalence or superiority to other silver-based dressings. Ease of use may support outpatient self-managed care; adequately powered randomized trials versus alternative silver-based dressings are warranted to confirm these findings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05649332.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"622994"},"PeriodicalIF":1.5,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13589787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012999","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 Prospective, Multi-Center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Two Absorbable Barbed Sutures in Thyroid Surgery.","authors":"Xiuhe Zou, Ting Zhang, Wenxin Zhao, Yijun Wu, Wei Wei, Xiubo Lu, Changsheng Teng, Tao Huang, Meiping Shen, Niels-Derrek Schmitz, Bogdan Ilie, Shun Qu, Hao Zhang","doi":"10.2147/MDER.S618906","DOIUrl":"10.2147/MDER.S618906","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate the safety and effectiveness of two types of absorbable barbed sutures, STRATAFIX^TM Spiral PDS^TM Plus and STRATAFIX^TM Spiral MONOCRYL^TM Plus, compared with traditional sutures made of the same material in the suturing of thyroid surgery incision.</p><p><strong>Patients and methods: </strong>This study was a multicenter, prospective, evaluator-blinded, three-arm, non-inferiority, randomized controlled design study with a planned enrollment of 501 patients undergoing open thyroid surgery. Subjects were randomized to Spiral PDS Plus group, Spiral MONOCRYL Plus group, or the control group, according to the allocation ratio of 1:1:1. The primary endpoint was the success rate of subjects achieving grade A healing of surgical incisions 5-7 days after surgery.</p><p><strong>Results: </strong>A total of 500 subjects were randomized in this study. The PP analysis was considered the primary analysis, while the FAS analysis was considered supportive. In the PPset, which included 154 subjects in Spiral PDS Plus group, 157 subjects in Spiral MONOCRYL Plus group, and 156 subjects in the control group, the grade A wound healing success rates were 99.4%, 98.7%, and 99.4%, respectively. The differences [Wald 95% CI] in success percentage between the two investigation groups and the control group were -0.01% [-1.79%, 1.77%] and -0.63% [-2.79%, 1.52%], respectively. Both Spiral PDS Plus and Spiral MONOCRYL Plus were found to be non-inferior to control in achieving Grade A healing of surgical incision (0.05 margin, p < 0.0001 for both).</p><p><strong>Conclusion: </strong>This study demonstrated the short-term safety and efficacy outcomes of using STRATAFIX^TM Spiral PDS^TM Plus and STRATAFIX^TM Spiral MONOCRYL^TM Plus sutures in the suturing of thyroid surgery incision, with acceptable risk-benefit.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"618906"},"PeriodicalIF":1.5,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13546646/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148901342","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":"Research on Collaborative Management of Disinfection Supply Center and Operating Room Consumables Based on Information Ecology Theory.","authors":"Shaojun Su, Jie Yang, Lina Bai, Yunfei Xu","doi":"10.2147/MDER.S634452","DOIUrl":"10.2147/MDER.S634452","url":null,"abstract":"<p><strong>Background: </strong>The coordination gap between the Central Sterile Supply Department (CSSD) and the Operating Room (OR) in surgical consumables management has become a bottleneck constraining surgical turnover and patient safety, yet existing digital implementations remain largely fragmented.</p><p><strong>Objective: </strong>This study aims to propose a conceptual framework for CSSD-OR consumable collaborative management based on information ecology theory, and to synthesize the integration pathways of key digital technologies.</p><p><strong>Methods: </strong>Using information ecology theory as the analytical framework (encompassing information, technology, human actors, and environment), this paper synthesizes the current literature on UDI, RFID, SPD models, data middleware, machine learning, and blockchain technologies in the CSSD-OR context. An integrated analytical framework is constructed by incorporating supply chain integration theory and socio-technical systems theory.</p><p><strong>Results: </strong>Information chain ruptures were identified at three critical nodes: distribution-receiving, usage-billing, and recycling-reprocessing. A three-tier analytical framework is proposed, comprising a foundation layer (information chain integration), an intermediate layer (technology-process adaptation), and a guarantee layer (institutional-performance synergy). The \"collection-transmission-processing-feedback\" closed-loop mechanism is conceptualized as the core operational logic linking material flows, risk warning, and responsibility traceability.</p><p><strong>Conclusion: </strong>The digital transformation of CSSD-OR consumable management requires systematic restoration of information ecosystem imbalances rather than isolated technology deployment. The proposed framework offers a theoretical reference for hospitals seeking to move beyond technology stacking toward ecological collaboration, particularly within the Chinese healthcare context where UDI mandates and DRG/DIP reforms are ongoing.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"634452"},"PeriodicalIF":1.5,"publicationDate":"2026-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13537172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148882161","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":"Effects of Mechanical Nasal Stimulation on Olfaction.","authors":"Jim Bartley, Luca Garbelli, Imran Amjad, David E White","doi":"10.2147/MDER.S626058","DOIUrl":"10.2147/MDER.S626058","url":null,"abstract":"<p><strong>Purpose: </strong>Experimental studies have shown that the olfactory sensory receptor neurons not only identify odors and assess odor concentrations, but also act as respiratory mechanical sensors that respond to nasal airflow during breathing. Both odor detection and mechanical sensing appear mediated by a shared cellular mechanism. This prospective, single-arm, uncontrolled, pilot study was conducted to ascertain whether olfactory nerve mechanical stimulation provided by a nasal breathing oscillation device (Goodair Nosebuds) could influence olfaction when olfaction was assessed objectively. The study was performed on participants, who felt that their olfaction could be improved.</p><p><strong>Methods: </strong>Participants wore a nasal breathing oscillation device (Goodair Nosebuds) ten minutes twice a day for four weeks. At the beginning of the study and after four weeks, the participants' olfaction was assessed. Olfactory testing was performed using Sniffin' Sticks (phenyl ethyl alcohol threshold, odor discrimination and odor identification).</p><p><strong>Results: </strong>After four weeks, participants using the nasal breathing oscillation device (Goodair Nosebuds), had an increase in olfactory function in phenyl ethyl alcohol threshold, and odor identification when compared to baseline. The global olfactory score (the sum of the three scores) increased.</p><p><strong>Conclusion: </strong>This prospective, single-arm, uncontrolled, pilot study indicates that olfactory nerve mechanical stimulation was associated with an improvement in olfactory scores.</p><p><strong>Trial registration: </strong>The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12625001131448).</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"626058"},"PeriodicalIF":1.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13528655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867191","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}