{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T15:44:50Z","timestamp":1782920690598,"version":"3.54.5"},"reference-count":46,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T00:00:00Z","timestamp":1676851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Federal Ministry of Education","award":["03ZZ0928L"],"award-info":[{"award-number":["03ZZ0928L"]}]},{"name":"Federal Ministry of Education","award":["03ZZ0928C"],"award-info":[{"award-number":["03ZZ0928C"]}]},{"name":"Research of Germany (BMBF)","award":["03ZZ0928L"],"award-info":[{"award-number":["03ZZ0928L"]}]},{"name":"Research of Germany (BMBF)","award":["03ZZ0928C"],"award-info":[{"award-number":["03ZZ0928C"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Imaging"],"abstract":"<jats:p>The aim of this study was to develop and validate a semi-automated segmentation approach that identifies the round window niche (RWN) and round window membrane (RWM) for use in the development of patient individualized round window niche implants (RNI) to treat inner ear disorders. Twenty cone beam computed tomography (CBCT) datasets of unilateral temporal bones of patients were included in the study. Defined anatomical landmarks such as the RWM were used to develop a customized 3D Slicer\u2122 plugin for semi-automated segmentation of the RWN. Two otolaryngologists (User 1 and User 2) segmented the datasets manually and semi-automatically using the developed software. Both methods were compared in-silico regarding the resulting RWM area and RWN volume. Finally, the developed software was validated ex-vivo in N = 3 body donor implantation tests with additively manufactured RNI. The independently segmented temporal bones of the different Users showed a strong consistency in the volume of the RWN and the area of the RWM. The volume of the semi-automated RWN segmentations were 48 \u00b1 11% smaller on average than the manual segmentations and the area of the RWM of the semi-automated segmentations was 21 \u00b1 17% smaller on average than the manual segmentation. All additively manufactured implants, based on the semi-automated segmentation method could be implanted successfully in a pressure-tight fit into the RWN. The implants based on the manual segmentations failed to fit into the RWN and this suggests that the larger manual segmentations were over-segmentations. This study presents a semi-automated approach for segmenting the RWN and RWM in temporal bone CBCT scans that is efficient, fast, accurate, and not dependent on trained users. In addition, the manual segmentation, often positioned as the gold-standard, actually failed to pass the implantation validation.<\/jats:p>","DOI":"10.3390\/jimaging9020051","type":"journal-article","created":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T04:58:23Z","timestamp":1676869103000},"page":"51","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Development and In-Silico and Ex-Vivo Validation of a Software for a Semi-Automated Segmentation of the Round Window Niche to Design a Patient Specific Implant to Treat Inner Ear Disorders"],"prefix":"10.3390","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3953-112X","authenticated-orcid":false,"given":"Farnaz","family":"Matin-Mann","sequence":"first","affiliation":[{"name":"Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Department of Otorhinolaryngology, Head and Neck Surgery, Hannover Medical School, Stadtfelddamm 34, 30625 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9565-8838","authenticated-orcid":false,"given":"Ziwen","family":"Gao","sequence":"additional","affiliation":[{"name":"Cluster of Excellence \u201cHearing4all\u201d EXC 1077\/1, 30625 Hanover, Germany"},{"name":"Ear Nose and Throat Institute and Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai 200031, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunjiang","family":"Wei","sequence":"additional","affiliation":[{"name":"Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Department of Otorhinolaryngology, Head and Neck Surgery, Hannover Medical School, Stadtfelddamm 34, 30625 Hannover, Germany"},{"name":"Cluster of Excellence \u201cHearing4all\u201d EXC 1077\/1, 30625 Hanover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Repp","sequence":"additional","affiliation":[{"name":"OtoJig GmbH, Karl-Wiechert-Allee 3, 30625 Hanover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eralp-Niyazi","family":"Artukarslan","sequence":"additional","affiliation":[{"name":"Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Department of Otorhinolaryngology, Head and Neck Surgery, Hannover Medical School, Stadtfelddamm 34, 30625 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1509-0585","authenticated-orcid":false,"given":"Samuel","family":"John","sequence":"additional","affiliation":[{"name":"Ho\u0308rSys GmbH, Karl-Wiechert-Allee 3, 30625 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorian","family":"Alcacer Labrador","sequence":"additional","affiliation":[{"name":"Ho\u0308rSys GmbH, Karl-Wiechert-Allee 3, 30625 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9307-5989","authenticated-orcid":false,"given":"Thomas","family":"Lenarz","sequence":"additional","affiliation":[{"name":"Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Department of Otorhinolaryngology, Head and Neck Surgery, Hannover Medical School, Stadtfelddamm 34, 30625 Hannover, Germany"},{"name":"Cluster of Excellence \u201cHearing4all\u201d EXC 1077\/1, 30625 Hanover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8618-8793","authenticated-orcid":false,"given":"Verena","family":"Scheper","sequence":"additional","affiliation":[{"name":"Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Department of Otorhinolaryngology, Head and Neck Surgery, Hannover Medical School, Stadtfelddamm 34, 30625 Hannover, Germany"},{"name":"Cluster of Excellence \u201cHearing4all\u201d EXC 1077\/1, 30625 Hanover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,2,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1016\/j.jns.2016.01.029","article-title":"Bilateral simultaneous sudden sensorineural hearing loss","volume":"362","author":"Chen","year":"2016","journal-title":"J. Neurol Sci."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"S103","DOI":"10.1055\/s-0042-122385","article-title":"Diagnostik und Therapie des H\u00f6rsturzes","volume":"96","author":"Plontke","year":"2017","journal-title":"Laryngo-Rhino-Otologie"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"6059697","DOI":"10.1155\/2018\/6059697","article-title":"The Characteristic and Short-Term Prognosis of Tinnitus Associated with Sudden Sensorineural Hearing Loss","volume":"2018","author":"Ding","year":"2018","journal-title":"Neural Plast."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"490","DOI":"10.1177\/0003489419828759","article-title":"Intratympanic Steroid Use for Sudden Sensorineural Hearing Loss: Current Otolaryngology Practice","volume":"128","author":"Lechner","year":"2019","journal-title":"Ann. Otol. Rhinol. Laryngol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1007\/s00415-015-7930-1","article-title":"What is Meni\u00e8re\u2019s disease? A contemporary re-evaluation of endolymphatic hydrops","volume":"263","author":"Zou","year":"2016","journal-title":"J. Neurol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1159\/000475875","article-title":"Population-Based Study on the Epidemiology of M\u00e9ni\u00e8re\u2019s Disease","volume":"22","author":"Bruderer","year":"2017","journal-title":"Audiol. Neurotol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"122","DOI":"10.5152\/iao.2015.1227","article-title":"Recovery of Idiopathic Sudden Sensorineural Hearing Loss","volume":"11","author":"Edizer","year":"2015","journal-title":"J Int Adv Otol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"h6816","DOI":"10.1136\/bmj.h6816","article-title":"Efficacy and safety of betahistine treatment in patients with Meniere\u2019s disease: Primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial)","volume":"352","author":"Adrion","year":"2016","journal-title":"BMJ"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1007\/s00405-018-5260-5","article-title":"Clinical features and management of Meniere\u2019s disease patients with drop attacks","volume":"276","author":"Wu","year":"2019","journal-title":"Eur. Arch. Oto-Rhino-Laryngol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1111\/coa.12947","article-title":"Idiopathic sudden sensorineural hearing loss and meniere syndrome: The role of cerebral venous drainage","volume":"43","author":"Ciccone","year":"2018","journal-title":"Clin. Otolaryngol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1124","DOI":"10.1097\/MAO.0b013e31815aee21","article-title":"Intratympanic Versus Intravenous Delivery of Methylprednisolone to Cochlear Perilymph","volume":"28","author":"Bird","year":"2007","journal-title":"Otol. Neurotol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.joto.2017.06.002","article-title":"Intratympanic corticosteroids in M\u00e9ni\u00e8re\u2019s disease: A mini-review","volume":"12","author":"Patel","year":"2017","journal-title":"J. Otol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"739","DOI":"10.1109\/TIP.2020.3038363","article-title":"PWD-3DNet: A Deep Learning-Based Fully-Automated Segmentation of Multiple Structures on Temporal Bone CT Scans","volume":"30","author":"Nikan","year":"2021","journal-title":"IEEE Trans. Image Process."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1007\/s12105-018-0926-2","article-title":"Anatomy and Surgical Approach of the Ear and Temporal Bone","volume":"12","author":"Isaacson","year":"2018","journal-title":"Head Neck Pathol."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Matin, F., Gao, Z., Repp, F., John, S., Lenarz, T., and Scheper, V. (2021). Determination of the Round Window Niche Anatomy Using Cone Beam Computed Tomography Imaging as Preparatory Work for Individualized Drug-Releasing Implants. J. Imaging, 7.","DOI":"10.3390\/jimaging7050079"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1354","DOI":"10.1097\/MAO.0000000000000332","article-title":"Is the human round window really round? An anatomic study with surgical implications","volume":"35","author":"Atturo","year":"2014","journal-title":"Otol. Neurotol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1097\/mao.0b013e3180577949","article-title":"Anatomy of the round window and hook region of the cochlea with implications for cochlear implantation and other endocochlear surgical procedures","volume":"28","author":"Li","year":"2007","journal-title":"Otol. Neurotol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1002\/ca.22339","article-title":"Surgical anatomy of round window and its implications for cochlear implantation","volume":"27","author":"Singla","year":"2014","journal-title":"Clin. Anat."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1097\/MAO.0000000000002924","article-title":"A Micro-Computed Tomography Study of Round Window Anatomy and Implications for Atraumatic Cochlear Implant Insertion","volume":"42","author":"Cornwall","year":"2021","journal-title":"Otol. Neurotol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1097\/MAO.0b013e31819e61ed","article-title":"Automatic identification and 3D rendering of temporal bone anatomy","volume":"30","author":"Noble","year":"2009","journal-title":"Otol. Neurotol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"724","DOI":"10.1177\/0003489420970217","article-title":"Segmentation of Temporal Bone Anatomy for Patient-Specific Virtual Reality Simulation","volume":"130","author":"Andersen","year":"2021","journal-title":"Ann. Otol. Rhinol. Laryngol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1937","DOI":"10.1007\/s11548-017-1658-6","article-title":"Atlas-Based Segmentation of Temporal Bone Anatomy","volume":"12","author":"Powell","year":"2017","journal-title":"Int. J. Comput. Assist. Radiol. Surg."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1038\/s41598-020-80619-0","article-title":"Fully automated preoperative segmentation of temporal bone structures from clinical CT scans","volume":"11","author":"Neves","year":"2021","journal-title":"Sci. Rep."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1177\/000348940010900105","article-title":"Extraneous round window membranes and plugs: Possible effect on intratympanic therapy","volume":"109","author":"Alzamil","year":"2000","journal-title":"Ann. Owl. Rhinol. Laryngol."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Wang, J., Lv, Y., Wang, J., Ma, F., Du, Y., Fan, X., and Wang, M. (2021). Fully automated segmentation in temporal bone CT with neural network: A preliminary assessment study. BMC Med. Imaging, 21.","DOI":"10.1186\/s12880-021-00698-x"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"722","DOI":"10.1097\/MAO.0b013e3181d279e0","article-title":"Consensus Panel on a Cochlear Coordinate System Applicable in Histologic, Physiologic, and Radiologic Studies of the Human Cochlea","volume":"31","author":"Verbist","year":"2010","journal-title":"Otol. Neurotol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1323","DOI":"10.1016\/j.mri.2012.05.001","article-title":"3D Slicer as an image computing platform for the Quantitative Imaging Network","volume":"30","author":"Fedorov","year":"2012","journal-title":"Magn. Reson. Imaging"},{"key":"ref_28","unstructured":"(2022, June 01). Available online: https:\/\/docs.scipy.org\/doc\/scipy\/reference\/generated\/scipy.stats.pearsonr.html."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"846","DOI":"10.1001\/archotol.1993.01880200046007","article-title":"The National Temporal Bone, Hearing, and Balance Pathology Resource Registry","volume":"119","author":"Merchant","year":"1993","journal-title":"Arch. Otolaryngol. Head Neck Surg."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1111\/jmi.12507","article-title":"Micro-CT versus synchrotron radiation phase contrast imaging of human cochlea","volume":"265","author":"Elfarnawany","year":"2017","journal-title":"J. Microsc."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1251","DOI":"10.1097\/MAO.0000000000000405","article-title":"Individual computer-assisted 3D planning for surgical placement of a new bone conduction hearing device","volume":"35","author":"Plontke","year":"2014","journal-title":"Otol. Neurotol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1080\/00016489.2017.1278573","article-title":"Robotic cochlear implantation: Surgical procedure and first clinical experience","volume":"137","author":"Caversaccio","year":"2017","journal-title":"Acta Otolaryngol."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1186\/s40463-019-0324-0","article-title":"Morphological analysis of sigmoid sinus anatomy: Clinical applications to neurotological surgery","volume":"48","author":"Allen","year":"2019","journal-title":"J. Otolaryngol. Head Neck Surg."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1001\/jamaoto.2018.3096","article-title":"Association Between Flat-Panel Computed Tomographic Imaging-Guided Place-Pitch Mapping and Speech and Pitch Perception in Cochlear Implant Users","volume":"145","author":"Jiam","year":"2019","journal-title":"JAMA Otolaryngol. Head Neck Surg."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1016\/j.heares.2016.06.013","article-title":"Place dependent stimulation rates improve pitch perception in cochlear implantees with single-sided deafness","volume":"339","author":"Rader","year":"2016","journal-title":"Hear. Res."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"7500","DOI":"10.1038\/s41598-017-07795-4","article-title":"Spiral Form of the Human Cochlea Results from Spatial Constraints","volume":"7","author":"Pietsch","year":"2017","journal-title":"Sci. Rep."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"5590","DOI":"10.1118\/1.3634048","article-title":"Automatic segmentation of the facial nerve and chorda tympani in pediatric CT scans","volume":"38","author":"Reda","year":"2011","journal-title":"Med. Phys."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"2277","DOI":"10.1002\/lary.21104","article-title":"Anatomic verification of a novel method for precise intrascalar localization of cochlear implant electrodes in adult temporal bones using clinically available computed tomography","volume":"120","author":"Schuman","year":"2010","journal-title":"Laryngoscope"},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1007\/s11548-017-1701-7","article-title":"Patient-specific estimation of detailed cochlear shape from clinical CT images","volume":"13","author":"Kjer","year":"2018","journal-title":"Int. J. Comput. Assist. Radiol. Surg."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1007\/s11095-018-2454-x","article-title":"3D Printing in Pharmaceutical and Medical Applications-Recent Achievements and Challenges","volume":"35","author":"Jamroz","year":"2018","journal-title":"Pharm. Res."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"5340616","DOI":"10.1155\/2019\/5340616","article-title":"The Role of 3D Printing in Medical Applications: A State of the Art","volume":"2019","author":"Aimar","year":"2019","journal-title":"J. Healthc Eng."},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Domsta, V., and Seidlitz, A. (2021). 3D-Printing of Drug-Eluting Implants: An Overview of the Current Developments Described in the Literature. Molecules, 26.","DOI":"10.3390\/molecules26134066"},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Tan, D.K., Maniruzzaman, M., and Nokhodchi, A. (2018). Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery. Pharmaceutics, 10.","DOI":"10.3390\/pharmaceutics10040203"},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"685","DOI":"10.1080\/17434440.2017.1363647","article-title":"3D printed drug delivery devices: Perspectives and technical challenges","volume":"14","author":"Palo","year":"2017","journal-title":"Expert Rev. Med. Devices"},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"89","DOI":"10.2217\/3dp-2018-0012","article-title":"3D printing in dentistry","volume":"2","author":"Prasad","year":"2018","journal-title":"J. 3D Print. Med."},{"key":"ref_46","first-page":"4982","article-title":"Automated Registration-Based Temporal Bone Computed Tomography Segmentation for Applications in Neurotologic Surgery","volume":"167","author":"Ding","year":"2021","journal-title":"Otolaryngol. Head Neck Surg."}],"container-title":["Journal of Imaging"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2313-433X\/9\/2\/51\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T18:37:05Z","timestamp":1760121425000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2313-433X\/9\/2\/51"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,20]]},"references-count":46,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2023,2]]}},"alternative-id":["jimaging9020051"],"URL":"https:\/\/doi.org\/10.3390\/jimaging9020051","relation":{},"ISSN":["2313-433X"],"issn-type":[{"value":"2313-433X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,20]]}}}