Diagnosis of Tympanic Effusions Using Hyperspectral Imaging to Prevent Unnecessary Paracentesis Procedures

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It is commonly treated by tympanostomy tube placement. Diagnosis relies on clinical history, otoscopy, audiometry, and tympanometry, but these methods have a high false-positive rate of 15–28%. This highlights the need for an objective, reliable, and non-invasive diagnostic tool to reduce unnecessary surgeries. Methods To evaluate the rate of false-positive OME diagnoses in our tertiary hospital, a retrospective database analysis was conducted. To assess the feasibility of advanced imaging, experimental studies were performed on human body donors. Sodium chloride solution was intratympanically injected under endoscopic guidance. Hyperspectral imaging (HSI) datasets were acquired using a customized endoscopic system to quantify tissue water content. Results An analysis of hospital records identified a false positive rate of 29% (n = 4,564) for OME diagnosis, comparing the number of paracenteses to paracenteses plus tympanostomy tubes. In the ex vivo analysis of HSI, visual evaluation of the Tissue Water Index (TWI) demonstrated sensitivity, specificity, and accuracy of 89%, 78%, and 83%, respectively. The mean TWI of all evaluated tympanic membranes was 50.2 (± 7.1) before injection (control) and increased to 62.8 (± 14.8) after injection. Conclusion HSI presents a highly sensitive and user-friendly alternative for diagnosing OME. Its implementation could reduce unnecessary surgeries, minimizing patient burden and healthcare costs. Biomedical Engineering Otorhinolaryngology tympanostomy hyperspectral imaging otoscopy middle ear effusion otitis media with effusion tympanic membrane Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Background Otitis Media with Effusion (OME) is a prevalent condition in childhood, with an occurrence of up to 90% and the potential for recurrent episodes. In about 10% of cases, OME progresses to a chronic state, leading to complications such as tympanic membrane atrophy or retraction pockets. This condition typically arises from Eustachian tube dysfunction, which may result in biofilm formation that traps bacteria [ 1 ]. The resulting conductive hearing loss ranges between 10–40 dB. Diagnosis is based on clinical history, otoscopy, audiometry, and tympanometry. In English-speaking countries, pneumatic otoscopy is commonly used, whereas it is less emphasized in German-speaking regions. Diagnostic challenges, particularly in infants and young children, arise from the subjective nature of audiometry and variability in tympanometry results, with specificity ranging between 72–85% [ 2 ], [ 3 ], [ 4 ]. This translates to a false-positive rate of 15–28%, which may be influenced by narrow ear canals, cerumen, or patient non-compliance. Additionally, accurate otoscopic evaluation is often challenging in this population due to anatomical and behavioral factors. In addition to visual inspection, more advanced optical methods for the diagnosis of OME have also been investigated. Optical coherence tomography (OCT) was used to obtain cross-sectional images of the tympanic membrane. This morphological information was automatically classified as normal or OME using machine learning methods [ 5 ]. The first study using spectroscopy in the visible and near-infrared range for OME diagnosis proved its feasibility in 258 patients and reported the significance of the water absorption peak at 970 nm [ 6 ]. Since water absorbs light more strongly above 1000 nm, consequently several studies have also investigated the shortwave infrared (SWIR) range from 1000 to 1700 nm for imaging of fluid in the middle ear [ 7 ], [ 8 ]. Carr et al. measured the absorption spectrum of human middle ear fluid ex vivo and demonstrated that the main absorption peaks are based on water as the major chromophore [ 8 ]. An overview of various optical and acoustic methods used in clinical studies for the detection of middle ear infections, along with their performance, can be found in Prasad et al. [ 9 ]. More recently, autofluorescence of the tympanic membrane was investigated for OME diagnosis using ultraviolet (UV) LEDs in combination with a smartphone-based otoscope and machine learning [ 10 ]. Raman spectroscopy has also been explored for otoscopic applications. However, its clinical use remains impractical due to the complexity of the analytical method and its limited penetration depth [ 11 ]. A highly advanced non-invasive imaging technique has also been applied to this question. Several research groups have demonstrated the detection of middle ear effusions using ultrasound. Notably, Seth et al. [ 12 ] showed that effusions could be detected through a water-filled ear canal in 94% of cases. However, they emphasized that this approach is not practically feasible in awake children. Chen et al. [ 13 ] explored the possibility of estimating middle ear fluid characteristics using transmastoid ultrasound. The study suggests that the method can assess middle ear effusion via mastoid ultrasound, but its accuracy is limited. No effective conservative treatment exists for OME [ 14 ]. Current management options include watchful waiting, often combined with nasal balloon therapy, or surgical intervention. German clinical guidelines regarding OME (Status of 2018) recommend myringotomy and tympanostomy tube placement for children with persistent effusions (> 3 months) and hearing impairment [ 15 ]. Adenoidectomy combined with tympanostomy has shown the best outcomes in improving hearing thresholds [ 16 ]. Surgical treatment must consider the potential for permanent tympanic membrane alterations following tympanostomy tube placement. Additionally, therapy-resistant otorrhea may occur. To prevent otorrhea, the use of earplugs is recommended [ 17 ], [ 18 ]. Untreated OME can lead to structural changes of the tympanic membrane, including retraction pockets, ossicular erosion, and cholesteatoma, as well as developmental delays in speech and behavior [ 19 ], [ 20 ], [ 21 ]. Histopathological changes to the tympanic membrane may also result in altered elasticity of the tympanic membrane [ 22 ]. A practical challenge in clinical practice is the latency between diagnosis and surgery. Given OME's tendency for spontaneous resolution, patients may present without effusion on the day of surgery, leading to unnecessary procedures. From both medical and economic perspectives, there is a pressing need for an objective, reliable, and non-invasive diagnostic tool to improve preoperative accuracy. Such a tool should be reproducible, cost-effective, and simple to implement. Its ultimate goal would be to reduce the number of unnecessary myringotomies by ensuring the presence of OME before surgery. Spectral imaging could meet these requirements. This method combines two standard techniques, spectroscopy and digital imaging, in a single device. The resulting image data contains information from multiple distinct wavelength ranges in each pixel. Depending on the method used, these spectral channels can also cover the non-visible range of light and be used for chemometric analysis of tissue, such as determining hemoglobin content. Therefore, this study aims to demonstrate for the first time the technical feasibility of near-infrared hyperspectral imaging of the tympanic membrane for the detection of intratympanic fluid. Methods In order to assess the need for a further diagnostic tool for the diagnosis of OME, we analysed the rate of paracentesis without insertion of a tympanostomy tube (OPS code 5-200.4) for the diagnoses (according to ICD-10) H65.2, H65.3, H65.4, H65.9, H68.0, H68.1, H69.8, and H69.9. This analysis aimed to determine the false-positive rate in diagnosing OME, as evidenced by cases where paracentesis was performed without subsequent tympanostomy tube insertion. As a further OPS code, the number 5-200.5 (paracentesis with insertion of a tympanostomy tube) was searched for in order to compare with the rate of tympanostomy tube insertions performed. The data from our internal hospital database system SAP from 2012 to 2024 was analysed. In total we analysed 4,564 patients with an age range from 0 to 94 years and a median age of 3 years. All indications for tympanostomy are based on clinical history, medical examination, and tympanometry. The technical anatomical examinations were carried out on six human body donors (Table 1 ). These body donors were stored at a temperature of 4°C in the Institute of Anatomy at the Leipzig Faculty of Medicine. All body donors had given their informed consent to donate their bodies for research and teaching purposes before their passing. The experimental protocols were approved by the Ethics Committee of the Medical Faculty of the University of Leipzig (129/21-ck). This study was conducted according to the Declaration of Helsinki. Table 1 Data of the human body donors Body donor ID Age in years BMI Sex Conservation Days from death to measurement Ears included 01 73 33.8 m cold storage 3 Right 02 87 28.7 m cold storage 8 Left + Right 03 85 33.4 m cold storage 1 Right 04 89 25.6 m cold storage 3 Right 05 89 15.9 m cold storage 3 Left + Right 06 66 26.4 f cold storage 4 Left + Right An intratympanic injection of 0.9% sodium chloride solution was performed using a 1 ml tuberculin syringe and an ultra-thin cannula with an oblique cut and a length of 90 mm with an outer diameter of 0.4 mm, 27G (Mediplast AB, Malmö, Sweden) in the sense of an intratympanic fluid injection. This cannula was slightly curved at the base to keep the surgeon's view clear. The injection was made into the anterior or posterior upper quadrant of the tympanic membrane to prevent the injection fluid from leaking as well as possible (Fig. 1 ). Beforehand, the ear canal was cleaned if it was blocked with cerumen. The puncture was performed under endoscopic vision. We used a HOPKINS Telescope 0° optic, ICG, 4 mm (28164AC, Karl Storz SE & Co. KG, Tuttlingen, Germany) as endoscope. Up to 0.5 ml of fluid was gradually injected into the tympanic cavity and a measurement was taken. Hyperspectral Imaging and Data Analysis The tympanic membrane visualization and the acquisition of hyperspectral measurement data were performed with a customized laboratory version of the TIVITA® Mini system (Diaspective Vision GmbH, Am Salzhaff-Pepelow, Germany) [ 23 ], which is currently not available for use with 4 mm endoscopes. The device used enables the simultaneous display of a color video and the recording of spatially resolved spectra in the visible and near-infrared range (500 to 995 nm, 5 nm steps). The method used for spectral data recording was push-broom scanning, which required a recording time of seven seconds and resulted in an image size of 720 x 540 pixels. During scanning, the camera should be held as stable as possible to avoid motion artifacts. An integrated broadband LED light source was used to illuminate the object. The emitted light undergoes specific absorption, scattering, and reflection processes in biological tissue, which lead to spectral changes that can be measured using hyperspectral imaging. The dominant chromophores are oxygenated and deoxygenated hemoglobin. Due to their different light absorption at specific wavelengths, the oxygen saturation of the observed tissue can be determined at each pixel of the image. Although water absorbs light only slightly in the observed spectral range, the local absorption maximum around 970 nm can be used to visualize the spatial distribution of the relative water content of the tissue. A calculation provided by the device manufacturer as referenced in Holmer et al. [ 24 ] was used to quantify tissue water content. This derived parameter is referred to as the Tissue Water Index (TWI) with a value range from 0 to 100 and can be visualized using a color map. The tympanic membrane was annotated in the reconstructed color image derived from the spectral data of each record for the statistical analysis of the TWI after the procedure. Based on this region of interest (ROI), the TWI distributions for each tympanic membrane before (Control) and after fluid injection were investigated. Furthermore, the mean TWI for each ROI was calculated and the distribution over all investigated ears, as well as the Delta TWI (After injection - Control), were analyzed in terms of median and quartiles. Statistical analysis and data visualization were performed using Python (v3.10) with Pandas (v1.5) and Seaborn (v0.11) library. Results Statistical Analysis of OME-related operations From 2012 to 2024 (13 years), a total of 4564 operations (OPS 5-200.4 and OPS 5-200.5) were performed with the ICD-10 codes H65.2, H65.3, H65.4, H65.9, H68.0, H68.1, H69.8 and H69.9. Of these, the vast majority of cases were in the age cohort 1–5 years (Fig. 2 ). A tympanostomy tube insertion was performed in a total of 3,236 cases (71%) and was omitted in 1,328 cases (29%). This results in a total of 102 paracentesis without tympanostomy tube insertion per year. In the age cohort 1–5 years, this results in an average annual number of 248 operations, with tympanostomy tube placed in 168 times and omitted in 80 times. An exception is the years 2020 and 2021, in which fewer operations were performed due to COVID-19 pandemic restrictions (Fig. 3 ). This results in a relatively stable rate of approx. 68% probability for the insertion of a tympanostomy tube in this age cohort, given a clinical indication. HSI of Tympanic Membranes in Body Donors Measurements were carried out on a total of six body donors. One tympanic membrane had to be excluded before the measurement due to a rupture (04L). In two others, water leaked from the injection site (01L and 03L). Therefore, three tympanic membranes had to be excluded and nine were evaluated. The reconstructed color images and TWI maps before and after injection are shown in Fig. 4 for two cases. In addition, this figure illustrates the mean normalized reflectance spectra for these tympanic membranes. The spectral curves clearly show a drop in reflectance at 760 nm, which is caused by the absorption peak of deoxygenated hemoglobin. After the injection, the reflectance spectra show a reduction in the signal at 970 nm, which indicates a higher water content and leads to the increase in the local TWI shown. A graphical representation of the pixel-wise TWI distributions for each evaluated tympanic membrane can be found in Fig. 5 A. In one case (01R), no increase in TWI was observed after injection, while in another case (04R), an increase was seen only in a small area of the tympanic membrane. The visual assessment of TWI spatial distribution by the surgeon was evaluated, as this corresponds to the clinical use case. The resulting metrics of sensitivity, specificity, and accuracy were 89%, 78%, and 83%, respectively. The mean TWI of all evaluated tympanic membranes before injection (Control) was 50.2 (± 7.1) and after injection 62.8 (± 14.8). An average TWI change (Delta TWI = After injection - Control) of 12.6 (± 11.1) was observed (Fig. 5 B). Discussion Our analysis of the hospital's internal database shows that a therapeutic tympanostomy is performed in approximately two out of three cases of OME. On average, 351 surgeries are conducted annually for this indication, with tympanostomy tubes placed in 249 patients, while 102 cases do not undergo this procedure. This results in a 71% likelihood that the indicated therapy is carried out. Consequently, a discrepancy of 29% remains, corresponding to approximately 100 cases per year in a German tertiary care hospital where the indicated therapy is not required. Comparisons with other major hospitals are challenging due to the lack of published data; a PubMed search does not yield comparable studies. In fact, the reported accuracy of diagnosing acute otitis media, a related condition, ranges from 58–73% in the literature [ 6 ], [ 25 ], [ 26 ]. The indication for tympanostomy is primarily based on anamnesis, clinical evaluation, tympanometry, and audiometry. However, audiometric assessments in infants and young children often rely on estimations, as brainstem-evoked response audiometry (BERA) is not routinely performed. As mentioned in the introduction, tympanometry shows widely varying sensitivity values, ranging from 72% to 85% [ 2 ], [ 3 ], [ 4 ], [ 27 ], [ 28 ]. This roughly correlates with the findings from our database query on the rate of true-positive middle ear effusions. A relevant non-invasive diagnostic alternative would be the use of an HSI camera, as demonstrated in our measurements, where we achieved a sensitivity of 89%. Since the technical conditions were consistently the same, failures in the tests are more likely to be attributed to inherent test errors. These could be caused by improper injection or drainage of the test fluid (0.9% NaCl), which, unlike middle ear effusion, is not mucous and very viscous but rather fluid (serous). This fluid may have been drained through the Eustachian tube before measurement or may have pooled in the epitympanum. Digital otoscopy has gained in popularity over the past few decades, but it does not appear to offer any significant diagnostic advantage over traditional otoscopy in identifying effusions [ 29 ], [ 30 ]. This limitation is likely due to the constraints of visible light illumination and the inherent variability in human interpretation of the captured images. Preliminary research on this issue has already been conducted. For example, Schmilovitch’s group utilized an otoscope integrated with a spectrometer in the same wavelength range as this work, achieving high sensitivity and specificity in diagnosing otitis media. However, it is important to note that the diagnostic accuracy in this case was based on the subjective judgment of the examining physician as the gold standard, with no paracentesis performed to verify the diagnosis, which limits the reliability of the findings [ 6 ]. Monroy’s group explored the use of optical coherence tomography (OCT) to diagnose both acute and chronic otitis media, focusing particularly on evaluating the presence of a biofilm. As in the previous case, the gold standard for diagnosis was the indirect otoscopic assessment, which further weakens the robustness of the results [ 5 ]. More recently, Preciado and colleagues developed a prototype OCT otoscope that demonstrated promising results, with a sensitivity of 90.9% and specificity of 90.2%, and the ability to distinguish mucoid from serous effusions [ 31 ]. However, as with other otoscopy modalities, a significant challenge remains: variability in user operation and interpretation. Ultrasound has been extensively studied for detecting middle ear effusion. Filling the ear canal with water to enhance wave transmission has achieved a 94% detection rate [ 12 ]. But this approach is impractical in awake children, as water instillation may trigger vestibular symptoms by stimulating the horizontal semicircular canal. Another study investigated the detection of middle ear effusion using transmastoid ultrasound. The method was able to distinguish composition differences of middle ear fluid. However, it is highly operator-dependent, and variations in the scalp or mastoid anatomy may lead to inaccurate results. While promising, this technique requires further investigation [ 13 ]. The HSI technique could provide an interesting complement, as it is operator-independent and does not induce vertigo. Although it requires a very calm child as the patient. Combining both methods could potentially improve the detection accuracy. Two studies have also investigated the use of SWIR otoscopes, achieving high sensitivity rates of up to 90% by applying Random Forest methods to predict OME based on the intensity distribution of the image [ 7 ], [ 8 ]. Despite these promising results, accurate differentiation between fluid-filled and air-filled middle ear cavities is highly dependent on the light intensity, e.g. due to the measuring distance, and the image output itself provides only limited diagnostic value. It is important to note that the reported SWIR otoscopes do not enable spectral differentiation, but record a single grey-scale image over a broad wavelength range. In contrast, HSI offers a high spectral resolution and thus the capability to calculate ratios between several wavelength ranges. This enables the compensation of external influences and allows distance-independent imaging of the water content. The primary limitations of this study include the use of NaCl as a solution, which does not match the viscosity of the mucous secretion found in middle ear effusions. This discrepancy may lead to a significantly faster drainage through the auditory tube into the nasopharynx. Additionally, the study was conducted exclusively on elderly body donors, limiting generalizability. Furthermore, the test group was relatively small; however, even within this limited cohort, significant results were obtained. Conclusions The current diagnostic approach for OME still has room for improvement. With false-positive rates reaching up to 30%, there is a clear need for more accurate diagnostic tools. HSI offers a highly sensitive and user-friendly quantification of intratympanic fluid. Its use could prevent unnecessary surgeries, sparing patients from unwarranted procedures while reducing financial strain on the healthcare system. Given our promising results with body donors, the next step is to validate these findings in clinical patient trials. Abbreviations OME Otitis Media with Effusion HSI Hyperspectral Imaging OCT Optical Coherence Tomography SWIR Shortwave Infrared TWI Tissue Water Index ROI Region Of Interest BERA Brainstem-Evoked Response Audiometry Declarations Ethics approval and consent to participate All body donors had given their informed consent to donate their bodies for research and teaching purposes before their passing. The experimental protocols were approved by the Ethics Committee of the Medical Faculty of the University of Leipzig (129/21-ck). This study was conducted according to the Declaration of Helsinki. Consent for publication Not applicable. Availability of data and materials The data is available from the corresponding author upon reasonable request. Competing interests The authors declare that they have no competing interests. Funding Open Access funding enabled and organized by Projekt DEAL. Authors’ contributions MG and HK wrote the initial draft, planned the experiments, and performed the data analysis. SL enabled the measurements on the body donors. MG, HK, DGB, and MU conducted the experiments. AD, AM, and MP supervised the project. All authors reviewed the final manuscript. Acknowledgements The authors would like to acknowledge technical support from KARL STORZ SE & Co. KG and Diaspective Vision GmbH. References Strutz J, Mann W (eds) (2010) Praxis der HNO-Heilkunde, Kopf- und Halschirurgie , 2., Vollständig überarbeitete und erweiterte Auflage. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9148677","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":607586862,"identity":"07043e37-50db-4e36-a5f8-644aa206a53b","order_by":0,"name":"Maximilian Gänzle","email":"data:image/png;base64,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","orcid":"","institution":"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Leipzig, Leipzig, Germany","correspondingAuthor":true,"prefix":"","firstName":"Maximilian","middleName":"","lastName":"Gänzle","suffix":""},{"id":607586863,"identity":"2997ba83-3998-462b-b8ce-b3689817ada8","order_by":1,"name":"Sabine Löffler","email":"","orcid":"","institution":"Institute of Anatomy, Faculty of Medicine, Leipzig University, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Sabine","middleName":"","lastName":"Löffler","suffix":""},{"id":607586864,"identity":"0b959f83-bdbd-4c21-a952-842abe4349af","order_by":2,"name":"Denis Gholami Bajestani","email":"","orcid":"","institution":"Innovation Center Computer Assisted Surgery (ICCAS), Faculty of Medicine, Leipzig University, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Denis","middleName":"Gholami","lastName":"Bajestani","suffix":""},{"id":607586865,"identity":"ba173002-0961-4813-a57a-11a8f0f7ec58","order_by":3,"name":"Michael Unger","email":"","orcid":"","institution":"Innovation Center Computer Assisted Surgery (ICCAS), Faculty of Medicine, Leipzig University, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"","lastName":"Unger","suffix":""},{"id":607586866,"identity":"03a8d5c8-a082-493c-8543-5c9fe31390d0","order_by":4,"name":"Andreas Dietz","email":"","orcid":"","institution":"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Leipzig, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Andreas","middleName":"","lastName":"Dietz","suffix":""},{"id":607586867,"identity":"eba4785d-5640-41c8-a16a-82f5b3575365","order_by":5,"name":"Andreas Melzer","email":"","orcid":"","institution":"Innovation Center Computer Assisted Surgery (ICCAS), Faculty of Medicine, Leipzig University, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Andreas","middleName":"","lastName":"Melzer","suffix":""},{"id":607586868,"identity":"d3429e81-e750-4fec-a13a-2ad96c6b0ff0","order_by":6,"name":"Markus Pirlich","email":"","orcid":"","institution":"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Leipzig, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Markus","middleName":"","lastName":"Pirlich","suffix":""},{"id":607586869,"identity":"c546091f-9171-4397-9fdf-a7cb25dae57f","order_by":7,"name":"Hannes Köhler","email":"","orcid":"","institution":"Innovation Center Computer Assisted Surgery (ICCAS), Faculty of Medicine, Leipzig University, Leipzig, Germany","correspondingAuthor":false,"prefix":"","firstName":"Hannes","middleName":"","lastName":"Köhler","suffix":""}],"badges":[],"createdAt":"2026-03-17 12:24:48","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-9148677/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9148677/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104879468,"identity":"ef0c1720-036c-408d-aabd-dc4497ed2ebc","added_by":"auto","created_at":"2026-03-18 09:02:39","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":524122,"visible":true,"origin":"","legend":"\u003cp\u003eExperimental setup with body donor (A), surgeon (B), endoscope (C) and screen with visualisation of tympanic membrane (*), ear canal (+) and injection cannula (#).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/722fd2cce3b073521e2fbe72.png"},{"id":104879469,"identity":"b4c84007-dcb2-4a35-964e-f4a7f09a4152","added_by":"auto","created_at":"2026-03-18 09:02:39","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":31966,"visible":true,"origin":"","legend":"\u003cp\u003eTotal number of OME cases (OPS 5-200.4 and 5-200.5) at our department from 2012 to 2024, grouped by patient age. The percentage of tympanic tubes inserted (OPS 5-200.5) is indicated above each bar.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/6c506401ba10004d48708d2e.png"},{"id":104879472,"identity":"1b00d577-86b3-4d13-88c7-3a4177a569dc","added_by":"auto","created_at":"2026-03-18 09:02:39","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":50023,"visible":true,"origin":"","legend":"\u003cp\u003eNumber of cases with OPS 5-200.4 or 5-200.5 and percentage of tympanic tubes inserted (second y-axis) in the 1-5 years age cohort at our department from 2012 to 2024.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/426fff330efabd4efdfe5ac9.png"},{"id":104879473,"identity":"699ae55e-108d-4f25-87d6-29ec685e5aa4","added_by":"auto","created_at":"2026-03-18 09:02:39","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":308581,"visible":true,"origin":"","legend":"\u003cp\u003eVisualization of intratympanic fluid. Left: Reconstructed color images from the tympanic membrane of body donors 02 (left ear) and 06 (left ear) with color maps representing spatial TWI distribution before (Control) and after injection. Right: Mean normalized reflectance spectra for the two tympanic membranes and both states.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/6904e0d937d9e4ce83b050e5.png"},{"id":104879471,"identity":"c001596e-efd9-404a-ae23-d700f5a682a3","added_by":"auto","created_at":"2026-03-18 09:02:39","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":87643,"visible":true,"origin":"","legend":"\u003cp\u003eStatistical analysis of all included ears (n=9) and measurements (n=18).\u003cstrong\u003e \u003c/strong\u003eDistribution of TWI values (pixel-wise) within each annotated ROI (\u003cstrong\u003eA\u003c/strong\u003e). Distributions of ROI means and TWI changes (Delta TWI = After injection - Control) per ear (\u003cstrong\u003eB\u003c/strong\u003e).\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/19fd50bf8cc92d2e425a9e62.png"},{"id":105034379,"identity":"6e6b92f4-e83f-4910-9552-8d4a67195451","added_by":"auto","created_at":"2026-03-20 07:23:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1704635,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9148677/v1/34284a17-7541-47f1-b597-49e5f0ee3d44.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eDiagnosis of Tympanic Effusions Using Hyperspectral Imaging to Prevent Unnecessary Paracentesis Procedures\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eOtitis Media with Effusion (OME) is a prevalent condition in childhood, with an occurrence of up to 90% and the potential for recurrent episodes. In about 10% of cases, OME progresses to a chronic state, leading to complications such as tympanic membrane atrophy or retraction pockets. This condition typically arises from Eustachian tube dysfunction, which may result in biofilm formation that traps bacteria [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The resulting conductive hearing loss ranges between 10\u0026ndash;40 dB.\u003c/p\u003e \u003cp\u003eDiagnosis is based on clinical history, otoscopy, audiometry, and tympanometry. In English-speaking countries, pneumatic otoscopy is commonly used, whereas it is less emphasized in German-speaking regions. Diagnostic challenges, particularly in infants and young children, arise from the subjective nature of audiometry and variability in tympanometry results, with specificity ranging between 72\u0026ndash;85% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. This translates to a false-positive rate of 15\u0026ndash;28%, which may be influenced by narrow ear canals, cerumen, or patient non-compliance. Additionally, accurate otoscopic evaluation is often challenging in this population due to anatomical and behavioral factors.\u003c/p\u003e \u003cp\u003eIn addition to visual inspection, more advanced optical methods for the diagnosis of OME have also been investigated. Optical coherence tomography (OCT) was used to obtain cross-sectional images of the tympanic membrane. This morphological information was automatically classified as normal or OME using machine learning methods [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The first study using spectroscopy in the visible and near-infrared range for OME diagnosis proved its feasibility in 258 patients and reported the significance of the water absorption peak at 970 nm [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Since water absorbs light more strongly above 1000 nm, consequently several studies have also investigated the shortwave infrared (SWIR) range from 1000 to 1700 nm for imaging of fluid in the middle ear [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Carr et al. measured the absorption spectrum of human middle ear fluid ex vivo and demonstrated that the main absorption peaks are based on water as the major chromophore [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. An overview of various optical and acoustic methods used in clinical studies for the detection of middle ear infections, along with their performance, can be found in Prasad et al. [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. More recently, autofluorescence of the tympanic membrane was investigated for OME diagnosis using ultraviolet (UV) LEDs in combination with a smartphone-based otoscope and machine learning [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Raman spectroscopy has also been explored for otoscopic applications. However, its clinical use remains impractical due to the complexity of the analytical method and its limited penetration depth [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. A highly advanced non-invasive imaging technique has also been applied to this question. Several research groups have demonstrated the detection of middle ear effusions using ultrasound. Notably, Seth et al. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] showed that effusions could be detected through a water-filled ear canal in 94% of cases. However, they emphasized that this approach is not practically feasible in awake children. Chen et al. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] explored the possibility of estimating middle ear fluid characteristics using transmastoid ultrasound. The study suggests that the method can assess middle ear effusion via mastoid ultrasound, but its accuracy is limited.\u003c/p\u003e \u003cp\u003eNo effective conservative treatment exists for OME [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Current management options include watchful waiting, often combined with nasal balloon therapy, or surgical intervention. German clinical guidelines regarding OME (Status of 2018) recommend myringotomy and tympanostomy tube placement for children with persistent effusions (\u0026gt;\u0026thinsp;3 months) and hearing impairment [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Adenoidectomy combined with tympanostomy has shown the best outcomes in improving hearing thresholds [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSurgical treatment must consider the potential for permanent tympanic membrane alterations following tympanostomy tube placement. Additionally, therapy-resistant otorrhea may occur. To prevent otorrhea, the use of earplugs is recommended [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Untreated OME can lead to structural changes of the tympanic membrane, including retraction pockets, ossicular erosion, and cholesteatoma, as well as developmental delays in speech and behavior [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e], [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Histopathological changes to the tympanic membrane may also result in altered elasticity of the tympanic membrane [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. A practical challenge in clinical practice is the latency between diagnosis and surgery. Given OME's tendency for spontaneous resolution, patients may present without effusion on the day of surgery, leading to unnecessary procedures.\u003c/p\u003e \u003cp\u003eFrom both medical and economic perspectives, there is a pressing need for an objective, reliable, and non-invasive diagnostic tool to improve preoperative accuracy. Such a tool should be reproducible, cost-effective, and simple to implement. Its ultimate goal would be to reduce the number of unnecessary myringotomies by ensuring the presence of OME before surgery.\u003c/p\u003e \u003cp\u003eSpectral imaging could meet these requirements. This method combines two standard techniques, spectroscopy and digital imaging, in a single device. The resulting image data contains information from multiple distinct wavelength ranges in each pixel. Depending on the method used, these spectral channels can also cover the non-visible range of light and be used for chemometric analysis of tissue, such as determining hemoglobin content. Therefore, this study aims to demonstrate for the first time the technical feasibility of near-infrared hyperspectral imaging of the tympanic membrane for the detection of intratympanic fluid.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eIn order to assess the need for a further diagnostic tool for the diagnosis of OME, we analysed the rate of paracentesis without insertion of a tympanostomy tube (OPS code 5-200.4) for the diagnoses (according to ICD-10) H65.2, H65.3, H65.4, H65.9, H68.0, H68.1, H69.8, and H69.9. This analysis aimed to determine the false-positive rate in diagnosing OME, as evidenced by cases where paracentesis was performed without subsequent tympanostomy tube insertion. As a further OPS code, the number 5-200.5 (paracentesis with insertion of a tympanostomy tube) was searched for in order to compare with the rate of tympanostomy tube insertions performed. The data from our internal hospital database system SAP from 2012 to 2024 was analysed. In total we analysed 4,564 patients with an age range from 0 to 94 years and a median age of 3 years. All indications for tympanostomy are based on clinical history, medical examination, and tympanometry.\u003c/p\u003e \u003cp\u003eThe technical anatomical examinations were carried out on six human body donors (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). These body donors were stored at a temperature of 4\u0026deg;C in the Institute of Anatomy at the Leipzig Faculty of Medicine. All body donors had given their informed consent to donate their bodies for research and teaching purposes before their passing. The experimental protocols were approved by the Ethics Committee of the Medical Faculty of the University of Leipzig (129/21-ck). This study was conducted according to the Declaration of Helsinki.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eData of the human body donors\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBody donor ID\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAge in years\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eConservation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eDays from death to measurement\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eEars included\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e73\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e33.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003em\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e28.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003em\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eLeft\u0026thinsp;+\u0026thinsp;Right\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e33.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003em\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e25.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003em\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003em\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eLeft\u0026thinsp;+\u0026thinsp;Right\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e26.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ef\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecold storage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eLeft\u0026thinsp;+\u0026thinsp;Right\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAn intratympanic injection of 0.9% sodium chloride solution was performed using a 1 ml tuberculin syringe and an ultra-thin cannula with an oblique cut and a length of 90 mm with an outer diameter of 0.4 mm, 27G (Mediplast AB, Malm\u0026ouml;, Sweden) in the sense of an intratympanic fluid injection. This cannula was slightly curved at the base to keep the surgeon's view clear. The injection was made into the anterior or posterior upper quadrant of the tympanic membrane to prevent the injection fluid from leaking as well as possible (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Beforehand, the ear canal was cleaned if it was blocked with cerumen. The puncture was performed under endoscopic vision. We used a HOPKINS Telescope 0\u0026deg; optic, ICG, 4 mm (28164AC, Karl Storz SE \u0026amp; Co. KG, Tuttlingen, Germany) as endoscope.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eUp to 0.5 ml of fluid was gradually injected into the tympanic cavity and a measurement was taken.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eHyperspectral Imaging and Data Analysis\u003c/h2\u003e \u003cp\u003eThe tympanic membrane visualization and the acquisition of hyperspectral measurement data were performed with a customized laboratory version of the TIVITA\u0026reg; Mini system (Diaspective Vision GmbH, Am Salzhaff-Pepelow, Germany) [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], which is currently not available for use with 4 mm endoscopes. The device used enables the simultaneous display of a color video and the recording of spatially resolved spectra in the visible and near-infrared range (500 to 995 nm, 5 nm steps). The method used for spectral data recording was push-broom scanning, which required a recording time of seven seconds and resulted in an image size of 720 x 540 pixels. During scanning, the camera should be held as stable as possible to avoid motion artifacts.\u003c/p\u003e \u003cp\u003eAn integrated broadband LED light source was used to illuminate the object. The emitted light undergoes specific absorption, scattering, and reflection processes in biological tissue, which lead to spectral changes that can be measured using hyperspectral imaging. The dominant chromophores are oxygenated and deoxygenated hemoglobin. Due to their different light absorption at specific wavelengths, the oxygen saturation of the observed tissue can be determined at each pixel of the image. Although water absorbs light only slightly in the observed spectral range, the local absorption maximum around 970 nm can be used to visualize the spatial distribution of the relative water content of the tissue. A calculation provided by the device manufacturer as referenced in Holmer et al. [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] was used to quantify tissue water content. This derived parameter is referred to as the Tissue Water Index (TWI) with a value range from 0 to 100 and can be visualized using a color map.\u003c/p\u003e \u003cp\u003eThe tympanic membrane was annotated in the reconstructed color image derived from the spectral data of each record for the statistical analysis of the TWI after the procedure. Based on this region of interest (ROI), the TWI distributions for each tympanic membrane before (Control) and after fluid injection were investigated. Furthermore, the mean TWI for each ROI was calculated and the distribution over all investigated ears, as well as the Delta TWI (After injection - Control), were analyzed in terms of median and quartiles. Statistical analysis and data visualization were performed using Python (v3.10) with Pandas (v1.5) and Seaborn (v0.11) library.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis of OME-related operations\u003c/h2\u003e \u003cp\u003eFrom 2012 to 2024 (13 years), a total of 4564 operations (OPS 5-200.4 and OPS 5-200.5) were performed with the ICD-10 codes H65.2, H65.3, H65.4, H65.9, H68.0, H68.1, H69.8 and H69.9. Of these, the vast majority of cases were in the age cohort 1\u0026ndash;5 years (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). A tympanostomy tube insertion was performed in a total of 3,236 cases (71%) and was omitted in 1,328 cases (29%). This results in a total of 102 paracentesis without tympanostomy tube insertion per year.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIn the age cohort 1\u0026ndash;5 years, this results in an average annual number of 248 operations, with tympanostomy tube placed in 168 times and omitted in 80 times. An exception is the years 2020 and 2021, in which fewer operations were performed due to COVID-19 pandemic restrictions (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). This results in a relatively stable rate of approx. 68% probability for the insertion of a tympanostomy tube in this age cohort, given a clinical indication.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eHSI of Tympanic Membranes in Body Donors\u003c/h3\u003e\n\u003cp\u003eMeasurements were carried out on a total of six body donors. One tympanic membrane had to be excluded before the measurement due to a rupture (04L). In two others, water leaked from the injection site (01L and 03L). Therefore, three tympanic membranes had to be excluded and nine were evaluated.\u003c/p\u003e \u003cp\u003eThe reconstructed color images and TWI maps before and after injection are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e for two cases. In addition, this figure illustrates the mean normalized reflectance spectra for these tympanic membranes. The spectral curves clearly show a drop in reflectance at 760 nm, which is caused by the absorption peak of deoxygenated hemoglobin. After the injection, the reflectance spectra show a reduction in the signal at 970 nm, which indicates a higher water content and leads to the increase in the local TWI shown.\u003c/p\u003e \u003cp\u003eA graphical representation of the pixel-wise TWI distributions for each evaluated tympanic membrane can be found in Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003eA. In one case (01R), no increase in TWI was observed after injection, while in another case (04R), an increase was seen only in a small area of the tympanic membrane. The visual assessment of TWI spatial distribution by the surgeon was evaluated, as this corresponds to the clinical use case. The resulting metrics of sensitivity, specificity, and accuracy were 89%, 78%, and 83%, respectively. The mean TWI of all evaluated tympanic membranes before injection (Control) was 50.2 (\u0026plusmn;\u0026thinsp;7.1) and after injection 62.8 (\u0026plusmn;\u0026thinsp;14.8). An average TWI change (Delta TWI\u0026thinsp;=\u0026thinsp;After injection - Control) of 12.6 (\u0026plusmn;\u0026thinsp;11.1) was observed (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003eB).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur analysis of the hospital's internal database shows that a therapeutic tympanostomy is performed in approximately two out of three cases of OME. On average, 351 surgeries are conducted annually for this indication, with tympanostomy tubes placed in 249 patients, while 102 cases do not undergo this procedure. This results in a 71% likelihood that the indicated therapy is carried out. Consequently, a discrepancy of 29% remains, corresponding to approximately 100 cases per year in a German tertiary care hospital where the indicated therapy is not required. Comparisons with other major hospitals are challenging due to the lack of published data; a PubMed search does not yield comparable studies. In fact, the reported accuracy of diagnosing acute otitis media, a related condition, ranges from 58\u0026ndash;73% in the literature [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe indication for tympanostomy is primarily based on anamnesis, clinical evaluation, tympanometry, and audiometry. However, audiometric assessments in infants and young children often rely on estimations, as brainstem-evoked response audiometry (BERA) is not routinely performed. As mentioned in the introduction, tympanometry shows widely varying sensitivity values, ranging from 72% to 85% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e], [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. This roughly correlates with the findings from our database query on the rate of true-positive middle ear effusions.\u003c/p\u003e \u003cp\u003eA relevant non-invasive diagnostic alternative would be the use of an HSI camera, as demonstrated in our measurements, where we achieved a sensitivity of 89%. Since the technical conditions were consistently the same, failures in the tests are more likely to be attributed to inherent test errors. These could be caused by improper injection or drainage of the test fluid (0.9% NaCl), which, unlike middle ear effusion, is not mucous and very viscous but rather fluid (serous). This fluid may have been drained through the Eustachian tube before measurement or may have pooled in the epitympanum.\u003c/p\u003e \u003cp\u003eDigital otoscopy has gained in popularity over the past few decades, but it does not appear to offer any significant diagnostic advantage over traditional otoscopy in identifying effusions [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. This limitation is likely due to the constraints of visible light illumination and the inherent variability in human interpretation of the captured images. Preliminary research on this issue has already been conducted. For example, Schmilovitch\u0026rsquo;s group utilized an otoscope integrated with a spectrometer in the same wavelength range as this work, achieving high sensitivity and specificity in diagnosing otitis media. However, it is important to note that the diagnostic accuracy in this case was based on the subjective judgment of the examining physician as the gold standard, with no paracentesis performed to verify the diagnosis, which limits the reliability of the findings [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMonroy\u0026rsquo;s group explored the use of optical coherence tomography (OCT) to diagnose both acute and chronic otitis media, focusing particularly on evaluating the presence of a biofilm. As in the previous case, the gold standard for diagnosis was the indirect otoscopic assessment, which further weakens the robustness of the results [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. More recently, Preciado and colleagues developed a prototype OCT otoscope that demonstrated promising results, with a sensitivity of 90.9% and specificity of 90.2%, and the ability to distinguish mucoid from serous effusions [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. However, as with other otoscopy modalities, a significant challenge remains: variability in user operation and interpretation.\u003c/p\u003e \u003cp\u003eUltrasound has been extensively studied for detecting middle ear effusion. Filling the ear canal with water to enhance wave transmission has achieved a 94% detection rate [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. But this approach is impractical in awake children, as water instillation may trigger vestibular symptoms by stimulating the horizontal semicircular canal. Another study investigated the detection of middle ear effusion using transmastoid ultrasound. The method was able to distinguish composition differences of middle ear fluid. However, it is highly operator-dependent, and variations in the scalp or mastoid anatomy may lead to inaccurate results. While promising, this technique requires further investigation [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The HSI technique could provide an interesting complement, as it is operator-independent and does not induce vertigo. Although it requires a very calm child as the patient. Combining both methods could potentially improve the detection accuracy.\u003c/p\u003e \u003cp\u003eTwo studies have also investigated the use of SWIR otoscopes, achieving high sensitivity rates of up to 90% by applying Random Forest methods to predict OME based on the intensity distribution of the image [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Despite these promising results, accurate differentiation between fluid-filled and air-filled middle ear cavities is highly dependent on the light intensity, e.g. due to the measuring distance, and the image output itself provides only limited diagnostic value. It is important to note that the reported SWIR otoscopes do not enable spectral differentiation, but record a single grey-scale image over a broad wavelength range. In contrast, HSI offers a high spectral resolution and thus the capability to calculate ratios between several wavelength ranges. This enables the compensation of external influences and allows distance-independent imaging of the water content.\u003c/p\u003e \u003cp\u003eThe primary limitations of this study include the use of NaCl as a solution, which does not match the viscosity of the mucous secretion found in middle ear effusions. This discrepancy may lead to a significantly faster drainage through the auditory tube into the nasopharynx. Additionally, the study was conducted exclusively on elderly body donors, limiting generalizability. Furthermore, the test group was relatively small; however, even within this limited cohort, significant results were obtained.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe current diagnostic approach for OME still has room for improvement. With false-positive rates reaching up to 30%, there is a clear need for more accurate diagnostic tools. HSI offers a highly sensitive and user-friendly quantification of intratympanic fluid. Its use could prevent unnecessary surgeries, sparing patients from unwarranted procedures while reducing financial strain on the healthcare system. Given our promising results with body donors, the next step is to validate these findings in clinical patient trials.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eOME\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOtitis Media with Effusion\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eHSI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHyperspectral Imaging\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eOCT\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOptical Coherence Tomography\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eSWIR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eShortwave Infrared\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTWI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTissue Water Index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eROI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRegion Of Interest\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eBERA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBrainstem-Evoked Response Audiometry\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eAll body donors had given their informed consent to donate their bodies for research and teaching purposes before their passing. The experimental protocols were approved by the Ethics Committee of the Medical Faculty of the University of Leipzig (129/21-ck). This study was conducted according to the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003eConsent for publication\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials\u003c/p\u003e\n\u003cp\u003eThe data is available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003eCompeting interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eOpen Access funding enabled and organized by Projekt DEAL.\u003c/p\u003e\n\u003cp\u003eAuthors\u0026rsquo; contributions\u003c/p\u003e\n\u003cp\u003eMG and HK wrote the initial draft, planned the experiments, and performed the data analysis. SL\u0026nbsp;enabled the measurements on the body donors. MG, HK, DGB, and MU conducted the experiments. AD, AM, and MP supervised the project. All authors reviewed the final manuscript.\u003c/p\u003e\n\u003cp\u003eAcknowledgements\u003c/p\u003e\n\u003cp\u003eThe authors would like to acknowledge technical support from KARL STORZ SE \u0026amp; Co. KG and Diaspective Vision GmbH.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eStrutz J, Mann W (eds) (2010) \u003cem\u003ePraxis der HNO-Heilkunde, Kopf- und Halschirurgie\u003c/em\u003e, 2., Vollst\u0026auml;ndig \u0026uuml;berarbeitete und erweiterte Auflage. 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J Telemed Telecare 24:453\u0026ndash;459. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/1357633X17708531\u003c/span\u003e\u003cspan address=\"10.1177/1357633X17708531\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJaisinghani VJ, Hunter LL, Li Y, Margolis RH (2000) Quantitative analysis of tympanic membrane disease using video-otoscopy, \u003cem\u003eLaryngoscope\u003c/em\u003e, vol. 110, no. 10 Pt 1, pp. 1726\u0026ndash;1730, Oct. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/00005537-200010000-00031\u003c/span\u003e\u003cspan address=\"10.1097/00005537-200010000-00031\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePreciado D et al (2020) Otitis Media Middle Ear Effusion Identification and Characterization Using an Optical Coherence Tomography Otoscope, \u003cem\u003eOtolaryngol Head Neck Surg\u003c/em\u003e, vol. 162, no. 3, pp. 367\u0026ndash;374, Mar. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/0194599819900762\u003c/span\u003e\u003cspan address=\"10.1177/0194599819900762\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Leipzig University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"tympanostomy, hyperspectral imaging, otoscopy, middle ear effusion, otitis media with effusion, tympanic membrane","lastPublishedDoi":"10.21203/rs.3.rs-9148677/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9148677/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eOtitis Media with Effusion (OME) is a prevalent childhood condition, affecting up to 90% of children with 10% progressing to a chronic state. It is commonly treated by tympanostomy tube placement. Diagnosis relies on clinical history, otoscopy, audiometry, and tympanometry, but these methods have a high false-positive rate of 15\u0026ndash;28%. This highlights the need for an objective, reliable, and non-invasive diagnostic tool to reduce unnecessary surgeries.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eTo evaluate the rate of false-positive OME diagnoses in our tertiary hospital, a retrospective database analysis was conducted. To assess the feasibility of advanced imaging, experimental studies were performed on human body donors. Sodium chloride solution was intratympanically injected under endoscopic guidance. Hyperspectral imaging (HSI) datasets were acquired using a customized endoscopic system to quantify tissue water content.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAn analysis of hospital records identified a false positive rate of 29% (n\u0026thinsp;=\u0026thinsp;4,564) for OME diagnosis, comparing the number of paracenteses to paracenteses plus tympanostomy tubes. In the ex vivo analysis of HSI, visual evaluation of the Tissue Water Index (TWI) demonstrated sensitivity, specificity, and accuracy of 89%, 78%, and 83%, respectively. The mean TWI of all evaluated tympanic membranes was 50.2 (\u0026plusmn;\u0026thinsp;7.1) before injection (control) and increased to 62.8 (\u0026plusmn;\u0026thinsp;14.8) after injection.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eHSI presents a highly sensitive and user-friendly alternative for diagnosing OME. Its implementation could reduce unnecessary surgeries, minimizing patient burden and healthcare costs.\u003c/p\u003e","manuscriptTitle":"Diagnosis of Tympanic Effusions Using Hyperspectral Imaging to Prevent Unnecessary Paracentesis Procedures","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-18 09:02:33","doi":"10.21203/rs.3.rs-9148677/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fd4ce91d-3ffa-43d2-90a4-12e5b191d7ec","owner":[],"postedDate":"March 18th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":64652171,"name":"Biomedical Engineering"},{"id":64652172,"name":"Otorhinolaryngology"}],"tags":[],"updatedAt":"2026-03-18T09:02:34+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-18 09:02:33","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9148677","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9148677","identity":"rs-9148677","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}