Introduction: PhotoniCare, Inc. is a medical device company nearing commercializing the ClearView, a handheld, optical imaging device for improved diagnosis of middle ear health. The purpose of this proposal, developed in conjunction with the affiliated FDA review committee, is to perform pivotal clinical studies and use the collected data to establish objective data analysis algorithms for FDA 510(k) clearance submission using, for the first time, production-equivalent PhotoniCare ClearView imaging devices. Significance: Ear infections affect 95% of all children, yet they are one of the most poorly diagnosed and managed diseases in all of medicine. Correctly identifying the absence or presence/type of middle ear effusion (fluid) through the non-transparent eardrum is critical to accurate diagnosis, and the limited current diagnostic tools suffer poor diagnostic accuracy (50-70%) due to inherent subjectivity and dependence on user experience. Therefore, objective, quantitative metrics to enable improved diagnostic accuracy is sorely needed to finally provide children afflicted by this disease with the correct treatment the first time. Hypothesis: The ClearView imaging system with image analysis algorithms will facilitate detection of the presence or absence of middle ear effusion, as well as classification of the type of middle ear effusion, with greater than 90% sensitivity and specificity, regardless of user experience.
Specific Aims : (1) Conduct a pivotal 300-subject clinical study to demonstrate the utility of ClearView M-mode images for detecting the presence of fluid in the middle ear by correlating image data with physician visual assessment of fluid characteristics and tympanometry measurements. (2) Quantitatively analyze collected middle ear effusions and demonstrate correlations between ClearView M-mode image data, effusion composition, and biomechanical properties, and how these relate to effusion type: serous, purulent, or mucoid. (3) Develop a quantitative image analysis algorithm for effusion detection and fluid classification based on M- mode image data for implementation into the ClearView user interface for improved effusion detection. Commercial Opportunity: The ClearView device will provide physicians with new, objective information, enabling better decision-making for antibiotic prescription and surgical intervention. This has the potential to impact the standard of care for ~1B children worldwide that experience ear infections, representing a commercial opportunity of ~$10-20B worldwide, based on our projections.
PROJECT? ?NARRATIVE Ear infections (otitis media) are highly prevalent in the pediatric population and represent a significant clinical diagnostic challenge. Accurate detection and classification of effusion (fluid) in the middle ear is a critical element for this diagnosis, and for making informed medical treatment decisions. The long-term goal of this work is to reduce healthcare costs and improve patient outcomes by addressing the low diagnostic accuracy and user experience dependence of current subjective methods, with a novel, non-invasive imaging tool capable of quantitative depth-resolved measurements to not only visualize the underlying infection behind the eardrum,? ?but? ?also,? ?with? ?automated? ?computer? ?algorithms,? ?minimize? ?user? ?experience? ?dependence? ?and? ?variability.
