BelleTorus Corporation
The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis. Only healthcare professionals will make the diagnosis. The investigators will compare the diagnosis made by physicians or physician extenders (healthcare professionals) against the description provided by the support AI app tool to determine the clinical relevance of the system and examine its use within a clinical setting.
Timely access to primary care physicians for diagnosing and treating otitis media (infection or inflammation of the middle ear) in pediatric patients is often limited in rural, low-resource, and skin-of-color communities, particularly in remote or at-home settings. This lack of access increases the risk of undiagnosed and untreated pediatric otitis media, potentially leading to severe and permanent complications, including hearing loss, deafness, tinnitus, impaired language development, cognitive deficits, and delayed educational development. A growing body of literature supports the accuracy…
Inclusion Criteria: * Patient must be aged 1 to 17 years old. * Patient must present with a primary middle ear complaint. * Parent of the pediatric patient must have the ability and willingness to provide informed consent and comply with study procedures and visits. * Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using the provided off-the-shelf otoscope for the required image capture. Exclusion Criteria: • Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by…
Belle AI for ear image assessment
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