MSTATT LLC
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are: -Accuracy and usability of doctors using laser otoscopes Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Inclusion Criteria: * Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement * Between the ages of 6 months to 18 years at the time of consent * Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection Exclusion Criteria: * History of prior ear tube placement * Anatomical abnormalities of the t…
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
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