Broader Impacts More than 90% of children experience at least one ear infection before age 5, making ear infections among the most common childhood conditions. Family Physicians and Pediatricians see more than 20 million suspected ear infection cases per year in the US. Approximately 40% of these are misdiagnosed infections in healthy ears, leading to 6-9 million unnecessary antibiotic prescriptions annually. In fact, ear infection is the leading cause of unnecessary antibiotic use in children, resulting in hundreds of millions of dollars wasted and millions of children placed at undue risk for adverse side effects. On a societal level, unnecessary antibiotic use and resultant resistant microorganisms adds $20B in excess healthcare costs annually. The Centers for Disease Control and Prevention, American Academy of Pediatrics, and American Academy of Family Physicians have identified improved ear infection diagnostics as necessary to slow the spread of resistant microorganisms. Unfortunately, despite updated clinical guidelines dating back to 1994, no significant reduction in unnecessary prescription rates has been achieved. Even a modest improvement in ear infection diagnosis has the potential to positively affect millions of children, save hundreds of millions in direct costs, and slow the evolution of resistant bacteria. Cactus invented Optical Tympanometry (OT) technology to improve ear infection diagnosis in primary care, where most cases are seen. Cactus technology is 98% accurate in a clinical study of 30 pediatric participants, and works in clean and waxy ears. Intellectual Merit Children affected with ear infection are most often too young to adequately describe their symptoms. Signs of ear infections are numerous, but they are also very non-specific. Clinical diagnosis is most commonly done by assessing a set of qualitative factors using an otoscope to provide a magnified view of the ear drum. Most clinicians look for middle ear redness. However, redness alone is less than 65% accurate, matching accuracy statistics observed in primary care. The American Academy of Pediatrics and American Academy of Family Physicians recommend an objective quantitative assessment of the presence or absence of middle ear effusion (MEE). In fact, Key Action Statement 1C in the AAP?s most recent Acute Otitis Media (active ear infection requiring antibiotic treatment, AOM) guideline states: Clinicians should not diagnose AOM in children who do not have middle ear effusion (MEE) Currently, MEE is often unassessed due to technology limitations. Existing acoustic and pneumatic devices are slow, subjective and can be painful to children. As a result, clinicians commonly prescribe a course of antibiotics out of a preponderance of caution, or to placate parents. Cactus invented OT as a rapid, seamless means of assessing MEE during otoscopy. This SBIR Phase I proposal validates a miniaturized embodiment of OT (LED-OT) built into the familiar otoscope.
Specific Aims Aim 1 (Month 0-2): Assembly and Repeatability & Reproducibility Study of LED-OT Otoscopes. Cactus has developed a patent pending (US62/675,056 & US161040195) LED-OT otoscope based on its innovative multiLED microchip, which houses all 13 wavelengths required for OT in a 6x6mm form factor. Cactus will assemble 6 LED-OT otoscope units for rigorous measurement repeatability and reproducibility assessment followed by clinical validation in Aims 2-3.
Aim 2 (Month 2-12): Clinical Data Collection IRB approved (UCI HS#2016-3039) data collection will take place under the supervision of UC Irvine Professor Elliot Botvinick via a sub-award. Clinical data collection mirrors that used in 510(k) applications for previously cleared acoustic devices and enables receiver operating characteristic (ROC) analysis of LED-OT otoscopy.
Aim 3 (Month 2-12): Clinical Data Analysis Clinical data analysis will be concurrent with data collection, with two specific goals. First, train OT?s statistical component. Second, validate performance of LED-OT in pediatric participants using ROC analysis. A successful outcome of this proposal will be validated LED-OT technology and 6 otoscopes prepared for a pivotal study in Phase II to compare LED-OT and acoustic methods in an office setting. Together, Phase I and II will prepare LED-OT for analytical and clinical trials necessary for a 510(k) application, encourage adoption of our revolutionary technology, and facilitate private investment and relationships with strategic partners.
Cactus Medical, LLC is developing a rapid, low-cost, non-invasive ear infection indicator to improve ear infection diagnosis in pediatric care settings. Cactus? SmartScope will provide physicians with an accurate indication of ear infection at the press of a button while they are performing their normal inspection of the ear drum through an otoscope. SmartScope technology has shown 98% accuracy in a pediatric clinical study. This device has the potential to save $1.5 billion annually and reduce the rate at which anti-bacterial resistance evolves by limiting unnecessary antibiotic prescriptions and protect millions of children from unnecessary antibiotic treatment.