Device for Otitis Media Diagnosis

OtoNexus is developing the world s first medical device to provide definitiveobjective diagnostic data for the rapid and accurate diagnose middle ear infectionscalled Otitis Mediain children and adultsThis FAST TRACK proposal addresses the clinical difficulty of determining the nature of fluid behind the tympanic membraneear drumin acute infection of the middle earAcute Otitis MediaAOMClinical studies show that error ratesfalse negativefalse positiveamong young physicians averageAccurate detection of AOM depends on detecting and characterizing middle ear fluidExperienced examiners realize they err in at leastof cases even when pneumatic otoscopy is usedMedical practitioners diagnoseM cases of Otitis Media each year at a cost of more than $billion in the USCurrent diagnostic methods are decades oldhighly subjectiveand extremely ineffectiveConsequentlyOtitis Media is both theindication for antibiotic prescriptions in children and thecause for surgery for childrenEach yearchildren underreceive tympanostomy tubesaccounting for more thanof all ambulatory surgery in this groupExcessive antibiotic treatment from over diagnosis of OM can lead to antibiotic resistancesignificant side effectsand increased drug costsUnder diagnosis can allow the infection to progresspotentially requiring surgery or risking permanent hearing lossWe propose to use Doppler UltrasoundDUSto judge the oscillation of the tympanic membraneTMafter perturbing the membrane positionMembrane mobility is reduced with increasing fluid viscosityDUS permits a fast and systematic evaluation of this mobilityThe proposed device can be used by physician and assistant alikeDUS data can readily affirm the presence of middle ear effusion and estimate its natureThe present project is the basic step to determine the most efficient parameters for assessing TM mobility and therefore the presence and character of middle ear effusionPhase Iand then integrate the device into a hand held form factor suitable for testing and commercializationPhase IIModel TM motions will be observed by DUS with a novel transducer to assess contents of the phantom middle earand guide the development of signal processing to distinguish membrane mobilityThe device is expected to increase prognostic accuracylargely eliminate diagnostic uncertainty and resultant over prescription of antibioticsreduce unnecessary specialist referralsreduce instances of hearing loss damageand place the tools for accurate diagnosis of OM into the hands of the very first clinician the child sees