OtoNexus Medical Technologies, Inc. — Department of Health and Human Services SBIR Phase I: Y

Description

Project Summary Abstract Device for Otitis Media Diagnosis OtoNexus is developing the worldandapos s first medical device to provide definitive objective diagnostic data for the rapid and accurate diagnose middle ear infections called Otitis Media in children and adults This FAST TRACK proposal addresses the clinical difficulty of determining the nature of fluid behind the tympanic membrane ear drum in acute infection of the middle ear Acute Otitis Media AOM Clinical studies show that error rates false negative false positive among young physicians average Accurate detection of AOM depends on detecting and characterizing middle ear fluid Experienced examiners realize they err in at least of cases even when pneumatic otoscopy is used Medical practitioners diagnose M cases of Otitis Media each year at a cost of more than $ billion in the US Current diagnostic methods are decades old highly subjective and extremely ineffective Consequently Otitis Media is both the indication for antibiotic prescriptions in children and the cause for surgery for children Each year children under receive tympanostomy tubes accounting for more than of all ambulatory surgery in this group Excessive antibiotic treatment from over diagnosis of OM can lead to antibiotic resistance significant side effects and increased drug costs Under diagnosis can allow the infection to progress potentially requiring surgery or risking permanent hearing loss We propose to use Doppler Ultrasound DUS to judge the oscillation of the tympanic membrane TM after perturbing the membrane position Membrane mobility is reduced with increasing fluid viscosity DUS permits a fast and systematic evaluation of this mobility The proposed device can be used by physician and assistant alike DUS data can readily affirm the presence of middle ear effusion and estimate its nature The 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 effusion Phase I and then integrate the device into a hand held form factor suitable for testing and commercialization Phase II Model TM motions will be observed by DUS with a novel transducer to assess contents of the phantom middle ear and guide the development of signal processing to distinguish membrane mobility The device is expected to increase prognostic accuracy largely eliminate diagnostic uncertainty and resultant over prescription of antibiotics reduce unnecessary specialist referrals reduce instances of hearing loss damage and place the tools for accurate diagnosis of OM into the hands of the very first clinician the child sees !Narrative Project Narrative andquot Device for Otitis Media Diagnosis The diagnosis of middle ear infection Otitis Media in infants and children is difficult and imprecise leading to increased health care costs and overuse of antibiotics resulting in resistant organisms The proposed device will use novel ultrasound technology to examine for the presence and character of fluid in the middle ear the hallmark of infection resulting in increased diagnostic accuracy and supporting rationale for treatment The examination will be painless quick and accurate this device will be the first new advance in middle ear examination in four decades andquot