SBIR-STTR Award

This SBIR Phase I project will focus on a novel medical ultrasound device for the accurate diagnosis of middle ear infections. The device uses a small transducer that transmits ultrasound energy into the ear canal to determine whether a middle ear infection is present, and whether an antibiotic is appropriate. The focus will be to design and optimize an air-coupled MEMS (microelectromechanical systems) ultrasound transducer. The device will be a cost-effective method to improve diagnoses and reduce antibiotics in a market in which 17.6M doctor visits per year are coded directly to middle ear infections in the U.S. Ear infections are the #1 indication for which antibiotics are prescribed for children and the #1 cause for surgery in childhood, costing more than $10B annually in the U.S. Accessing this market will require consistent device performance with low variability and rare failure, as well as the ability to perform manufacturing with a high yield.This SBIR Phase I project will seek to enable the development of the first known commercial medical product utilizing air-coupled (capacitive micromachined ultrasound transducer) CMUT technology. CMUTs have been proposed for many applications, but very few have moved beyond the early research stage due to the high degree of technical difficulty and cost required to translate a research device into one that generates consistent transducer performance with low variability and rare failure rate. The work of this proposal facilitates the investigators? goal by establishing fast automated assessment of CMUT performance, both electrically and mechanically. The investigators will design and construct test systems to rapidly and automatically evaluate electromechanical and acoustical performance of CMUT designs. The electromechanical system automatically evaluates electrical impedance across frequency and bias voltage. The acoustical test system automatically evaluates pulse-echo directivity and sensitivity of a given CMUT, across bias voltage and pulsing parameters. The authors propose to use the two test systems to determine electromechanical tests which can be done in the foundry at the wafer level, which are predictive of acoustic performance. NSF funding is being sought to make this challenging but promising CMUT technology a commercial reality.

This SBIR Phase II project will enable the development of the first known commercial medical ultrasound device utilizing air-coupled Capacitive Micromachine Ultrasound Transducer (CMUT) technology to diagnose otitis media. Otitis media is the number one indication for which antibiotics are prescribed for children, and the number one cause for surgery in childhood, costing $15+B annually in the US and resulting in 30M annual doctor visits in the US alone. Clinical studies show a diagnostic error rate averaging 50%. Today's tools are unable to accurately determine the presence, and much less the type, of effusion in the middle ear. This leads to significant over- prescription of antibiotics, over-referrals to specialists, and unnecessary surgeries. OtoNexus Medical Technologies, Inc. is developing a simple and sensitive medical device to provide diagnostic data to quickly and accurately diagnose both presence and type of otitis media.The work of this project will establish fast and economical assessment of CMUT sensor manufacturing performance, by electrical and acoustic measurements. OtoNexus will design and construct test systems to rapidly evaluate electrical and acoustical performance of CMUT sensors as an assessment of production quality. The Electrical Vector Impedance (EVI) test fixture provides an electrical surrogate measure for acoustic output, which can be performed rapidly at the wafer-level with 100% sampling. The Acoustic Output Measure (AOM) test fixture evaluates the pressure emitted by CMUT, and other acoustic performance parameters, after speculum final assembly. This project will develop test fixtures, methods, and processes for assessing production reliability and process consistency. The OtoNexus ultrasound device will be marketed to pediatricians and other primary care physicians, and will decrease prognostic uncertainty and resultant over-prescription of antibiotics, and place the tools for more accurate diagnosis into the hands of the very first clinician the patient sees. This will reduce costs by decreasing both antibiotic usage and specialist referrals and will also decrease required physician time by enabling a nurse or other physician extender to perform the test for otitis media.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.