Novel Pediatric Hearing Screening Device

Unmet Need
According to the WHO, unidentified hearing loss is the most common and significant disability impacting pediatric development. Unidentified hearing loss poses a burden of over $750 billion and affects over 32 million children globally. Approximately 90% of babies born with hearing loss are from developing countries; however, less than 3.5% of them have access to hearing screening. By contrast, 95% of newborns in developed nations receive hearing screening within the first month of birth. The low rate of hearing screening in developing nations is due to a lack of trained personnel and cost-effective screening methods. Most hearing tests are delivered by a trained healthcare provider (e.g. an audiologist), but developing countries typically only have 1 such physician per 6 million people. Also, the screening devices used to perform hearing tests are expensive, costing $2,500-$25,000, and require soundproof studios to operate, which is often not possible in the dynamic and noisy healthcare setting of the developing world. Failure to identify hearing loss in the first few months of birth can cause delays in language comprehension by up to 4 years and affect the academic, social, and psychological development of the newborns. Thus, there is a need for a cost-effective and automated pediatric hearing test that can increase access to newborn hearing screening in developing countries.

Technology Description
OtoScreen is an affordable, smartphone-based otoacoustic emissions (OAE) device that utilizes bone conduction to quickly and accurately detect otoacoustic emissions produced by the ear bone. The device consists of a headband with bone transducers that stimulates OAEs in subjects and connects to a smartphone with the OtoScreen app. Unlike current devices that stimulate OAEs through air conduction (where a tone is sent through the ear canal to stimulate OAE in the inner ear), bone conduction separates the input stimulus and the OAE signal coming from the ear. This simplifies data analysis and eliminates undesirable signal noise. In the app, data collected by the headband is analyzed for signs of hearing loss. The app then displays a “pass” or “referral” result. In the case of a “referral” result, the app forwards the data to a specialist for further analysis. OtoScreen completely automates the screening exam. It only requires a healthcare provider to place the headband on the patient and start the exam by pressing a button, making it easy to obtain hearing screening without trained personnel. Unlike existing devices that require soundproof studios to operate, Otoscreen accurately detects otoacoustic emissions produced by the ear even when in noisy environments. The device is cost-effective and consists of easily obtainable off-the-shelf components such as single-board computers, bone transducers, and microphones. Because Otoscreen relies on accessible smartphone-compatible technology instead of expensive equipment, it enables wider screening accessibility in the developing world.

Stage of Development
The inventors have developed a prototype and successfully performed proof-of-concept testing on individuals with normal hearing. Pilot testing in India is planned.

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