earKART OMNI A remote audiometry testing device Validation of a remote testing hearing diagnostic audiometer for hospital and community settings

The rise in number of cases of disability caused by diseases of the ear and mastoid process mandates timely diagnosis and intervention. Diagnosis is the first and the most important stage of the recovery process. To estimate the hearing abilities of an individual pure tone audiometry is one of the most widely used audiological tests However, timely and accessible testing remains a challenge in low-resource and outreach settings. The conventional audiometers require appropriate sound treated audiological set up and patient’s presence for the testing procedure. It often results in delays and lack of accessibility. The earKART OMNI is a remote audiometry testing device that enables the audiologist to perform audiometry test for the patients who reside in remote areas or are unable to be physically present due to personal limitations. It facilitates the testing to take place with clinician and patient at two different locations. This results in minimized requirement of patient to travel to clinics or hospitals for such medical evaluations. Our study aims to validate the analytical performance of earKART OMNI against the gold standard diagnostic audiometer at a tertiary care hospital. We will evaluate 60 patient samples at AIIMS, New Delhi for analytical accuracy and linearity. The device will be compared with the standard audiometer and tympanometer and audiological test battery such as pure tone audiometry, tympanometry and speech audiometry will be performed. We expect this study to generate validation data for potential clinical deployment of earKART OMNI by assessing the device in terms of linearity and accuracy compared to commercially available device. this will improve accessibility to audiological testing for difficult to test population or subjects with limited mobility.The data collected will be instrumental in refining the device, developing implementation strategies and informing policy decisions for broader adoption.