New low cost technology for early detection of ear disorders

Most conductive hearing loss stems from pathologies affecting the tympanic membrane (TM), including perforations, retraction pockets, cholesteatoma, atelectasis, and tympanosclerosis. These conditions often go undetected until significant hearing loss has already developed. Early detection is currently limited to otoscopic examination or audiological testing, both of which have drawbacks. Otoscopic exams performed by primary care providers during routine physicals have low sensitivity for detecting asymptomatic ear pathology, and audiological screening is not routinely conducted in individuals without reported hearing loss. As a result, these conditions are typically diagnosed only after irreversible damage has occurred. Standard otoscopic imaging provides only a surface view of the TM with no depth perception due to its monocular nature. In cases where the TM is transparent, the underlying ossicles may be faintly visible and used as depth references. However, many pathological conditions cause TM opacity, obscuring the ossicular chain. Advanced imaging methods such as MRI and CT are rarely used due to their high cost, the need for additional patient visits, and their relatively poor resolution of middle ear structures. To address this gap, we have developed a novel imaging device that enables real-time, 3D visualization of the TM and middle ear, including portions of the ossicles and cochlear promontory. This device, based on optical coherence tomography (OCT), captures detailed functional and morphological images in under five minutes, making it well-suited for clinical use. However, the current system's cost— approximately $60,000—remains a significant barrier to widespread implementation in primary care settings such as pediatric and family medicine offices, where routine screening could take place. This proposal aims to reduce the system cost to under $5,000 by leveraging advanced 3D printing technologies to develop a planar waveguide structure that remaps the imaging field of view. This innovation will enable Full-Field OCT in the spectral domain using an imaging spectrometer as the detector. We will develop a first prototype and validate its performance against the existing system in both healthy volunteers and patients, paving the way for broader adoption of this technology in primary care settings.