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.

Grant Number: 1R21DC023404-01
NIH Institute/Center: NIH
Principal Investigator: Brian Applegate