PROJECT SUMMARY / ABSTRACT Up to 2.5 billion people worldwide will suffer from hearing loss or balance disorders by 2050, with a significant portion having underlying causes in the inner ear. This includes hearing loss due to age, noise and medications as well as various balance disorders, which in total afflicts approximately one in three people between the ages of 65 and 751. Atraumatic medical access into the inner ear is presently not possible, making diagnosis and treatment of cochlear-based hearing and balance disorders imprecise, relying on exclusion of other potential causes. Haystack Medical, Inc. is developing technology to provide clinicians with safe, direct access into the inner ear for diagnostic purposes. The product is called Endoscopy-Assisted intRacochlear aCcess via Ultrasharp-micRonEedles (EarCure). The founding team has been working together on this problem as an interdisciplinary research group out of Columbia University for the past decade. In this time, they have authored 12 journal articles and applied for 11 patents, 2 of which have been granted and 9 are pending. The team has invented and developed precision microneedle technology and carried out safety studies where they reach the inner ear through the delicate round window membrane. They are now turning this tool into a device that provides routine, safe access to the inner ear for valuable diagnostic data. Haystack Medical envisions this product to become a routine tool that will be used to diagnose the underlying cause of hearing loss and balance disorders, and help craft the best course or precise treatment for patients. For this purpose, in this STTR Phase I project, EarCure will be used to access the inner ear of human cadaveric temporal bones, only going through the tympanic membrane, making a hole as small as an ear tube for rapid healing. Furthermore, EarCure will be used to draw 1 µL amount of fluid from inside the inner ear, enough for diagnostic purposes, therefore demonstrating feasibility of the device. In the planned Phase II of the project, the team expects to enter clinical trials and begin translation of the tool to reach patients. The potential market for EarCure consists of all patients suffering from hearing and/or balance disorders with root causes in the inner ear. In the US alone, the market size for diagnosing hearing and balance disorders is greater than $5B, due to the number of people who seek treatment because of inner ear symptoms. Haystack intends the device to be sold through hospitals and reimbursed as other disposable medical devices. The company expects to pursue 510(k) clearance of the microneedle and actuation device, and will pursue a PMA if the FDA considers this device to be significantly different from predicates.

PROJECT NARRATIVE/PUBLIC HEALTH RELEVANCE More than 1.5 billion people worldwide suffer from hearing loss or balance disorders according to the World Health Organization, with a significant portion having underlying causes in the inner ear. Inner ear diagnostics are limited by the inability to atraumatically obtain samples of cochlear fluid due to the anatomic inaccessibility of the cochlea. The objective of this STTR is to create a product called EarCure that enables minimally invasive access to inner ear fluids using novel microneedle technologies combined with endoscopy. The EarCure solution is expected to provide new insight into better diagnosing and treating inner ear disorders and usher in a new era in inner ear medicine.