Up to 2.5 billion people worldwide will suffer from hearing loss or balance disorders by 2050, with a significantportion having underlying causes in the inner ear. This includes hearing loss due to age, noise and medicationsas well as various balance disorders, which in total afflicts approximately one in three people between the agesof 65 and 751. Atraumatic medical access into the inner ear is presently not possible, making diagnosis andtreatment of cochlear-based hearing and balance disorders imprecise, relying on exclusion of other potentialcauses. Haystack Medical, Inc. is developing technology to provide clinicians with safe, direct access into theinner ear for diagnostic purposes. The product is called Endoscopy-Assisted intRacochlear aCcess viaUltrasharp-micRonEedles (EarCure). The founding team has been working together on this problem as aninterdisciplinary research group out of Columbia University for the past decade. In this time, they haveauthored 12 journal articles and applied for 11 patents, 2 of which have been granted and 9 are pending. Theteam has invented and developed precision microneedle technology and carried out safety studies where theyreach the inner ear through the delicate round window membrane. They are now turning this tool into a devicethat 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 theunderlying cause of hearing loss and balance disorders, and help craft the best course or precise treatment forpatients. For this purpose, in this STTR Phase I project, EarCure will be used to access the inner ear of humancadaveric temporal bones, only going through the tympanic membrane, making a hole as small as an ear tubefor 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 ofthe tool to reach patients. The potential market for EarCure consists of all patients suffering from hearingand/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, dueto the number of people who seek treatment because of inner ear symptoms. Haystack intends the device tobe sold through hospitals and reimbursed as other disposable medical devices. The company expects topursue 510(k) clearance of the microneedle and actuation device, and will pursue a PMA if the FDA considersthis device to be significantly different from predicates.
Public Health Relevance Statement: 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.
Project Terms:
