RESTOREAR DEVICES LLC — Department of Health and Human Services SBIR Phase II: NIDCD

Description

Project Summary The goal of our project is to finalize, validate, and prepare for regulatory approvals a device and probe for delivering localized, controlled therapeutic hypothermia to the inner ear. The device safety and efficacy will be tested for residual hearing preservation in cochlear implant surgeries by comparing pre- and post-operative hearing outcomes and intra-operative electrophysiological measurements. Extensive preclinical research was enabled by a NIDCD R21 and industry support that allowed development of a protocol for hypothermia delivery using a device and probe suitable for a rodent model. We propose here to re-engineer the device and probe for clinical implantation in the operating room, and prepare it for regulatory approval. We will also carry out first-in- patient studies for the therapy by implementing localized, therapeutic hypothermia for protection of hair cells and neural substrate during cochlear implantation. This approach brings a non-pharmaceutical therapy for residual hearing preservation to the market. Furthermore, hypothermia localized to the inner ear avoids challenges with systemic cooling or with delivery of drugs to the inner ear. The device and probe do not require alteration of the surgical approach or the implant electrode. The specific aims are motivated by our preclinical studies that have shown that hypothermia can preserve residual hearing long-term post-cochlear implantation. Ensuring the survival of sensitive hair cells and neural structures in the cochlea will lead to improved residual hearing preservation, which in the long-term can improve speech perception outcomes.