Several clinical studies have demonstrated that electrical stimulation of the cochlea is effective for the suppression of tinnitus. Tinnitus suppression has been observed as a beneficial side-effect in cochlear implant (CI) recipients. Other clinical studies have demonstrated improved tinnitus suppression from CI’s with modified stimulation patterns specifically designed for tinnitus relief. Further studies have shown that tinnitus is suppressed by electrical stimulation delivered from electrodes that avoid deep intracochlear electrode insertion. CI’s, the preferred treatment for the deaf, require deep intracochlear electrode insertion, which damages the existing functional hearing of the cochlea. Jay T. Rubinstein, M.D., Ph.D., a Silere founder, has conducted, patented, and published pioneering work on the treatment of tinnitus with electrical stimulation.
Regulatory Plan
The clinical effectiveness and safety of Silere technology will be demonstrated with an initial single site study that will enroll ten subjects. Following this study , Silere will sponsor a four center clinical trial in Europe, with the objective of obtaining regulatory approval and CE Mark. Marketing and sales will commence in the European Union following CE Mark approval. In the United States, Silere will conduct a multi-center pivotal trial, concurrent with the CE Mark application in Europe. The clinical work in the U.S. will require an Investigational Device Exemption (IDE), and will support a request for Pre Market Authorization (PMA).
Each of these clinical and regulatory events is scheduled as key activities of the business development. It is expected that the clinicians who participate in these trials will become the initial customers for Silere’s products. We anticipate that these clinicians will publish and report on their experiences with this technology at various conferences and in publications in respected, peer-reviewed journals. Additionally, Silere plans to sponsor meetings and presentations describing the products, technology and clinical benefits using selected participants from the original clinical trials as speakers.
As Silere develops, it intends to continue sponsoring clinical research and to solicit various clinical experts to participate in these projects and present their results. The use of advisory boards whose members are recognized for their expertise will provide additional sources of input and counseling to Silere’s potential new customers.