What are the clinical trial results for the Esteem?
In order to gain license from the Food and Drug Administration (FDA) to commercially market and sell the Esteem, Envoy Medical had to go through what is called the "premarket approval" process. The premarket approval requirements are stringent, resource intensive, and highly regulated. It is incredibly difficult to get a new medical device approved through the FDA's premarket approval process (especially a medical device that is a first-of-its-kind), but, at the end of the day, consumers can rest assured that once the product's PMA application has been approved the product has met the FDA's high standards of safety and effectiveness.
One of the biggest requirements of a premarket approval application, is a closely monitored clinical trial. Envoy Medical designed the Esteem's clinical trial in close collaboration with the FDA. The overall goal of the trial was to demonstrate both the safety and the effective benefit of the Esteem to those with sensorineural hearing loss. In total, 57 patients were implanted, and then closely monitored. The data reviewed by the FDA and its panel of experts in order to grant Esteem premarket approval were data collected through 10 months on all 57 implanted patients. In addition, the patients were followed for another 5 years to demonstrate long-term safety and effectiveness.