What are the clinical trial results for the Esteem?

Posted by Envoy Medical Staff Member on November 9, 2018

Closeup of examining ear with an otoscope

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.

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Topics: clinical results, Esteem, hearing loss

Hearing loss is a lifelong journey that can be an emotional roller-coaster. It can be daunting, frustrating, and isolating. It is important to know, however, that you are not alone. You are one of tens of millions of people live with some type and level of hearing loss. There is a broad community of people who understand what you are going through. 
 
That being said, your journey is unique, and how you approach your hearing loss is up to you. Hopefully, with the support and guidance of family, friends, and, of course, hearing healthcare professionals.  
 
The Sounding Board blog is designed to provide some insight on everything from general hearing loss topics to the specific experiences of individuals willing to share some stories from their personal journey.
 
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