Envoy Medical is the 2012 recipient of the Invisible Disabilities Association Research Honors Award. Envoy Medical Corporation was chosen based upon their cutting edge research and creation of the Esteem®, an implantable, invisible, prosthetic hearing restoration device.
Envoy Medical Corporation was founded in 1995 to design, manufacture, and bring to market the world’s first, and only, fully implantable hearing restoration device not to use a microphone or speaker. Envoy Medical began its operations in March of 1996 and spent its first several years developing the breakthrough technology that has become Esteem® – The Hearing ImplantTM.
In August of 2009, Envoy Medical completed its Esteem® premarket approval (“PMA”) application and submitted it to the Food and Drug Administration. On August 27, 2009, the FDA notified Envoy Medical that they had received the Esteem® PMA application and decided to grant the application expedited processing for the following reason:
“We believe that the Esteem Totally Implantable Hearing System represents a breakthrough technology, which provides an alternative to non-implantable and partially implantable hearing aid technology.”
On March 17, 2010, Envoy Medical received the formal premarket approval letter from the FDA granting approval for commercial distribution of the Esteem®.