Envoy Medical successfully completed a feasibility study in 2002. After a few improvements to the product design, pivotal clinical trials were initiated in 2004 in both the European Union and the United States. Envoy Medical received its CE Mark approval to market the Esteem® in the European Union in May of 2006.
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.
On March 17, 2010, Envoy Medical received the formal premarket approval letter from the FDA granting approval for commercial distribution of the Esteem®.
What is new at Envoy?
The Esteem® Hearing Implant is the only FDA-approved fully implanted active middle ear hearing device that is indicated for the treatment of moderate to severe sensorineural hearing loss in adults. It’s invisible, completely waterproof, and has a battery that lasts years – not weeks or months.
Hear, Look, and Live Life on Your Terms.
The remarkable Esteem® Hearing Implant is designed to provide qualified candidates with a unique combination of real-world benefits. The Esteem is:
- An INVISIBLE Solution — You don’t just hear better. You look and feel better. There are no external components. And nothing is in your ear canal.
- A GO-ANYWHERE Solution — There’s nothing to put in or take out. Exercise, shower, and even swim underwater. All with newfound freedom.
- A LONG-TERM Solution — Imagine a full-time hearing solution that’s up to the task 24/7/365. Even its battery lasts years—not weeks or months.
- A CONVENIENT Solution — You don’t remove it or clean it. You don’t misplace it or lose it. And there’s no daily maintenance. You just enjoy it.