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Ear Center: FDA Approves the Esteem® Implant

Envoy Medical's Esteem® Fully Implantable Hearing Restoration System was Approved by the FDA on March 17, 2010

Envoy Medical, a Minnesota corporation, has developed the first Fully Implantable Hearing Restoration System known as the Esteem®. On March 17, 2010, the FDA formally approved the Esteem® for marketing to the public.

Patrick Spearman, Envoy Medical's Chief Executive Officer, was quoted as saying "This is great news for all sensorineural hearing loss sufferers. Envoy has been able to accomplish with the Esteem® what hearing aids set out to do but were unable to. Our Esteem® allows recipients the opportunity to hear naturally and restore their lives back to normal." In the clinical trial, patients averaged an 11 decibel improvement in Speech Reception Threshold (SRT) scores beyond their hearing aids. At a quiet conversation level, average patient speech understanding improved by more than 45% over their hearing aids.

Esteem® - The Hearing Implant™ - is surgically implanted, invisible to others, and has been approved for the US market. The expected cost will be approximately $30,000/implant (including the device, surgery and audiometric testing).


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