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FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
Date:3/17/2010

MINNEAPOLIS, March 17 /PRNewswire/ -- On March 17, 2010 the FDA gave approval to Envoy Medical Corporation to market a "First of its Kind" prosthetic hearing restoration device. The approval follows a December 18, 2009 unanimous 15 to 0 vote by an independent advisory panel in favor of approving the Esteem® for moderate to severe sensorineural hearing loss. The FDA chose an expedited review process, noting that they believe the Esteem® "represents a breakthrough technology."

In clinical trials, the Esteem® averaged a statistically significant increase in gain above hearing aids for Speech Reception Threshold (SRT) and Word Recognition Scores (WRS). Patrick Spearman, CEO of Envoy Medical, was quoted as saying: "This is huge. It means that sufferers of sensorineural hearing loss [approx. 90% of hearing loss sufferers] can now have a chance to hear much better than with conventional hearing aid technology."

Unlike hearing aids, the Esteem® does not use a microphone or a speaker. Instead, it uses the natural ear drum to detect sounds and sends a clear message to the brain, via the auditory nerve, by stimulating the cochlea with its prosthetic stimulator. Shelly Amann, President of Envoy Medical, noted: "Once implanted, Esteem® is invisible, not just to others, but the patient is also unaware of its presence in their body. Recipient
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SOURCE Envoy Medical Corporation
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