FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
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 EsteemÃ‚® for moderate to severe sensorineural hearing loss. The FDA chose an expedited review process, noting that they believe the EsteemÃ‚® “represents a breakthrough technology.”
In clinical trials, the EsteemÃ‚® 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 EsteemÃ‚® 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, EsteemÃ‚® is invisible, not just to others, but the patient is also unaware of its presence in their body. Recipients can resume a normal life.”
The direct cost to the recipient for the device and implant surgery is approximately $30,000. The company says that financing options are available, making it affordable to hundreds of thousands of sufferers. The pacemaker-type battery may last up to nine years and never needs to be recharged.
Further information can be found on Envoy Medical’s web site www.envoymedical.com or by calling toll free 866-950-HEAR (4327).
SOURCE Envoy Medical Corporation