FDA approves Envoy Medical's prosthetic hearing restoration device

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. 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.