FDA Approves First Fully Implantable Hearing Device

March 2010

Editor: Here's one development I'll be watching with great interest. Aside from the cosmetic aspects, the Esteem hearing device appears to offer real functional benefits. Are people ready to spend $30,000 on this type of device?

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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 EsteemR for moderate to severe sensorineural hearing loss. The FDA chose an expedited review process, noting that they believe the EsteemR "represents a breakthrough technology."

In clinical trials, the EsteemR 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 EsteemR 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, EsteemR 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.