FDA panel approves Envoy impantable ear device

Envoy Medical Minnesota

ST. PAUL, Minn.–A scientific panel of ear, nose and throat experts has unanimously recommended the Food and Drug Administration approve a new implantable device designed to treat hearing loss.

The advisory panel voted 15-0 to green-light Envoy Medical Corporation’s Esteem-Hearing Implant, a device that senses movements along the ear drum and sends a calibrated dose of energy to the cochlea, a hollow, conical chamber of bone in the inner ear that transmits electric signals to the brain.

CEO Patrick Spearman said he expects the FDA to grant Envoy’s Premarket Approval (PMA) application by next February. Although FDA advisory panel recommendations are not binding, the agency almost always follows them.

The panel’s decision “means the world,” said Spearman, who was celebrating with his colleagues at a bar in Washington, D.C. “This is big.”

Envoy, formerly known as St. Croix Medical Inc., recently raised nearly $7 million from the sale of equity and debt, according to a filing with the Securities and Exchange Commission. Glen Taylor, the billionaire owner of the Minnesota Timberwolves, has also invested $20 million in Envoy, giving him a 15 percent stake in the company.

Thomas Lee

Thomas Lee was the Minnesota Bureau Chief for MedCityNews.

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Tags: Envoy Medical, Glen Taylor, Minnesota, Securities and Exchange Commission, St. Paul, U.S. Food and Drug Administration

Comments Post a comment

You say this is the first implantable device to treat hearing loss??
I have a Nucleus Freedom made by Cochlear America and they just came out
with the Nucleus 5 which I am in the process of starting the paper work to
have implanted on my right side. These both are Implants, so I don’t think
it can be said that Envoy is the first to come up with this idea!!!

Comment by Sandra Hunter — December 18, 2009 @ 9:20 pm

What an exciting product! Sandra, I see “new” but not “first” implantalbe device for the Envoy product…are you reading something different? It also says on Envoy’s website says it for sensorineural hearing loss and not a cochlear implant. It seems they’re for different applications, perhaps you should read their website?

Comment by Jon — December 19, 2009 @ 5:24 pm

WHOOP WHOOP Congratulations Envoy!!!!!!!!!!!!

Comment by Jeff Howell — December 20, 2009 @ 8:09 am

[...] At the end of the day, the ENT Panel voted to recommend approval for the device. The recommendation was unanimous. Here is the link to a breaking press announcement.http://www.medcitynews.com/index.php/2009/12/fda-panel-approves-envoy-impantable-ear-device/ [...]

Comment by Breakthrough Hearing Technology « Hearing Elmo — December 21, 2009 @ 12:48 pm

This is not a cochlear product and is different from the Nucleaus product – this is an alternative for hearing aids (a cochlear implant is for when hearing aids won’t work)

This is the first fully implantable system and it does not use a traditional microphone – it is very exciting technology!

Comment by Mary — December 21, 2009 @ 3:49 pm

What hasn’t been mentioned in articles like this one are the complications and mixed results many recipients have had in the clinical trials. It is far from a sure thing that someone who decides to splurge for one of these very expensive devices will be happy with the results. Hopefully, the technology will get there, but it is not there yet.

Comment by Dave — December 25, 2009 @ 10:26 pm

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Comment by More News Stories about Envoy Medical - Cole Family Blog — January 11, 2010 @ 11:30 am