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.
