Panel urges FDA to approve hearing device developed in White Bear Lake

It took 14 years and $105 million in funding, but a Food and Drug Administration panel last Friday recommended approval of a unique hearing device developed by White Bear Lake-based Envoy Medical Corp.

The device, called the Esteem hearing restoration system, received a rare unanimous vote by the 15-member FDA panel. While not binding, it is unusual for the FDA to buck a decision made by one of its panels. If the FDA approves the device, it can be sold in the United States.

Based on pacemaker technology, the Esteem system is implanted under the skin behind the ear in an out-patient procedure and is invisible to others. If approved, the device will cost users about $30,000, including surgery and follow-up testing. The device is approved in Europe and has been implanted in 250 people worldwide.

Envoy's CEO Patrick Spearman says the Esteem device could be as big for those suffering from hearing loss as Lasik surgery was for sight-impaired patients. "Envoy has been able to accomplish with the Esteem [device] what hearing aids set out to do but were unable to," he said. The device "allows recipients the opportunity to hear naturally and restore their lives back to normal."

The company, formerly St. Croix Medical, counts some heavy-hitters in the local business community as investors, including Minnesota Timberwolves owner Glen Taylor, who owns 15 percent of the company, and Techne Corp. vice chairman Roger Lucas, who has a 19 percent stake.

The company's pivotal clinical trial, used to gain the panel's recommendation, involved 57 patients implanted with the device. At a quiet conversation level, patients' speech understanding improved by more than 45 percent, on average, over that with hearing aids, the company said.

More than 21 million adults in the United States suffer from sensorineural hearing loss, a condition most commonly treated with microphone-based hearing aids. However, some people with hearing aids complain of poor sound quality, whistling noise, a limited battery life and poor fit and discomfort.

Janet Moore • 612-673-7752