In full surgical attire, R. Sterling Hodgson, an Oregon neurotologist—a surgeon specializing in hearing and balance disorders—peers through a microscope as he drills into a cadaver’s skull. The bone lab where he’s working is located in an industrial building in White Bear Lake occupied by Envoy Medical, a small medical technology firm. Hodgson is practicing a procedure that will allow him to implant a new device developed by Envoy Medical. Branded Esteem, it promises to restore hearing to those with severe to moderate hearing loss, without external aids. Before Hodgson can perform the procedure on his own, he needs to prove his proficiency.
“It’s a challenging surgery,” says Hodgson, who has two patients waiting for him to complete training. “I’ve been surprised at the level of precision it requires.”
Hodgson is one of about 60 U.S. surgeons who have either finished or are currently in the process of taking the training, which typically is spread over several sessions and takes about eight full days to complete.
In February, Envoy Medical obtained Food and Drug Administration approval to market Esteem in the United States. Fifteen years and $120 million in development, Esteem is modeled upon implantable pacemakers, to which it bears a strong resemblance. Unlike hearing aids, which incorporate tiny microphones to amplify sound, the device turns a person’s eardrum into a kind of natural microphone, allowing the brain to process a wider variety of sounds than “artificial” mics can pick up.
Though left for dead by some early investors, Envoy Medical has retained a core group of believers. Some are among Minnesota’s most successful entrepreneurs: Mankato-based printing-business billionaire and Minnesota Timberwolves owner Glen Taylor; Ken Dahlberg, founder of Miracle Ear and inventor of the first in-the-ear hearing aids; and Roger Lucas, founder of Minneapolis-based Techne Corporation, which owns two Minnesota biotechnology companies.
“I think [this technology] will replace a substantial share of the hearing aid market, but it will be gradual,” says Dahlberg, who owns about 3 percent of Envoy Medical. “Once people buy this, they are off the hearing aid market forever.”
But first, Envoy Medical needs to build its own market. Surgeons need to sign up to learn the procedure. And hard-of-hearing people need to be convinced that the $30,000 they’ll need to pay for Esteem and the surgical procedure—neither the device nor the surgery, with a few possible exceptions, is covered by insurance—is worth the cost.
