Envoy Medical and Mayo Clinic initiate a feasibility study of an implantable device for patients with significant hearing loss.
Envoy of White Bear Lake develops the Acclaim cochlear implant. Unlike a typical cochlear implant that requires users to wear an external sound processor behind the ear, Envoy’s would be the first such device to be fully implanted in the ear — if approved by the US Food and Drug Administration.
Cochlear implants are for people with severe hearing loss who cannot be helped by hearing aids.
Mayo’s venture is not a full clinical trial; it is defined by the FDA as an early feasibility study, requiring only a small number of patients to participate. This Acclaim study will have only three patients.
“People don’t like the external components,” says Dr. Colin Driscoll, a Mayo Clinic ENT specialist who specializes in head and neck surgery, will be the lead investigator on the study. He said patients with standard cochlear implants have trouble sleeping or showering.
“A fully implantable device really gives you the ability to hear 24/7,” Driscoll says. “There is no other fully implantable device [available] in the United States.”
Now that Envoy has been granted an “examination device waiver” from the FDA, Mayo can begin recruiting patients. Envoy will later need to complete a pivotal clinical trial to gain FDA approval.
The study will follow the patients for 12 months.
In 2019, Envoy received the “Breakthrough Device” designation from the FDA for the Acclaim. This gives the company more direct contact with regulators and can help speed up the approval process.
Founded in 1995, Envoy is a small company with approximately 25 employees. The Esteem implantable device has been available in the US since 2010.
CEO Brent Lucas originally joined Envoy in 2007 as an intern. After graduating from law school, he became a general counsel in 2009 and has held the highest position since 2015.
His father, Roger Lucas, was one of the founders of Envoy. The senior Lucas previously founded Research and Diagnostic Systems Inc. in 1976. That company was acquired in 1985 by Techne Corp. to create what is now Bio-Techne Corp. is, which is on track for $1 billion in revenue for the current fiscal year.
Envoy’s Esteem device has faced challenges.
“The Esteem has struggled to gain commercial traction,” said Lucas. “It’s not covered by Medicare and Medicaid, and it’s not robustly covered by commercial insurers.”
That’s largely because the Centers for Medicare & Medicaid Services classify Esteem as a hearing aid, which isn’t covered by those federal programs. However, cochlear implants are covered, Lucas said.
He said Acclaim’s commercialization is a few years away, but could be in the “mid-2020s.” An estimated 1.8 million Americans have severe hearing loss.
Glen Taylor, owner of the Star Tribune, is an Envoy investor.