The FDA has given Envoy Medical’s landmark Esteem middle-ear implant clearance for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments. White Bear Lake, Minn.-based Envoy introduced the Esteem — the first fully implantable device to treat hearing loss in the U.S. — in 2010. Surgeons and audiologists who work closely with hearing […]
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MASSDEVICE ON CALL — Envoy Medical Corp.’s sales of its landmark hearing aid spiked 150 percent as a video of a patient hearing her own voice through the implant for the first time went viral on the internet.
In the short clip 29-year-old Sarah Churman, deaf from birth, cries as a clinician turns on the device for the first time. The video drew nearly 7.8 million views since late last month.
Envoy Medical Corp. hopes to raise $6.0 million in an equity-based round, according to documents filed with the Securities & Exchange Commission.
The White Bear Lake, Minn.-based company is the maker of Esteem, an implantable hearing aid with no readily visible external components.
The FDA approved the Esteem in March 2010.
Envoy Medical Corp. should send Rush Limbaugh a fruit basket.
Thanks in large part to Limbaugh’s plug on his radio show, White Bear Lake, Minn.-based Envoy recently raised another $16.4 million, including $10 million from hearing aid powerhouse Starkey Laboratories Inc., for its Esteem implantable hearing device.
The Food & Drug Administration approved Envoy Medical Corp.’s Esteem technology, the first fully implantable device to treat hearing loss in the U.S.
The FDA’s approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components, Dr. Jeffrey Shuren, director of the watchdog agency’s Center for Devices and Radiological Health, said in a prepared statement.