The Food & Drug Administration approves Envoy Medical Corp.'s Esteem hearing aid system, the first such device with no external components to get the green light in the U.S.
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.
Envoy plans to start implanting 100 patients a month beginning in October at a new surgical center the company is building in Houston, which it will open in three months. The company is recruiting surgeons to train at its headquarters in White Bear Township, Minn., and a facility in Greensboro, N.C.
For Envoy, convincing physicians to embrace the new technology will be a top challenge, which is why the FDA approval is so important, CEO Patrick Spearman said in a interview.
“Once you get FDA approval, it’s just fun to talk to doctors,” he said.
Esteem also comes with hefty price tag: $30,000 out-of-pocket. But Schulman says the ultimate benefit — restoration of hearing loss — makes Esteem “a good value.”
In normal hearing, sound causes the ear drum to vibrate, moving fluid inside the cochlea, an oval-shaped area in the inner ear. The motion prompts tiny hairs to touch nerve endings, which convert the movement into electric signals sent to the brain.
In conductive hearing loss, sound moving through the outer and middle ear is blocked. Sensorineural hearing loss is more severe — the hairs don't vibrate properly, disrupting the electric signals to the brain.
Hearing aids, which rely on microphones to amplify sound, are flawed because they don't effectively filter unwanted noise. Patients are also self-conscious about wearing the devices.
The Esteem is located entirely in the ear. The system consists of a sensor, sound processor and driver. The sensor picks up vibrations from the ear drum and converts them into electric signals. The sound processor, a specially designed computer chip, cleans up the signals and boosts their power. Finally, the driver converts the signals back into mechanical vibrations and transmits them into the cochlea.
NeuWave Medical raised more than $25 million in equity financing as it works to advance the market...
ConforMIS files for an initial public offering worth up to $173 million for its customized joint...
Here's a look at some of the top legal news stories for medical device companies this week: PAD:...
Mind-controlled prosthetics allow quadriplegic Erik Sorto to drink his 1st beer in a decade by...