FDA clears Envoy's Esteem hearing aid

March 18, 2010 by MedCity News

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.

Envoy Medical logo

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.

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