Last Friday we reported that the FDA’s Ear, Nose, and Throat Advisory Committee has met to discuss whether to recommend approval of Envoy Medical‘s (St. Paul, Minn) fully implantable hearing aid. Now word is that the group unanimously voted to suggest giving the go ahead to allow marketing of the Esteem device in the US.
More details in the press release: FDA Advisory Panel Votes 15 to 0 in Favor of Approving Envoy Medical’s Esteem® Fully Implantable Hearing Restoration System…
Flashback: Esteem Totally Implantable Hearing Device Under Consideration for Approval in US