Esteem, recommended by Advisory Panel of independent ENT experts for FDA approval
Envoy Medical has said that it has developed the first fully-implantable hearing restoration system, Esteem. On December 18th, an Advisory Panel of independent ENT experts recommended the FDA approval of the Esteem.
In the clinical trial, patients averaged an 11 decibel improvement in Speech Reception Threshold (SRT) scores beyond their hearing aids. At a quiet conversation level, average patient speech understanding improved by more than 45% over their hearing aids, claims the company.
Envoy Medical said that the Advisory Panel’s vote is a recommendation only, and the FDA will still have to formally approve the Esteem before it can be marketed to the public.
Esteem, the hearing implant, is surgically implanted, invisible to others and once approved for the US market will cost approximately $30,000 (including the device, surgery and audiometric testing), said the company.
Patrick Spearman, chief executive officer of Envoy Medical, said: “This is great news for all sensorineural hearing loss sufferers. Envoy has been able to accomplish with the Esteem what hearing aids set out to do but were unable to. Our Esteem allows recipients the opportunity to hear naturally and restore their lives back to normal.”