FDA Advisory Panel Votes 15 to 0 in Favor of Approving Envoy Medical’s Esteem(R) Fully Implantable Hearing Restoration System
ST. PAUL, Minn., Dec. 21 /PRNewswire/ — Envoy Medical, a Minnesota corporation, has developed the first Fully Implantable Hearing Restoration System known as the EsteemÃ‚®. On December 18th, an Advisory Panel of independent ENT experts unanimously recommended that the FDA approve the EsteemÃ‚®.
Patrick Spearman, Envoy Medical’s Chief Executive Officer, was quoted as saying “This is great news for all sensorineural hearing loss sufferers. Envoy has been able to accomplish with the EsteemÃ‚® what hearing aids set out to do but were unable to. Our EsteemÃ‚® allows recipients the opportunity to hear naturally and restore their lives back to normal.” 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.
The Advisory Panel’s vote is a recommendation only, and the FDA will still have to formally approve the EsteemÃ‚®( )before it can be marketed to the public. In most cases, the FDA does follow the Advisory Panel’s recommendation.
EsteemÃ‚® – The Hearing Implant(TM) – 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).
SOURCE Envoy Medical