There is great news for people suffering from hearing loss: On December 18th, an Advisory Panel of independent ENT experts unanimously recommended that the FDA approve the Esteem®, the first Fully Implantable Hearing Restoration System.
The Esteem device had been in the clinical trial stage for over five years. Shohet Ear Associates was one of three sites in the nation that finished the last clinical trial concluded in August. I had the privilege of testifying before the FDA on December 18th on the efficacy of this groundbreaking device.
Among the three sites participating 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 Esteem® before it can be marketed to the public. In most cases, the FDA does follow the Advisory Panel’s recommendation. Stay tuned for word on final approval by the FDA.
To read more on this development, click here.