Envoy Medical, St Paul, Minn, took a significant step in being able to offer its Esteem fully implantable hearing system in the United States.
On December 18, an Advisory Panel of 15 independent ENT experts unanimously recommended that the FDA approve the Esteem. Envoy Medical CEO Patrick Spearman 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.”
The device, based on pacemaker technology, is implanted under the skin behind the ear. Two leads extend into the middle ear from the device. Sound waves travel into the ear canal and set the ear drum into motion, causing the bones of the middle ear to vibrate. The device senses these movements and delivers a customized dose of energy to the cochlea, which transmits the signals to the brain.
In a clinical trial, patients using Esteem reportedly averaged an 11 dB improvement in 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. For more information, visit www.envoymedical.com.
[Source: Envoy Medical]