The US Food and Drug Administration announced the approval of the regard – an implanted hearing system used to treat sensible to severe sensorineural hearing loss.
It is a kind of permanent hearing loss and it is mostly caused by genetic factors. Or it may cause due to the damage of inner ear resulting from noise, viral infections and aging. The result is disability in understanding the speech.
The esteem system consists of external testing and programming instruments. And also there are three implantable components namely a sound processor, sensor and driver.
The consent of Esteem provides patients with an option to lessen their hearing loss by using a device with no readily visible external components,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
This system is mainly designed to lessen the effects of hearing loss in patients ages 18 years and older. Other criterion for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient’s capability to understand speech using Esteem should be similar to that of predictable hearing aids.
In a multi-center experimental study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on speech clearness test.