FDA Approved: Implantable hearing device

On March 17, 2010, the U.S. Food and Drug Administration (FDA) approved the first 100% implantable hearing device called the Esteem® Totally Implantable Hearing System by Envoy Medical Corporation. The goal of the device is to replicate the function of the middle ear bones and improve quality of life.

The Esteem®, which is implanted under the skin behind the ear, consists of three components: a sound processor, a sensor and driver that are all hermetically sealed and biocompatible.

Here’s how it works: the ear naturally receives sound from the environment and the eardrum vibrates. The sensor, which is attached to the middle ear bones, picks up the vibrations and sends it to the sound processor. The sound processor amplifies and filters the signal and sends the signal to the driver, which is attached to the stapes. The driver converts the electrical signal back to vibrations to be delivered to the cochlea. The cochlea then sends the signal to the brain for processing. An audiologist programs the sound processor and the patient has a remote control to adjust the volume and change programs.

The device has been in a clinical trial period for five years. Shohet Ear Associates Medical Group, Inc. of Newport Beach, CA was one of three sites in the nation to participate in the Esteem® clinical trials. They reported, “At a quiet conversation level, average patient speech understanding improved by more than 45% over their hearing aids.”

According to FDA documents, the Esteem is recommended for patients who meet the following criteria.

• Adult subjects 18 years of age or older
• Mild to severe sensorineural hearing loss
• Speech discrimination test score greater than 40%
• Normally functioning Eustachian tube
• Normal middle ear anatomy
• Adequate space for the Esteem® implant

Another criteria that I believe should be included based on my educational training is that patients are candidates if do not benefit from wearing conventional hearing aids. I am looking forward to working with this newly accessible technology and seeing the positive impact it will have on patient’s lives. FDA reports that long-term studies will need to be performed to examine safety and effectiveness, as a condition of the approval.

via FDA