09-28-2006

Otologics LLC, Boulder, Colo, is currently enrolling patients in a clinical research study for a new fully implantable hearing device.

For many people, a hearing aid restricts activities because it has to be removed before participation. It can prevent them from swimming, aerobic activities, or playing tennis, and can interfere with sleeping and showering because of perspiration or other moisture.

A new investigational, fully implantable hearing device from Otologics is now being evaluated. Unlike traditional hearing aids, this device is surgically implanted under the skin. Nothing is worn in the ear canal and no part of the device is visible externally. A capsule containing a microphone and other electronics is implanted beneath the skin behind the ear. Sound is picked up by the microphone, processed, and sent to a transducer in the middle ear. The transducer then causes the middle ear bones to move, much like the eardrum causes the middle ear bones to vibrate in response to sound waves. In order charge the implant battery, users simply place a charging device over the skin at the location of the implant. The charger unit contains a convenient belt clip. A remote control turns the implant on and off, and controls the volume.

To be eligible, participants in the study must be at least 18 years of age, be in good health and meet the following criteria:

    •      Have normal middle ear bones
    •     Have moderate to severe sensorineural hearing loss
    •     Currently using a hearing aid in the intended implant ear
    •     Speak English

Some people who meet the criteria listed above may not be eligible to participate in this clinical study. This includes any person who

    •     Is pregnant
    •     Has a history of constant middle ear disease or infections
    •     Has inner ear disorders, such as Meniere’s syndrome or balance disorders
    •    Has neural disorders (retrocochlear or beyond the cochlea)

For more information, contact (866) 390-5506.