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The Levo System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

The Levo System is designed to assist the qualified health care professional in evaluating the patient's tinnitus and preparing a customized sound therapy to be delivered to the patient during treatment. The Levo System provides idiopathic tinnitus masking treatment based upon sound stimulation during sleeping or waking hours. The Levo System consists of two proprietary software applications that are pre-installed on commercially available, off-the shelf consumer electronics (i.e., Apple® iPad® or iPad Air™ and iPod®. Custom-fit ear buds are provided with the device. The Levo System uses amplitude modulated tinnitus pitch matched tones, narrow-band noise centered at the tinnitus frequency, and broad-band noise.