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The Tinnitus Phase-Out is intended to provide the temporary relief of tinnitus symptoms.

The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Tinnitus Rx. The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 210(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program. The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional. Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which timitus is a symptom before proceeding with non-medical tinnitus management. The Tinnitus Rx is intendod for the temporary relief of timnitus symptoms.

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on any commercially available player and listened to through commercially available headphones or speakers.