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The Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management. The Zen program is intended to be used in quiet where hearing everyday sounds is not critical.

The Zen program is an optional listening program within the Widex Mind 440 digital hearing aid family. It is a tool that generates and delivers a relaxing sound background. It may also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers. A broadband noise and as many as 4 melodic tone patterns that are generated using fractal mathematics can be selected as Zen programs. The clinician can adjust the characteristics (intensity, pitch and tempo) of each program and the patient can retrieve up to 3 programs with the touch of a program button. The Zen can be used with or without amplification.

A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: ✓1. Slight ✓2. Mild ✓3. Moderate ✓4. Severe Configuration: ✓1. High Frequency - Precipitously Sloping ✓2. Gradually Sloping ✓3. Reverse Slope ✓4. Flat Other ✓1. Low tolerance To Loudness B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intellicibility in background noise, must be supported by clinical data.) 1. 2. 3.

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