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The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists. The target population for this product is primarily the adult population 18 vears of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.

Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument. They are prescribed for those people with hearing loss who do not have significant relief with a hearing aid alone. Dispenser or user adjustments permit selection of broad band or high or low frequency emphasis noise and aid response. It is essentially a tinnitus masker with a hearing aid added. Programmable volume controls are provided: one for noise level and the other for hearing aid gain. The dispenser, audiologist or user can mix the amount of noise and amplification as required.

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).

Magna-PWR, Magna-B, Integra 70-74, Futura 67M-68M, MP97, Supra 51-52, Supra 56-59 and Suprema 45-48 Hearing Aids

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): Severity: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low Tolerance To Loudness.

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