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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: X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness

This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the Audallion® III Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura. The ability to program digitally the fitting parameters of the hearing device is the same as in the Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume. The Audallion® III Hearing System has the ability to retain up to four programs in memory, iust as the predicate device.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.