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A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.

DUALINE 100 BTE

The provided document is a 510(k) clearance letter from the FDA for a hearing aid named "DUALINE DL100 BTE Hearing Aid" (K973948). It does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria in the way a modern AI/ML device submission would.

The letter explicitly states that the device is determined to be substantially equivalent to devices marketed prior to May 28, 1976. This means its performance is considered comparable to existing, legally marketed predicate devices, and a specific clinical study with detailed acceptance criteria and performance metrics (as requested in the prompt) is typically not required for such 510(k) clearances, especially for devices from 1997.

Therefore, I cannot extract the requested information from this document. The document describes the regulatory approval process based on substantial equivalence, not a detailed performance study against specific acceptance criteria.

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