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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, 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 400 CIC

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) premarket notification letter from the FDA for a device named "Dualine 400 CIC".

This letter confirms that the FDA has reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists the general indications for use of the hearing aid (to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing), and then specifies categories for severity, configuration, and other factors for hearing loss.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any test set or training set.
• Information on expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.

The FDA 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria as might be seen for a Pre-Market Approval (PMA) pathway.

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