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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: X 1. Slight X 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low Tolerance To Loudness 2. 3.

OPUS 2 - COMPLETELY - IN - CANAL SERIES ( CIC ) Device Name:

This is a 510(k) premarket notification for a hearing aid, not an AI/ML medical device. Therefore, the information requested (acceptance criteria, study details, expert qualifications, etc.) related to AI/ML device performance is not applicable to this document.

The document discusses the substantial equivalence determination for the "OPUS 2 - COMPLETELY - IN - CANAL SERIES - CIC" hearing aid to legally marketed predicate devices, and its indications for use. It primarily concerns regulatory approval based on existing device classifications and general controls.

There is no information within this document about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for AI assistance.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

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