Search Results

• 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:

• Precipitously Sloping | X 1. Low Tolerance
  To Loudness |
  | X 2. Mild | X 2. Gradually Sloping | 2. ___ |
  | X 3. Moderate | ___ 3. Reverse Slope | 3. ___ |
  | X 4. Severe | X 4. Flat | |
  | ___ 5. Profound | ___ 5. Other | |

Not Found

The provided text is a 510(k) clearance letter from the FDA for a hearing aid device, the "Opus 2 - Full Concha Series - ITE." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it is a notification of substantial equivalence to a predicate device, allowing the manufacturer to market the product. It states the indications for use and general regulatory information.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• There is no table of acceptance criteria or reported device performance in this document.
• There is no information about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study in this document.

Ask a specific question about this device