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to amplify and transmit sound to the ear.
The indication for use of the air conduction hearing aids for 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: 1. Slight √, 2. Mild √, 3. Moderate √, 4. Severe √, 5. Profound √
Configuration: 1. High Frequency √, 2. Gradually Sloping √, 3. Reverse Slope √, 4. Flat √, 5. Other:
Other: Low tolerance to Loudness
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.

assembled from standard components that are widely used by other hearing aid manufacturers.
Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards.
Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k).
Controls: Volume control, Mode Switch, Audiological Controls (output and tone).
Power: Standard hearing aid battery (675)

This document set contains a 510(k) Summary for the Telex Select 1-40 with Adaptive Compression® FM at-the-ear Auditory Trainer. It describes the device, its intended use, features, and technical characteristics, and compares it to a predicate device.

After reviewing the provided documents, I can tell you that this submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It highlights the device's technical specifications complying with S3.2-1987 ANSI standards and its fit matching the frequency response per the same standard. However, it does not explicitly define acceptance criteria for performance, nor does it present the results of a study to demonstrate compliance with such criteria.

The information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is typically found in detailed device validation reports or clinical study summaries, which are not part of this 510(k) summary.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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