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to amplify and transmit sound to the ear.

Intended use: to amplify and transmit sound to the ear. Features: Threshold Compression. 2-band compression. AC+ Assemblv: 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, Low Band Gain (optional), High Band Gain (optional), Crossover Frequency (optional), Threshold Control, Loudness Boost (optional), Set-screw Volume Control (optional), Low cut Switch (optional) Standard hearing aid battery (13, 312, 10A or 5A) Power:

This document is a 510(k) summary for a hearing aid, which is a medical device. It does not contain information about the acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report or a performance study.

The provided text focuses on:

• Device Identification: Trade name, common name, classification, and equivalence to a predicate device.
• Description: Intended use, features (Threshold Compression, 2-band compression), assembly from standard components, and technical characteristics (compliance with S3.2-1987 ANSI standards).
• Controls: Lists various optional controls like volume control, gain, frequency, and switches.
• Power: Standard hearing aid battery types.
• Comparison to predicate device: Highlights the difference being a new amplifier with dynamic range compression.
• Contact Information: For the submitter.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

To answer your request, I would typically need a document that describes a clinical study, a performance evaluation, or a validation study for a medical device, which would include sections on:

1. Clinical/Performance Parameters: What metrics were measured (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, audiometric thresholds).
2. Acceptance Criteria: The pre-defined thresholds for these parameters that the device must meet to be considered effective and safe.
3. Study Design: Details on population, sample size, ground truth establishment, expert qualifications, and adjudication methods.
4. Results: The actual performance observed in the study.

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to amplify and transmit sound to the ear.

assembled from standard components that are widely used by other hearing aid manufacturers.

This document is a 510(K) summary for a medical device, specifically a hearing aid. It describes the device's technical characteristics and intended use, comparing it to a predicate device. However, this document does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the provided text does not include:

1. Acceptance criteria or reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
3. Information on MRMC comparative effectiveness studies or human reader improvement.
4. Results of a standalone algorithm performance study.
5. Type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

The document discusses compliance with "S3.2-1987 ANSI standards" for technical specifications and frequency response, but it does not detail specific performance metrics, the studies conducted, or the statistical results that would demonstrate adherence to these standards. It primarily serves as a descriptive summary for regulatory submission.

Ask a specific question about this device