Search Results

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.

Ask a specific question about this device