Search Results

A. General Indications: The indication for use of the air conduction hearing aids in 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: ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency -Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat

Sound F/XP Programmble Mini BTE Hearing Aid

The provided text is a 510(k) premarket notification letter from the FDA regarding a hearing aid device (Unitron Industries, Inc. Sound F/XP Programmable Mini BTE Hearing Aid).

This document does not contain information related to acceptance criteria or a study proving device performance against acceptance criteria.

The letter is primarily a regulatory approval document stating that the device is "substantially equivalent" to legally marketed predicate devices for specific indications of use. It outlines general compliance requirements, potential future concerns regarding electromagnetic interference, and contact information for regulatory advice.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

To amplify and transmit sound via air conduction to the ear.

Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids. Features: Three fitter controls - Cross over frequency, low channel gain, and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier. Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987. Fit: Hearing aid adjustment dictated by individual audiogram. Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off. Power : Standard hearing aid battery - size 13.

This document describes a hearing aid and focuses on its technical specifications rather than a study proving its performance against acceptance criteria. Therefore, I cannot extract the information you requested about acceptance criteria and a detailed study proving device effectiveness.

The document primarily provides:

• Device Name: Unitron Industries, Sound F/XP *4 Behind-The-Ear Hearing Aid
• Intended Use: To amplify and transmit sound via air conduction to the ear.
• Key Features: Three fitter controls (crossover frequency, low channel gain, threshold knee point), two-channel compression circuitry, Class D circuitry, telecoil with pre-amplifier.
• Technical Characteristics: States compliance with ANSI Standard S 3.22-1987.

Without a detailed clinical study report, it's impossible to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

To amplify and transmit sound via air conduction to the ear .

Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.

This document is a summary of safety and effectiveness information for a hearing aid, not a study report. It describes the device's features and intended use but does not contain information about acceptance criteria or a study demonstrating device performance against those criteria. Therefore, I cannot provide the requested information.

Ask a specific question about this device