Search Results

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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Flat
Other: Low tolerance to loudness

The Vista completely in the canal (CIC) is a small instrument designed to fit competely in the ear canal. The volume control is a standard screw-set control and uses a #10A or 5A battery. The CIC fit reduces residual ear canal volume and results in the need for less gain, decreased chance of feedback, improvement of high frequency gain, decreased occlusion effect, and lesser self-masking. The CIC's circuits are assembled into a variety of different configurations including Class D, K-amp, and RGA Class A. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. Dispenser controlled Volume Control. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.

The provided document is a 510(k) premarket notification for a hearing aid, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims.

As such, the document does not contain the acceptance criteria or a study demonstrating the device meets performance criteria in the way a typical clinical trial for a new medical device would. Instead, the criteria outlined are related to technical specifications and intended use, and the "study" is a demonstration of compliance with existing standards and substantial equivalence.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: It's crucial to note that for a hearing aid, typical performance metrics would include aspects like gain, output, frequency response accuracy, distortion, battery life, and possibly specific psychoacoustic measures (e.g., speech intelligibility for specific scenarios if specific claims were made). The document only states compliance with ANSI S3.22-1987, which would cover many of these. The exact numerical performance values against specific ANSI tolerances are not presented in this document.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) submission, which relies on substantial equivalence to a predicate device, rather than a de novo clinical study with a "test set" in the traditional sense of evaluating device performance on patients.

• Sample Size: Not applicable in the context of a prospective clinical "test set" with patient data. The "sample" here refers to the device itself and its technical specifications compared against established standards and a predicate device.
• Data Provenance: The data provenance is primarily the technical specifications of the Vista V-38 CIC Hearing Aid itself, which are affirmed to comply with ANSI S3.22-1987. No patient-specific or clinical trial data is presented in this excerpt. The submission is based on the device's design, components, and stated compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not directly applicable to this type of submission. The "ground truth" for a 510(k) is often established by the predicate device's existing market acceptance and regulatory clearance, as well as by industry standards (like ANSI S3.22-1987) that expert committees have developed and approved.
• Qualifications of Experts: The experts involved in establishing the ANSI standards would be acousticians, audiologists, engineers, and other specialists in hearing aid technology. The FDA reviewers (e.g., Lillian Yin, Ph.D., Director of the relevant division) are the regulatory experts who determine if the submission adequately demonstrates substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of patient data that requires expert adjudication. The process is a regulatory review by the FDA based on the submitted technical documentation and comparison to a predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Vista V-38 CIC is a medical device (hearing aid), not an AI-powered diagnostic or assistive technology in the modern sense that would require such a study for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone performance study was not done. This concept primarily applies to AI/ML algorithms. The Vista V-38 CIC is a hardware device with specific electronic circuits ("Class D, K-amp, and RGA Class A"); its performance is inherent to its design and manufacturing, not an algorithm that operates independently.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is primarily:
  • Predicate Device Performance: The demonstrated safety and effectiveness of the legally marketed predicate device(s) that the Vista V-38 CIC claims substantial equivalence to.
  • Industry Standards: Compliance with recognized consensus standards, specifically ANSI S3.22-1987 for hearing aid specifications.
  • General Medical Understanding: The accepted medical understanding of hearing loss and the function of hearing aids (e.g., "to amplify sound for individuals with impaired hearing").

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI/ML algorithm development. This is a traditional medical device (hearing aid). The "training" for such a device would be the engineering and design validation process using standard components and established manufacturing practices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no "training set" for an AI/ML algorithm, there's no ground truth established for it. The "ground truth" (or basis of performance and safety) for a traditional medical device like a hearing aid is established through adherence to engineering principles, relevant national/international standards, and manufacturing quality controls.

Ask a specific question about this device