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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).
Severity: Slight, Mild, Moderate, Severe, Profound
Configuration: 1. High Frequency - Precipitously Sloping, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat
Other: Low tolerance To Loudness

The ITE, ITC, and CIC air conduction hearing aids are devices previously given marketing approval by the FDA. Beltone will be adding a new circuit option, GM-3036 manufactured by Gennum, to each of the models and will market this circuit option under the name CSP II Programmable.

The provided text describes a 510(k) premarket notification for Beltone Series CSP II Programmable Hearing Aids. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the information required to populate the table and answer the subsequent questions (acceptance criteria, specific study details, sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not present within the provided text.

The document indicates that the technical characteristics comply with S3.22-1987 ANSI Standards, which would define certain performance acceptance criteria for hearing aids in general, but no specific study or reported performance against these standards is detailed. The FDA's letter explicitly states that "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement..." and that "...this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations." This further confirms that this is a regulatory approval document based on equivalence rather than detailed performance study results.

In summary, this submission relies on demonstrating that the new device (with a new circuit option) is substantially equivalent to previously approved hearing aids, rather than providing a detailed clinical study with specific acceptance criteria and performance data as might be found for a novel AI-driven diagnostic device.

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To amplify and transmit sound to the ear

The Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.

I am sorry, but the provided text describes a hearing aid (Beltone Composer 2000 BTE HP) and its general features, technical characteristics, intended use, and assembly. It does not contain any information about a study, acceptance criteria, or performance metrics in the context of a clinical trial or evaluation.

Therefore, I cannot provide the requested information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. If an MRMC comparative effectiveness study was done or its effect size.
6. If a standalone algorithm performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The text focuses on establishing substantial equivalence to another hearing aid (Maico Gamma RD BTE HP programmable hearing aid, K933291) based on identical components and compliance with ANSI S3.22-1987 standards for technical specifications. This implies a different type of regulatory submission, likely a 510(k) in the US, where equivalence is demonstrated rather than new clinical trials with detailed performance metrics against specific acceptance criteria.

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