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Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The Articulate Fitting System™ is used with the Decibel Instruments ProDigit 2000™ Personal Digital Audiometer for audiometric testing, real ear measurements, and fitting and programming the commercially available Decibel Instruments Articulate Hearing Devices. The System has four main components:

• The legally marketed Decibel Instruments ProDigit 2000™ Personal Digital Audiometer, a computer-based audiometry system;
• The Decibel Instruments IntraCanal Probe™ (ICP), a transducer placed in the ear canal for audiometric testing;
• The Decibel Instruments IntraCanal Probe™ Interface, which provides the communication link between the ICP and the ProDigit 2000™ Audiometer and allows real ear measurements; and
• The commercially available HI-PRO hearing aid programmer with the Articulate Fitting software utilizes automated fitting algorithms and visual tools to program the Articulate Hearing Devices following audiometric evaluation.

Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is a 510(k) summary for an audiometer system from 1997, and details on modern AI-driven device studies are not present.

The document describes an "Articulate Fitting System™" primarily for audiometric testing and fitting/programming hearing aids. The performance data provided is for the IntraCanal Probe (ICP) component, which is a transducer.

Acceptance Criteria and Device Performance

There is no explicit table of acceptance criteria or reported device performance in the format of specific metrics (sensitivity, specificity, AUC) in this document. The performance data focuses on the electroacoustic characteristics of the IntraCanal Probe (ICP).

Study Details

Given this is a 510(k) submission from 1997 for an audiometer system, the concept of a "test set" and "training set" for AI/ML algorithms, as well as multi-reader multi-case studies, are not applicable in the modern sense. The "performance data" section focuses on hardware component validation.

1. Sample size used for the test set and the data provenance: Not applicable in the context of an algorithmic test set. The testing was conducted on the physical device component (ICP). The provenance of the data refers to "Decibel Instruments. Inc." as the conductor of the tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the ICP's electroacoustic performance would be established by engineering and audiometric standards, measured with calibrated equipment, not by expert consensus on clinical cases.

3. Adjudication method for the test set: Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an audiometer system, not an AI diagnostic tool that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes the "Articulate Fitting System™" as having "automated fitting algorithms and visual tools" and "auto-fit calculations." However, it clarifies that this system is intended to be used with the ProDigit 2000™ Personal Digital Audiometer by "trained and qualified audiologists or other audiometric professionals." Therefore, while there are automated elements, it's explicitly designed to operate with a "human-in-the-loop," and no standalone algorithm performance study is described. The performance data section focuses on the physical transducer (ICP), not the fitting algorithms.

6. The type of ground truth used: For the ICP, the ground truth was based on engineering and audiometric standards for electroacoustic performance (frequency response, linearity, maximum undistorted output) measured against specified limits.

7. The sample size for the training set: Not applicable. There is no mention of a "training set" for machine learning.

8. How the ground truth for the training set was established: Not applicable.

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The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Articulate G1 Series Hearing Aids:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Performance data" was evaluated, but it does not specify the number of hearing aids tested or where the test data came from (e.g., patient trials, lab-simulated environments).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to whether the devices meet technical specifications, not a clinical diagnosis or assessment requiring expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The assessment is against established technical specifications (ANSI S3.22-1996), not subjective human interpretation.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hearing aid, not an AI-powered diagnostic tool. The study described is a performance/compliance test, not a comparative effectiveness study involving human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's technical performance was measured directly against specifications. This is an evaluation of the device as a standalone product, not an algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is defined by the applicable specifications developed by the manufacturer in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". This is a technical standard/specification.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device that requires a training set. The performance evaluation is against a fixed set of technical specifications for hardware.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device and study.

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