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for use in treatment and control of tinnitus.

non-occluding Ultra-helix type shell, two power levels assembled from standard components that are widely used by other hearing aid manufacturers. measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode". typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls. Volume control, one Audiological Control (tone). Standard hearing aid battery (312)

This document is a 510(k) summary for the Telex Tinnitus-Companion, Models TC TRL and TC TRS. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information is not available in the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for the device's performance in treating or controlling tinnitus. Instead, it focuses on technical characteristics and comparison to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical study or a test set of patients/data to evaluate the device's efficacy or performance in treating tinnitus. The "test set" appears to refer only to the technical measurement of the device characteristics.

• Sample size for test set: Not applicable/not mentioned for clinical performance. Technical measurements were likely performed on a sample of the devices themselves, but the size is not specified.
• Data provenance: Not applicable/not mentioned for clinical performance. Technical measurements were conducted by Telex Communications, Inc. in Minneapolis, MN, USA.
• Retrospective or prospective: Not applicable/not mentioned for clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and known intended use for tinnitus maskers, not on a clinical trial with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no mention of a test set involving human judgment or interpretation.

5. 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 tinnitus masker, an auditory device, and not an AI-powered diagnostic or assistive tool for human readers/interpreters. There is no mention of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable to a tinnitus masker, which is a physical device intended for use by an individual. It does not contain an algorithm in the sense of AI or automated diagnostic software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe a study involving a clinical ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device, K963838 (Starkey TM Air conduction Tinnitus Masker), based on comparable intended use, technology, principles of operation, and safety/effectiveness considerations.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This document describes a medical device, not an AI model.

Summary of available information:

The provided document is a 510(k) premarket notification for a tinnitus masker. Its primary goal is to establish "substantial equivalence" to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does NOT include a clinical study with acceptance criteria, patient populations, or expert ground truth as would be found for new, complex therapeutic or diagnostic devices. The performance reported is largely in terms of technical specifications and a general statement of "no significant difference" compared to the predicate device.

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to amplify and transmit sound to the ear.
The indication for use of the air conduction hearing aids for 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: 1. Slight √, 2. Mild √, 3. Moderate √, 4. Severe √, 5. Profound √
Configuration: 1. High Frequency √, 2. Gradually Sloping √, 3. Reverse Slope √, 4. Flat √, 5. Other:
Other: Low tolerance to Loudness
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.

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, Mode Switch, Audiological Controls (output and tone).
Power: Standard hearing aid battery (675)

This document set contains a 510(k) Summary for the Telex Select 1-40 with Adaptive Compression® FM at-the-ear Auditory Trainer. It describes the device, its intended use, features, and technical characteristics, and compares it to a predicate device.

After reviewing the provided documents, I can tell you that this submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It highlights the device's technical specifications complying with S3.2-1987 ANSI standards and its fit matching the frequency response per the same standard. However, it does not explicitly define acceptance criteria for performance, nor does it present the results of a study to demonstrate compliance with such criteria.

The information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is typically found in detailed device validation reports or clinical study summaries, which are not part of this 510(k) summary.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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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.

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to amplify and transmit sound to the ear.

assembled from standard components that are widely used by other hearing aid manufacturers.

This document is a 510(K) summary for a medical device, specifically a hearing aid. It describes the device's technical characteristics and intended use, comparing it to a predicate device. However, this document does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the provided text does not include:

1. Acceptance criteria or reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
3. Information on MRMC comparative effectiveness studies or human reader improvement.
4. Results of a standalone algorithm performance study.
5. Type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

The document discusses compliance with "S3.2-1987 ANSI standards" for technical specifications and frequency response, but it does not detail specific performance metrics, the studies conducted, or the statistical results that would demonstrate adherence to these standards. It primarily serves as a descriptive summary for regulatory submission.

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to amplify and transmit sound to the ear.

assembled from standard components that are widely used by other hearing aid manufacturers.

Here's an analysis of the provided text regarding acceptance criteria and supporting study information:

Based on the provided 510(k) summary, there is no information about acceptance criteria and a study proving a device meets acceptance criteria in the way typically expected for an AI/diagnostic device submission.

This document describes a traditional medical device (an FM at-the-ear auditory trainer) and focuses on describing its features, intended use, and comparison to predicate devices, particularly in relation to technical specifications and standards.

Therefore, I will extract and present the available relevant information, and explicitly state where information requested in your prompt is not present.

Device Name: Telex Select 2-40 with Adaptive Compression® (FM at-the-ear Auditory Trainer)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe performance testing against a "test set" in the context of an AI/diagnostic device. The compliance mentioned is against established technical standards for audio devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no "ground truth" establishment described, as this is a device complying with technical performance standards, not interpreting clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is described.

5. 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 is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hardware device, not an algorithm. Performance is assessed against technical standards rather than human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The "ground truth" for this device's performance is adherence to the S3.2-1987 ANSI standard for hearing aids. This is a technical standard, not clinical ground truth derived from expert consensus, pathology, or outcomes.

8. The sample size for the training set

• Not applicable. This device does not have a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable. No training set is described.

Summary of available "study" information:

The "study" or justification for this device primarily relies on its compliance with the S3.2-1987 ANSI standard for hearing aids. This standard defines technical specifications for frequency response and other operational characteristics. The manufacturer states that the device's technical specifications and frequency response comply with this standard, as detailed in a separate specification filed with the 510(k). This is a declaration of adherence to established engineering and performance benchmarks, rather than a clinical trial or AI performance study.

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