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The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that delivers beamlike sound that is clear to the listener. The beamed audio content begins to demodulate in the air within six inches of the emitter and results in a cone-like transmission of sound waves that can be directed towards the listener. This device is intended for sale as an over-the-counter product and can be used with any sound source and at any distance from 3 feet to 50 feet or more from the emitters (speakers). Ultrasonic technology has been used for many years in industry and is also utilized in medical devices, such as ultrasonic nebulizers. The ultrasonic sound waves this product is based upon have also used in commercial and localized communications, and they are below the ultrasonic sound safety limits established by OSHA as required by OSHA Noise Standard, 29 CFR 1910.95. The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document focuses on demonstrating substantial equivalence rather than defining explicit acceptance criteria in a quantitative pass/fail manner. The reported performance metrics are used to support this claim of equivalence and clinical effectiveness.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 10 adult patients with mild to severe hearing loss.
   • Data Provenance: Clinical study conducted at the California Hearing and Balance Center in La Jolla, CA (USA). Prospective data from a controlled audiology laboratory.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts establishing ground truth for the test set. However, a "controlled audiology laboratory" suggests that audiologists or similarly qualified professionals would have conducted and interpreted the speech tests.

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

   • Not specified. The study was a "single-blinded, randomized cross over clinical study," but no details on expert adjudication of results are provided beyond standard audiology testing procedures.

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:

   • No. This device is not an AI-assisted diagnostic tool, but rather an auditory trainer. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable. The clinical study does compare the HSS system to conventional speakers, showing a significant improvement in speech understanding with the HSS.

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

   • Yes, for the non-clinical testing, "Equivalency testing to a predicate device was performed by an independent laboratory pursuant to ANSI S3.2-2009," which would be a standalone assessment of the device's audio output characteristics.
   • The clinical study assessed the device's performance directly with human users, but it's not an "algorithm only" test as the device itself is a physical auditory system.

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

   • The ground truth for the clinical study was established by standardized audiological speech tests: Modified Rhyme Test (MRT), Consonant-Nucleus-Consonant (CNC) in quiet, and AzBio in noise. These are objective measures of speech understanding, which serve as the "ground truth" for evaluating the hearing device's effectiveness.

7. The sample size for the training set:

   • This device is not an AI/ML model that requires a "training set." It is an auditory trainer employing ultrasonic technology. The design and performance are based on engineering principles and verified through bench testing and clinical studies, not machine learning training.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of 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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The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons.

The Model PE 600 Series consists of:

1. The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light.
2. The Model PE 600R is a body worn infrared receiver. It receives the infrared light signals from the PE 600E and converts these signals to high level audio signals required by the hearing impaired listener. The audio signals can be adjusted to meet the user.
3. The PE 601R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. This devise is capable of stereo reception so that different audio signals can be received simultaneously and fed to each ear separately.
4. The PE 602R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. The device is capable of receiving infrared light signals transmitted on two separate frequencies. A switch on the headset allows the user to select the program frequency desired. The selected program is heard in each ear.

The provided text is a 510(k) summary for the Phonic Ear Model PE600 Series Infrared Group Amplification System. This device is an auditory assistance system for hearing-impaired individuals in various public settings.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to previously approved devices of the same type, rather than setting out specific numerical acceptance criteria. The information provided is descriptive of the system's capabilities and its equivalence.

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

The provided 510(k) summary does not detail a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). The document primarily cites clinical studies on FM Auditory Training Systems to substantiate the effectiveness claims related to increased speech understanding and word discrimination. It does not describe a new clinical trial specifically for the PE600 Series.

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

This information is not provided in the document. The substantiation for effectiveness claims references "many clinical studies" by specific researchers (Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A., and Dr. Thomas Giolas) but does not outline how ground truth was established within those studies or if they were done for the PE600 series directly.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This section is not applicable to the Phonic Ear Model PE600 Series Infrared Group Amplification System. This device is a sound amplification system, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in the way typically seen in medical imaging or diagnostic studies.

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

This section is not applicable as the device is not an algorithm, but a hardware-based amplification system.

7. The Type of Ground Truth Used

For the claims related to "increased speech understanding and word discrimination," the document states: "Effectiveness claims outlined in paragraph 16 have been NOTE: substantiated by the results of many clinical studies made over the years since the introduction of FM Auditory Training Systems. Three such study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A. and Dr. Thomas Giolas form a part of this 510(k) submission."

This indicates that the ground truth for effectiveness was established through prior clinical studies (outcomes data) on similar FM Auditory Training Systems, rather than a new, specific ground truth established for the PE600 series in this submission. The nature of these "clinical studies" would likely involve objective measures of speech recognition or discrimination in controlled listening environments.

8. The Sample Size for the Training Set

This information is not provided as this device does not involve a "training set" in the context of machine learning or AI models.

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

This information is not provided as it is not applicable to the type of device being described.

Summary of Limitations in the Provided Document for Your Request:

The document is a 510(k) summary from 1997 for an infrared group amplification system. Its purpose is to demonstrate substantial equivalence to predicate devices, not to present a detailed clinical study with quantifiable acceptance criteria, specific test/training sets, or AI performance metrics. Therefore, much of the information you requested (especially around sample sizes, expert qualifications, adjudication, MRMC studies, and AI-specific ground truth) is not present in this type of regulatory submission. The "study that proves the device meets the acceptance criteria" is broadly defined as prior clinical research on similar FM Auditory Training Systems, used to support the general effectiveness claims.

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This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. Auditory trainers are used primarily in institutions (schools, churches, theaters, etc.) to allow teachers, ministers, etc. to communicate with individuals with hearing deficits.

This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.

This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. The device is powered by low voltage batteries which are contained within a battery compartment that is fitted with a locking cover to prevent inadvertent opening. The battery circuit is fused to prevent over heating should a short circuit occur. The devices' plastic housing is made of Cycolac plastic. The device includes controls for maximum power output, sound pressure level of built-in receiver microphones and FM signal, CHG/LOW BATT LED, NO FM LED, enlarging lens for FM frequency channel number, a 3 position switch for operating modes, a 7 position FM level switch for each ear, a 7 position SSPL switch for each ear, a 7 position GAIN switch for each ear, a 7 position TONE switch for each ear, and a 2 position microphone switch. It uses solid state surface mount components and integrated circuits. The receiver's FM receiving frequency is controlled by 2 rotary switches accessible under a latching cover.

The provided document is a 510(k) notification for a medical device (Group Auditory Trainer, Model PE571R). It describes the safety and effectiveness of the device, but it does not contain the specific acceptance criteria or a study designed to prove the device meets these criteria in the typical sense of a clinical trial with predefined metrics.

Instead, the document focuses on demonstrating substantial equivalence to previously approved devices, a requirement for 510(k) submissions. The "effectiveness" section lists various features and functionalities of the device and how they contribute to its intended use. For these effectiveness claims, the document refers to existing clinical studies that support the general concept of FM Auditory Training Systems, rather than a single study specifically designed for this particular device model and its acceptance criteria.

Therefore, many of the requested information points cannot be directly extracted from this document in the way they would be from a clinical trial report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics with thresholds (e.g., "sensitivity must be >X%"). The criteria for acceptance are implicitly that the device is safe and effective, and substantially equivalent to predicate devices.
• Reported Device Performance: The document describes various features and functionalities as contributing to the device's effectiveness. These are qualitative descriptions of performance rather than quantitative measurements against specific criteria. For example, "The maximum power output of the receiver can be set to the appropriate level required by the user and then locked at that level to prevent over amplification..." describes a safety/effectiveness feature without providing a specific quantitative performance value or an acceptance threshold for that value.

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

• Not applicable for this document. The safety and effectiveness claims are based on substantial equivalence to predicate devices and general understanding of FM Auditory Training Systems, supported by existing literature. There is no specific "test set" for this particular device's performance in a clinical study detailed here. The technical specifications were obtained by testing devices per ANSI Standard ANSI.S3.22-1987, which is a standard for hearing aid characteristics, not a clinical test set in the usual sense.

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. No specific test set with ground truth established by experts for this device is detailed in the submission. The acceptance of the device relies on its technical specifications meeting standards and its features aligning with established principles of FM auditory trainers, as judged by the FDA.

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

• Not applicable. No specific test set requiring adjudication is detailed.

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 an auditory trainer, not an AI-powered diagnostic tool for interpretation by human readers. It's designed to assist hearing, not assist interpretation.

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

• Not applicable. This is a hardware device with specific audio processing capabilities, not an algorithm in the sense of AI. Its "performance" is its ability to transmit and amplify sound according to its design, which is tested against engineering standards (like ANSI S3.22-1987).

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

• For the claims of improved word discrimination, reduced effects of distance/reverberation (paragraph 17), the document references "many clinical studies made over the years since the introduction of FM Auditory Training Systems." It specifically mentions "Three such study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A. and Dr. Thomas Giolas form a part of this 510K submission." These studies would likely use outcomes data (e.g., speech recognition scores in various conditions) as their ground truth for demonstrating the effectiveness of FM systems in general. However, the details of how ground truth was established in those specific studies are not provided in this document.
• For the technical specifications, the "ground truth" is adherence to the ANSI Standard ANSI.S3.22-1987, which defines objective measurement methods for hearing aid characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable.

In summary, this 510(k) notification primarily relies on demonstrating that the device's design, features, and technical specifications are substantially equivalent to legally marketed predicate devices and adhere to relevant engineering standards. The effectiveness claims for FM auditory trainers in general are supported by existing clinical literature, rather than a new, dedicated clinical study specifically for this model with defined acceptance criteria and a test set.

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To improve the signal to noise ratio for a listener ir a var ety of ur vironments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.

Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilition of Central Auditory Processing Disorders, amplification for mild to moderate conductive and senonineural hearing loss, and amplification moderate to severe conductive and sensorineural bearing loss when used in conjunction with a personal hearing aid.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for the Williams Sound, Hearing Personal FM System. It does not contain information about acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert adjudication as requested in your prompt. This document is a regulatory approval notice, not a study report.

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To improve the signal to noise ratio for a listener in a variety of environments where background noise, the interest poor acoustics, and distance from a desired sound source contribute to hearing difficulty.

Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the list the find of open condification for Atention Deficit Disorders, Leaming De the the for the the for the Central Autory Processing Disorders, amplification for midd to moderate sombetive and sensiblities, hearing loss, and amplification for mild to moderate conductive and senso hearing loss, and amplification for mild to moderate conductive and sensorineural conjunction with a personal heating and sensorineural hearing loss when used in conjunction with a personal hearing aid.

WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 100 / PFM 200

The provided document is a 510(k) substantial equivalence letter for a hearing assistance device (Williams Sound, Hearing Personal FM System Model PFM 100/200). It does not contain any information regarding acceptance criteria, study details, or performance data for the device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study of the device's performance against specific acceptance criteria.

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