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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.

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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.

Ask a specific question about this device