(70 days)
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.
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.