(67 days)
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.
§ 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.