# K970974: Williams Sound, Personal FM System, Hearing Helper

- Pathway: 510(k) (Traditional)
- Applicant: Williams Sound, LLC
- Decided: May 2, 1997 after 46 days
- Product code: LZI (Device, Assistive Listening)
- Device class: 2
- Regulation: 21 CFR 874.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). To improve the signal to noise ratio for a listener in a variety of environments 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 10 noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.

Source page: https://510kreport.com/device/K970974
Methodology: https://510kreport.com/methodology