# K970665: Williams Sound, Personal FM, Hearing Helper

- Pathway: 510(k) (Traditional)
- Applicant: Williams Sound, LLC
- Decided: May 2, 1997 after 70 days
- Product code: EPF (Hearing Aid, Group And Auditory Trainer)
- 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
To improve the signal to noise ratio for a listener ir a var ety of vrvironmen:s where background noise, poor acoustics, and distance from a desired sound <ot rze contribue to hezring 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 Atention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate 1o severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.

Source page: https://510kreport.com/device/K970665
Methodology: https://510kreport.com/methodology