# K970687: Williams Sound, Personal FM, Hearing Helper

- Pathway: 510(k) (Traditional)
- Applicant: Williams Sound, LLC
- Decided: May 2, 1997 after 67 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 in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.

Source page: https://510kreport.com/device/K970687
Methodology: https://510kreport.com/methodology