# K960741: Comfortone PHS

- Pathway: 510(k) (Traditional)
- Applicant: Comfortone America'S Value Hearing Aid Line
- Decided: May 7, 1996 after 74 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- 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. The FDA summary names no predicate by number.

## Indications for use
To amplifiy and transmit sound to the ear.

Source page: https://510kreport.com/device/K960741
Methodology: https://510kreport.com/methodology