# K974242: Argosy Programmable Onque

- Pathway: 510(k) (Traditional)
- Applicant: Argosy Electronics
- Decided: Jan 20, 1998 after 69 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies): Severity: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping; Gradually Sloping; Flat; Other: steeply sloping. Other: Low Tolerance to Loudness.

Source page: https://510kreport.com/device/K974242
Methodology: https://510kreport.com/methodology