# K961593: Intrastar Pre-Wired Faceplate for in-the-Ear Hearing Aids

- Pathway: 510(k) (Traditional)
- Applicant: Segi Hearing Aid Co.
- Decided: Nov 7, 1996 after 197 days
- Product code: LRB (Face Plate Hearing Aid)
- 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
Longest line of descent: 1 generation back to K884871 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884871: Resound Hes, Digitally Progr., Ite Hearing Aid, Resound Corp. (1989) Summary page 1.
- K902846: Prizm Hearing System, Audioscience, Inc. (1990) Summary page 1.

## Indications for use
The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.

Source page: https://510kreport.com/device/K961593
Methodology: https://510kreport.com/methodology