# K850123: IN-TH-Ear Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: General Hearing Instruments, Inc.
- Decided: Mar 21, 1985 after 66 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964603: Articular Hearing Aids (1996), 6 descendants of its own
- K021867: Insound XT Series Hearing Aid (2002), 4 descendants of its own
- K081136: Lyric Hearing Aid (2008), 2 descendants of its own
- K130790: LYRIC2 (2013), 1 descendant of its own
- K232999: Lyric4 Hearing Aid (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K850123
Methodology: https://510kreport.com/methodology