# K964603: Articular Hearing Aids

- Pathway: 510(k) (Traditional)
- Applicant: Decibel Instruments, Inc.
- Decided: Dec 6, 1996 after 18 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
Longest line of descent: 1 generation back to K850123 (1985). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933407: Starkey Tympanette Hearing Aid, Starkey Laboratories, Inc. (1993) Summary page 1.
- K850123: IN-TH-Ear Hearing Aid, General Hearing Instruments, Inc. (1985) Summary page 1.
- K884871: Resound Hes, Digitally Progr., Ite Hearing Aid, Resound Corp. (1989) Summary page 1.

## Most influential descendants
- 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
- K151025: iHearTest (2015), 0 descendants of its own

## Indications for use
The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing.

Source page: https://510kreport.com/device/K964603
Methodology: https://510kreport.com/methodology