# K130790: LYRIC2

- Pathway: 510(k) (Traditional)
- Applicant: Phonak, LLC
- Decided: Jun 27, 2013 after 97 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: 4 generations back to K850123 (1985). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021867: Insound XT Series Hearing Aid, Insound Medical, Inc. (2002) Summary page 1.
- K081136: Lyric Hearing Aid, Insound Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K232999: Lyric4 Hearing Aid (2024), 0 descendants of its own

## Indications for use
The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

Source page: https://510kreport.com/device/K130790
Methodology: https://510kreport.com/methodology