# K081136: Lyric Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Insound Medical, Inc.
- Decided: May 8, 2008 after 17 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850123 (1985). 6 ancestors in all.
2 later devices descend 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)
- K964603: Articular Hearing Aids, Decibel Instruments, Inc. (1996) Summary page 1.
- K921725: Philip XP Series, in-the Canal Hearing Aid, Philips Hearing Instruments Co. (1992) Summary page 1.
- K021867: Insound XT Series Hearing Aid, Insound Medical, Inc. (2002) Summary page 1.
- (no number) Songbird Disposable Hearing Aid: named in the summary without a submission number

## Most influential descendants
- K130790: LYRIC2 (2013), 1 descendant of its own
- K232999: Lyric4 Hearing Aid (2024), 0 descendants of its own

## Recalls of this device
- Jan 19, 2010 · Not classified · Z-1681-2010: Manufacturing error could result in electrolyte leakage from the product's battery.

## 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 y an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain 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/K081136
Methodology: https://510kreport.com/methodology