510(k) · Cleared
ClearedLYRIC2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phonak, LLC · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Jun 27, 2013 as substantially equivalent to K021867 (Insound Medical, Inc., 2002) and 1 other predicate after a 97-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Jun 27, 2013
- Review
- 97 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K850123 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 3 generations backK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- 2 generations backK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- 1 generation backK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- This deviceK130790 LYRIC2Phonak, LLC · 2013
- Descendant · cites it directly · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K232999Lyric4 Hearing AidSonova AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −3 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| −2 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| −1 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| 0 (this device) | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +1 | K232999 | Lyric4 Hearing Aid | Sonova AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ESD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ESD device
- #1 K232999 Lyric4 Hearing Aidscore 8.4 · 5 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021867 | Insound XT Series Hearing AidSummary page 1…2 Classification Name: Hearing Aid, air conduction Predicate Devices MANUFACTURER'S NAME DEVICE'S TRADE 510(K) NUMBER NAME | 1 Insound Medical, Inc. Insound XT Series K021867 2 Insound Medical, Inc. Lyric Hearing Aid K081136 intended Use / Indications for Use KI30¥D JUN 27 2003 The Lyric 2 hearing a… | 2002 |
| * | K081136 | Lyric Hearing AidSummary page 1…n Predicate Devices MANUFACTURER'S NAME DEVICE'S TRADE 510(K) NUMBER NAME | 1 Insound Medical, Inc. Insound XT Series K021867 2 Insound Medical, Inc. Lyric Hearing Aid K081136 intended Use / Indications for Use KI30¥D JUN 27 2003 The Lyric 2 hearing aid is a disposable, extended-wear air conduction h… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K232999 (Sonova AG, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021867.
How does its category compare?
All ESD devicesESD Hearing Aid, Air-Conduction, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ESD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ESD
Too few ESD 510(k)s in any year since 2007 to give a median.
Recalls per year · ESD
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESD
53in 2025
MAUDE reports naming product code ESD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 12 |
| 2019 | 0 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130790: LYRIC2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130790
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026