510(k) · Cleared
Recalled · 2010Lyric Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insound Medical, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on May 8, 2008 as substantially equivalent to K964603 (Decibel Instruments, Inc., 1996) and 2 other predicates after a 17-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2008
- Review
- 17 days
- Class
- Class I
- Product code
- ESD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K850123 (1985). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 2 generations backK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- 1 generation backK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- This deviceK081136 Lyric Hearing AidInsound Medical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK130790 LYRIC2Phonak, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −2 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| −1 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| 0 (this device) | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | — |
| +1 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K964603 | Articular Hearing AidsSummary page 1…legally marketing in 2000, after the exemption of hearing aids from 510(k) Notification, effective February 19, 1998. * The Decibel Articulate G1-P24-MS (K964603), determined to be substantially equivalent to a pre-enactment device on December 6, 1996. This device was market… | 1996 |
| * | K921725 | Philip XP Series, in-the Canal Hearing AidSummary page 1…substantially equivalent to a pre-enactment device on December 6, 1996. This device was marketed under the name inTune ® * The Philips XP Series (K921725), determined to be substantially equivalent to a pre-enactment device on August 11, 1992. · Insound Medical Lyric,… | 1992 |
| * | K021867 | Insound XT Series Hearing AidSummary page 1…* The Philips XP Series (K921725), determined to be substantially equivalent to a pre-enactment device on August 11, 1992. · Insound Medical Lyric, (K021867) determined to be substantially equivalent to K964603, K921725 and a pre-enactment device on November 19, 2002. Device D… | 2002 |
| * | — | Songbird Disposable Hearing Aid Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130790 | LYRIC2 | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2010 | Not classified | Z-1681-2010 | Process design | Manufacturing error could result in electrolyte leakage from the product's battery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K130790 (Phonak, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K964603.
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. 2008, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081136: Lyric Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081136
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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