510(k) · Cleared
ClearedLyric4 Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonova AG · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Apr 11, 2024 as substantially equivalent to K130790 (Phonak, LLC, 2013) after a 202-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Apr 11, 2024
- Review
- 202 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K850123 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 4 generations backK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- 3 generations backK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- 2 generations backK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- 1 generation backK130790 LYRIC2Phonak, LLC · 2013
- This deviceK232999 Lyric4 Hearing AidSonova AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −4 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| −3 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| −2 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| −1 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K130790 | LYRIC2Summary page 4…lass I REVIEW PANEL: Ear, Nose, and Throat 1 PREDICATE DEVICE Phonak Lyric4 hearing aid (K130790) DEVICE DESCRIPTION Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for mont… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
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. 2024, 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 initially 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…
Read the full statement (136 words)
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 initially 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. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232999: Lyric4 Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232999
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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