510(k) · Cleared
ClearedInsound XT Series 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 Nov 19, 2002 as substantially equivalent to K964603 (Decibel Instruments, Inc., 1996) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 166 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850123 (1985). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 1 generation backK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- This deviceK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK130790 LYRIC2Phonak, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
- Descendant · cites it directly · 0 of its ownK151025 iHearTestIhear Medical, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −1 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| 0 (this device) | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| +1 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| +1 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +2 | K232999 | Lyric4 Hearing Aid | Sonova AG | 2024 | — |
| +1 | K151025 | iHearTest | Ihear Medical, Inc. | 2015 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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…Aid, legally marketed in 2000, after the exemption of hearing aids from 5 10(k) Notification, effective February 19, 1998. The Decibel Articulate 0(964603), determined to be substantially equivalent to a pre-enactment device on December 6, 1996. 0 The Philips XP Series (… | 1996 |
| * | K921725 | Philip XP Series, in-the Canal Hearing AidSummary page 1…The Decibel Articulate 0(964603), determined to be substantially equivalent to a pre-enactment device on December 6, 1996. 0 The Philips XP Series (K921725),determined to be substantially equivalent to a pre-enactment device on August 1 I, 1992, Device Description: The InSound… | 1992 |
| * | — | Songbird Disposable Hearing Aid Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K081136 (Insound Medical, Inc., 2008) has gone furthest, with 2 descendants 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.
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 Insound XT 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 ENT physician and it 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 as stated in the FDA summary.
https://510kreport.com/device/K021867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021867: Insound XT Series 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/K021867
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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