510(k) · Cleared
ClearedResound Hes, Digitally Progr., Ite Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resound Corp. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Feb 22, 1989 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 22, 1989
- Review
- 93 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK884871 Resound Hes, Digitally Progr., Ite Hearing AidResound Corp. · 1989
- Descendant · cites it directly · 6 of its ownK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- Descendant · 2 generations on · 4 of its ownK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK130790 LYRIC2Phonak, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K964603Articular Hearing AidsDecibel Instruments, Inc. · 1996 · cites it directly6descendants
- K021867Insound XT Series Hearing AidInsound Medical, Inc. · 2002 · 2 generations on4descendants
- K081136Lyric Hearing AidInsound Medical, Inc. · 2008 · 2 generations on2descendants
- K130790LYRIC2Phonak, LLC · 2013 · 3 generations on1descendant
- K232999Lyric4 Hearing AidSonova AG · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884871 | Resound Hes, Digitally Progr., Ite Hearing Aid | Resound Corp. | 1989 | — |
| +1 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| +2 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| +2 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| +3 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +4 | K232999 | Lyric4 Hearing Aid | Sonova AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K964603 (Decibel Instruments, Inc., 1996) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K884871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K884871: Resound Hes, Digitally Progr., Ite 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/K884871
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026