510(k) · Cleared
ClearedIN-TH-Ear Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Hearing Instruments, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Mar 21, 1985 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 21, 1985
- Review
- 66 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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) | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| +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 | 1 | 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964603 | Articular Hearing Aids | 1996 | 6 |
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/K850123 · printed Nov 4, 2026
Cite this page
510(k) Report. “K850123: IN-TH-Ear Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K850123
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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