510(k) · Cleared
ClearedArticular Hearing Aids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Decibel Instruments, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Dec 6, 1996 as substantially equivalent to K933407 (Starkey Laboratories, Inc., 1993) and 2 other predicates after an 18-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.
- Decided
- Dec 6, 1996
- Review
- 18 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850123 (1985). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- This deviceK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK130790 LYRIC2Phonak, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
- Descendant · 2 generations on · 0 of its ownK151025 iHearTestIhear Medical, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021867Insound XT Series Hearing AidInsound Medical, Inc. · 2002 · cites it directly4descendants
- K081136Lyric Hearing AidInsound Medical, Inc. · 2008 · cites it directly2descendants
- K130790LYRIC2Phonak, LLC · 2013 · 2 generations on1descendant
- K232999Lyric4 Hearing AidSonova AG · 2024 · 3 generations on0descendants
- K151025iHearTestIhear Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| 0 (this device) | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| +1 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| +1 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| +2 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +3 | K232999 | Lyric4 Hearing Aid | Sonova AG | 2024 | — |
| +2 | K151025 | iHearTest | Ihear Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K933407 | Starkey Tympanette Hearing AidSummary page 1…y Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate devices to which equivalence is claimed are: L o The Starkey Laboratories Tympanette (K933407), determined to be substantially - equivalent to a pre-enactment device on October 7, 1993, e The General Hearing Instruments In… | 1993 |
| * | K850123 | IN-TH-Ear Hearing AidSummary page 1…ympanette (K933407), determined to be substantially - equivalent to a pre-enactment device on October 7, 1993, e The General Hearing Instruments In-the-Ear Hearing Aid (K850123), determined to be substantially equivalent to a pre-enactment device on March 21, 1985; and ¢ The Resound Corporation Resound I… | 1985 |
| * | K884871 | Resound Hes, Digitally Progr., Ite Hearing AidSummary page 1…123), determined to be substantially equivalent to a pre-enactment device on March 21, 1985; and ¢ The Resound Corporation Resound ITE Hearing Enhancement System (HES) (K884871), determined to be substantially equivalent to a pre-enactment device on February 21; 1989. Device Description: The Articulate G… | 1989 |
What descends from it? (6)
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K021867 (Insound Medical, Inc., 2002) has gone furthest, with 4 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 | — |
What is it indicated for?
The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964603: Articular Hearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964603
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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