510(k) · Cleared
ClearedHearing Aid, Unitron Bte Model UM60-AGC0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unitron Industries, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Jan 3, 1989 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 3, 1989
- Review
- 83 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK884288 Hearing Aid, Unitron Bte Model UM60-AGC0Unitron Industries, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK953872 Second Ear Bone Conduction Hearing AidWordcomp International Communication Group (Wicg) · 1996
- Descendant · cites it directly · 2 of its ownK050653 Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK100649 Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK110831 Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K953872Second Ear Bone Conduction Hearing AidWordcomp International Communication Group (Wicg) · 1996 · cites it directly3descendants
- K050653Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005 · cites it directly2descendants
- K100649Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011 · 2 generations on1descendant
- K110831Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884288 | Hearing Aid, Unitron Bte Model UM60-AGC0 | Unitron Industries, Inc. | 1989 | — |
| +1 | K953872 | Second Ear Bone Conduction Hearing Aid | Wordcomp International Communication Group (Wicg) | 1996 | — |
| +1 | K050653 | Transear Bone Conduction Hearing Aid | United Hearing Systems, Inc. | 2005 | — |
| +2 | K100649 | Soundbite Hearing System by Sonitus | Sonitus Medical, Inc. | 2011 | — |
| +3 | K110831 | Soundbite Hearing System by Sonitus Medical | Sonitus Medical, Inc. | 2011 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 2 | 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? (4)
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, K953872 (Wordcomp International Communication Group (Wicg), 1996) has gone furthest, with 3 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/K884288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884288: Hearing Aid, Unitron Bte Model UM60-AGC0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884288
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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