510(k) · Cleared
ClearedTranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic
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 6, 1998 after a 77-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Mar 6, 1998
- Review
- 77 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK974751 Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicGeneral Hearing Instruments, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK132965 Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014
- Descendant · cites it directly · 0 of its ownK093715 Evok 900 Series Hearing Aid/Tinnitus Masker Option DeviceMagnatone Hearing Aid Corp. Dba Persona Medical · 2010
- Descendant · cites it directly · 0 of its ownK083488 Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRTAudifon-USA, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK031624 Tinnitus RXTinnitus Control, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K982451Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999 · cites it directly2descendants
- K132965Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014 · 2 generations on0descendants
- K093715Evok 900 Series Hearing Aid/Tinnitus Masker Option DeviceMagnatone Hearing Aid Corp. Dba Persona Medical · 2010 · cites it directly0descendants
- K083488Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRTAudifon-USA, Inc. · 2009 · cites it directly0descendants
- K031624Tinnitus RXTinnitus Control, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974751 | Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic | General Hearing Instruments, Inc. | 1998 | — |
| +1 | K982451 | Ttcghi-T and TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999 | — |
| +2 | K132965 | Solace Sound Generators | Amplisound Hearing Products & Services | 2014 | — |
| +1 | K093715 | Evok 900 Series Hearing Aid/Tinnitus Masker Option Device | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010 | — |
| +1 | K083488 | Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRT | Audifon-USA, Inc. | 2009 | — |
| +2 | K031624 | Tinnitus RX | Tinnitus Control, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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?
- Of its descendants, K982451 (Tinnitus Treatment Centers, Inc., 1999) has gone furthest, with 2 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?
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a'lpw tolerance to loudness or when thg patient's response. to tinnitus is characterized by intolerence. ) Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities.. . When cosmetics are not an issue. No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a…
Read the full statement (172 words)
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a'lpw tolerance to loudness or when thg patient's response. to tinnitus is characterized by intolerence. ) Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities.. .
When cosmetics are not an issue.
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low tolerance to loudness or when the patient's response. to tinnitus is characterized by intolerence. . Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities.
When cosmetics are an issue.
No hearing loss or a mild to severe @igh frequency nearing loss where the patient exhibits allow tolerance to loudness or when the patient’s response. to tinnitus is characterized by intolerence. _ Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities.
When cosmetics are a major issue.
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/K974751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974751
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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