510(k) · Cleared
ClearedTci Combi (Tinnitus Control Instrument Combination)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Hearing Instruments, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Apr 24, 2001 after a 158-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Apr 24, 2001
- Review
- 158 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 5 citing it directly.
- This deviceK003558 Tci Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001
- Descendant · cites it directly · 22 of its ownK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · 2 generations on · 13 of its ownK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- Descendant · 2 generations on · 6 of its ownK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK150171 Tinnitus Sound Generator ModuleGn Resound A/S · 2015
- Descendant · cites it directly · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008 · cites it directly22descendants
- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · 2 generations on13descendants
- K111293Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011 · 2 generations on6descendants
- K150171Tinnitus Sound Generator ModuleGn Resound A/S · 2015 · 3 generations on3descendants
- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003558 | Tci Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | 2001 | — |
| +1 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +2 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +2 | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
| +3 | K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015 | — |
| +1 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (29)
See all 295 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, K073636 (Gn Resound A/S, 2008) has gone furthest, with 22 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/K003558 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003558: Tci Combi (Tinnitus Control Instrument Combination).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003558
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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