510(k) · Cleared
ClearedViennatone an, Viennatone as Fidelity F228, Fidelity F229
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starkey Laboratories, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on May 10, 1994 after a 161-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
- May 10, 1994
- Review
- 161 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK935701 Viennatone an, Viennatone as Fidelity F228, Fidelity F229Starkey Laboratories, Inc. · 1994
- Descendant · cites it directly · 3 of its ownK121793 AN Evo 1, CS Evo 1, Contact Mini, ApollonAudifon-USA, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK172460 ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018
- Descendant · 2 generations on · 0 of its ownK260452 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151…Zdeer Technology (Henan) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261256 Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K121793AN Evo 1, CS Evo 1, Contact Mini, ApollonAudifon-USA, Inc. · 2012 · cites it directly3descendants
- K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018 · 2 generations on1descendant
- K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd. · 2026 · 2 generations on0descendants
- K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935701 | Viennatone an, Viennatone as Fidelity F228, Fidelity F229 | Starkey Laboratories, Inc. | 1994 | — |
| +1 | K121793 | AN Evo 1, CS Evo 1, Contact Mini, Apollon | Audifon-USA, Inc. | 2012 | — |
| +2 | K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| +2 | K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152… | Zdeer Technology (Henan) Co., Ltd. | 2026 | — |
| +2 | K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 LXB? 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 LXB device
- #1 K254296 Ossiclear (Ossiclear System)score 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121793 | AN Evo 1, CS Evo 1, Contact Mini, Apollon | 2012 | 3 |
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, K121793 (Audifon-USA, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LXB
79in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXB
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXB
261in 2025
MAUDE reports naming product code LXB, 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 | 4 |
| 2008 | 2 | — | 0 | 110 |
| 2009 | 2 | — | 0 | 76 |
| 2010 | 2 | — | 0 | 91 |
| 2011 | 5 | 189 | 0 | 123 |
| 2012 | 1 | — | 5 | 346 |
| 2013 | 5 | 103 | 0 | 640 |
| 2014 | 0 | — | 0 | 545 |
| 2015 | 2 | — | 0 | 824 |
| 2016 | 4 | 110 | 0 | 692 |
| 2017 | 1 | — | 0 | 379 |
| 2018 | 1 | — | 1 | 336 |
| 2019 | 1 | — | 0 | 497 |
| 2020 | 0 | — | 0 | 547 |
| 2021 | 4 | 79 | 0 | 490 |
| 2022 | 0 | — | 0 | 387 |
| 2023 | 0 | — | 0 | 348 |
| 2024 | 0 | — | 0 | 232 |
| 2025 | 2 | — | 0 | 261 |
| 2026 | 4 | 164 | 0 | — |
https://510kreport.com/device/K935701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935701: Viennatone an, Viennatone as Fidelity F228, Fidelity F229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935701
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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