510(k) · Cleared
ClearedTransear Bone Conduction Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ear Technology Corp. · LXB Hearing Aid, Bone Conduction
Cleared on Sep 8, 2006 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Sep 8, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK062404 Transear Bone Conduction Hearing AidEar Technology Corp. · 2006
- Descendant · cites it directly · 1 of its ownK100649 Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK110831 Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062404 | Transear Bone Conduction Hearing Aid | Ear Technology Corp. | 2006 | — |
| +1 | K100649 | Soundbite Hearing System by Sonitus | Sonitus Medical, Inc. | 2011 | — |
| +2 | K110831 | Soundbite Hearing System by Sonitus Medical | Sonitus Medical, Inc. | 2011 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100649 | Soundbite Hearing System by Sonitus | 2011 | 1 |
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, K100649 (Sonitus Medical, Inc., 2011) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics: 1) Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear. 2) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz - 4000 Hz with speech recognition…
Read the full statement (217 words)
TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics:
1) Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear.
2) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz - 4000 Hz with speech recognition ability less than 50% when presented in quiet, at a 40 dB sensation level relative to the user's speech reception threshold.
3) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz - 4000 Hz with a small dynamic range, for loudness less than 20 dB for amplified speech, which makes the use of an air conduction hearing aid intolerable to the user.
The "better" cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 dB HTL or better at 3000 Hz.
For individuals with a "better" ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 db HTL or better at 3000 Hz.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062404: Transear Bone Conduction Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062404
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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