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
United Hearing Systems, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Jul 1, 2005 as substantially equivalent to K923784 (Starkey Laboratories, Inc., 1992) and 4 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Jul 1, 2005
- Review
- 112 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K861971 (1986). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 3 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 2 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 1 generation backK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- This deviceK050653 Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005
- 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 |
|---|---|---|---|---|---|
| −4 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −3 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −2 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −1 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K050653 | Transear Bone Conduction Hearing Aid | United Hearing Systems, Inc. | 2005 | — |
| +1 | K100649 | Soundbite Hearing System by Sonitus | Sonitus Medical, Inc. | 2011 | — |
| +2 | K110831 | Soundbite Hearing System by Sonitus Medical | Sonitus Medical, Inc. | 2011 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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 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? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923784 | Starkey SM Series Bte Hearing AidsSummary page 2…onduction Conduction Hearing Aid Hearing Aid Hearing Aid Hearing Aid 510(k) No. Pending K923784 K884288 K953872 K021837… | 1992 |
| * | K884288 | Hearing Aid, Unitron Bte Model UM60-AGC0Summary page 2…Conduction Hearing Aid Hearing Aid Hearing Aid Hearing Aid 510(k) No. Pending K923784 K884288 K953872 K021837… | 1989 |
| * | K953872 | Second Ear Bone Conduction Hearing AidSummary page 2…Hearing Aid Hearing Aid Hearing Aid Hearing Aid 510(k) No. Pending K923784 K884288 K953872 K021837… | 1996 |
| * | K021837 | Branenmark Bone-Anchored-Hearing Aid (Baha)Summary page 2…ing Aid Hearing Aid Hearing Aid 510(k) No. Pending K923784 K884288 K953872 K021837 K042017 Desi… | 2002 |
| * | K042017 | Baha DivinoSummary page 2…K953872 K021837 K042017 Design Boneconduction Bone conduction Bone conduction Bone conduction Bone conduct… | 2004 |
| * | — | Various behind-the-ear air conduction hearing aids consisting of a digital sound… Named without a submission number |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K100649 (Sonitus Medical, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K923784.
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?
The TransEARTM Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050653 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050653: Transear Bone Conduction Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050653
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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