510(k) · Cleared
ClearedOssiclear (Ossiclear System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sounduct · LXB Hearing Aid, Bone Conduction
Cleared on Jul 22, 2026 as substantially equivalent to K212136 (Cochlear Americas, 2021) after a 203-day review. Its family tree reaches back 11 generations to 1986.
- Decided
- Jul 22, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K861971 (1986). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 7 generations between
- 3 generations backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- 2 generations backK202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software…Cochlear Americas · 2021
- 1 generation backK212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear…Cochlear Americas · 2021
- This deviceK254296 Ossiclear (Ossiclear System)Sounduct · 2026
Show all 11 generations
- Root · 11 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 10 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 9 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 8 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 7 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 6 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 5 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 4 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 3 generations backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- 2 generations backK202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software…Cochlear Americas · 2021
- 1 generation backK212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear…Cochlear Americas · 2021
- This deviceK254296 Ossiclear (Ossiclear System)Sounduct · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −10 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −8 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −7 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −6 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −5 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −4 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| −3 | K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016 | — |
| −2 | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6… | Cochlear Americas | 2021 | — |
| −1 | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha… | Cochlear Americas | 2021 | — |
| 0 (this device) | K254296 | Ossiclear (Ossiclear System) | Sounduct | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 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 K253431 Bone conduction Hearing Aid (BM100, BM300…score 14.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppSummary page 5…Hearing Aid, Bone Conduction - 21 CFR 874.3302, Class II Classification Panel Ear Nose & Throat 510(k) Number: K212136 Product Code: LXB ADHEAR System This summary include… | 2021 |
| † | K172460 | ADHEAR System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 23 ancestors has a recall of any class.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
Ossiclear System is indicated for the following patients aged 12 years and older: • Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction hearing threshold (measured at 0.5 1 2 and 3 kHz) should be better than or equal to 55 dB HL. • Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally moderate to profound conductive or…
Read the full statement (188 words)
Ossiclear System is indicated for the following patients aged 12 years and older:
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction hearing threshold (measured at 0.5 1 2 and 3 kHz) should be better than or equal to 55 dB HL.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally moderate to profound conductive or mixed hearing loss. Symmetrical bone conduction thresholds are defined as less than a 10 dB HL average difference between ears (measured at 0.5 1 2 and 3 kHz), or less than a 15 dB HL difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single sided deafness SSD). Normal hearing is defined as a pure tone average air conduction hearing threshold (measured at 0.5 1 2 and 3 kHz) of better than or equal to 20 dB HL.
• Any patient who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254296: Ossiclear (Ossiclear System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254296
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026