510(k) · Cleared
ClearedBIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · LXB Hearing Aid, Bone Conduction
Cleared on Jul 13, 2010 after a 151-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 13, 2010
- Review
- 151 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK100360 BIA300 Series Implant and Abutment, BI300 Implant, BA300 AbutmentCochlear Americas · 2010
- Descendant · cites it directly · 1 of its ownK153391 Sophono Bone Conduction Systems (S) Configuration and (M)…Sophono, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK121317 Cochlear Baha Implant SystemCochlear Americas · 2012
- Descendant · 2 generations on · 0 of its ownK243041 contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025
- Descendant · cites it directly · 0 of its ownK182116 BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018
Most influential descendants
Showing 4 of 4 · See all- K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc. · 2016 · cites it directly1descendant
- K121317Cochlear Baha Implant SystemCochlear Americas · 2012 · cites it directly1descendant
- K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025 · 2 generations on0descendants
- K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100360 | BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment | Cochlear Americas | 2010 | — |
| +1 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016 | — |
| +1 | K121317 | Cochlear Baha Implant System | Cochlear Americas | 2012 | — |
| +2 | K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025 | — |
| +1 | K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 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? (4)
3 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, K153391 (Sophono, Inc., 2016) 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. 2010, 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?
The Cochlear Baha®f auditory osseointegrated implant system using model B1300 implant and model BA300 abutment is intended for the following patients and indications for use: * Patients aged 5 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 45 dB HL for use with the…
Read the full statement (250 words)
The Cochlear Baha®f auditory osseointegrated implant system using model B1300 implant and model BA300 abutment is intended for the following patients and indications for use:
* Patients aged 5 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 45 dB HL for use with the BPI 00 sound processor, 55 dB HL for use with the Intenso sound processor, and 65 dB HL for use with the Cordelle LI sound processor.
* Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15 dB 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; SSDTM). 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.
* Baha for SSD is also indicated for any patient who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CR05.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100360
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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