510(k) · Cleared
ClearedCochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
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 Sep 29, 2021 as substantially equivalent to K202048 (Cochlear Americas, 2021) after an 83-day review. Its family tree reaches back 10 generations to 1986. 1 later device descends from it.
- Decided
- Sep 29, 2021
- Review
- 83 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K861971 (1986). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 6 generations between
- 3 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 2 generations backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- 1 generation backK202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software…Cochlear Americas · 2021
- This deviceK212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear…Cochlear Americas · 2021
- Descendant · cites it directly · 0 of its ownK254296 Ossiclear (Ossiclear System)Sounduct · 2026
Show all 10 generations
- Root · 10 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 9 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 8 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 7 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 6 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 5 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 4 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 3 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 2 generations backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- 1 generation backK202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software…Cochlear Americas · 2021
- This deviceK212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear…Cochlear Americas · 2021
Most influential descendants
Showing 1 of 1 · See all- K254296Ossiclear (Ossiclear System)Sounduct · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −9 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −7 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −6 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −5 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −4 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −3 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| −2 | K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016 | — |
| −1 | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6… | Cochlear Americas | 2021 | — |
| 0 (this device) | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha… | Cochlear Americas | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…Summary page 5…21 CFR 874.3300, Class II Classification Panel: Ear, Nose, and Throat Product Code: LXB 510(k): K202048 E. Purpose of Submission This Traditional 510(k) seeks clearance for the implementation of Remote Assist via updates made to Bah… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254296 | Ossiclear (Ossiclear System) | 2026 | 0 |
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 35 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K254296 (Sounduct, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202048.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 System is intended for the following patients and indications for use: • Patient of any age for use with the Baha Softband (or headband) or Baha SoundArc. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system. • 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 3kHz)…
Read the full statement (232 words)
The Cochlear™ Baha System is intended for the following patients and indications for use:
• Patient of any age for use with the Baha Softband (or headband) or Baha SoundArc. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
• 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 3kHz) 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 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 deadness: 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.
• 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 CROS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212136: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212136
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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