510(k) · Cleared
ClearedCochlear Baha BP100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Bone Anchored Systems AB · LXB Hearing Aid, Bone Conduction
Cleared on Jun 17, 2009 as substantially equivalent to K042017 (Entific Medical Systems, Inc., 2004) and 6 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1986. 33 later devices descend from it.
- Decided
- Jun 17, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K861971 (1986). 16 ancestors in all. 33 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 4 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 3 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 2 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 1 generation backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- This deviceK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · cites it directly · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · cites it directly · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 2 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- Descendant · 2 generations on · 10 of its ownK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- Descendant · 3 generations on · 6 of its ownK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · cites it directly11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · cites it directly11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 2 generations on10descendants
- K132775Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013 · 2 generations on10descendants
- K161123Baha 5 Power Sound ProcessorCochlear Americas · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −4 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −2 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −1 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| 0 (this device) | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +1 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +1 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +2 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| +2 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
| +3 | K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K042017 | Baha DivinoSummary page 2…hree currently marketed sound processors in the family of processors available for use with the Baha® auditory osseointegrated-implant; namely, the Baha DivinoTM (510(k) K042017), Baha IntensoTM (510(k) K081606), and Baha Cordelle lI(510(k) K080363). Bench testing shows that the gain/output of the Baha BP1… | 2004 |
| * | K081606 | Baha IntensoSummary page 2…cessors in the family of processors available for use with the Baha® auditory osseointegrated-implant; namely, the Baha DivinoTM (510(k) K042017), Baha IntensoTM (510(k) K081606), and Baha Cordelle lI(510(k) K080363). Bench testing shows that the gain/output of the Baha BP100 are comparable to those for th… | 2008 |
| * | K080363 | Baha Cordelle IISummary page 2…ailable for use with the Baha® auditory osseointegrated-implant; namely, the Baha DivinoTM (510(k) K042017), Baha IntensoTM (510(k) K081606), and Baha Cordelle lI(510(k) K080363). Bench testing shows that the gain/output of the Baha BP100 are comparable to those for the marketed Baha Divino sound processor… | 2008 |
| * | K973880 | Sonix Hearing Aid Fitting and Programming SystemSummary page 2…nded use and works in the same manner as that of many programmable hearing aids and devices. Predicate devices proposed for the fitting software system are 510(k) number K973880 for the Sonix hearing aid fitting and programming system, 510(k) number K93 1372 for the Resound® portable prescriptive programmi… | 1998 |
| * | K931372 | Resound Portable Prescriptive Programming SystemSummary page 2…and devices. Predicate devices proposed for the fitting software system are 510(k) number K973880 for the Sonix hearing aid fitting and programming system, 510(k) number K93 1372 for the Resound® portable prescriptive programming system, and 510(k) number K942749 for the HI-PRO/NOAH universal hearing instru… | 1993 |
| * | K942749 | HI-Pro/Noah Universal Hearing InstrumentSummary page 2…ber K973880 for the Sonix hearing aid fitting and programming system, 510(k) number K93 1372 for the Resound® portable prescriptive programming system, and 510(k) number K942749 for the HI-PRO/NOAH universal hearing instrument by Madsen Electronics. Also unique to this new Baha sound processor is the abil… | 1994 |
| * | K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsSummary page 2…e predicate for obtaining data to assist in more accurate fittings by obtaining measurements for pure tones produced by the hearing device can be found in 5 10(k) number K984547 for the LGOB test using the Resound® digital 5000 series hearing devices. Although that approach uses suprathreshold measures to… | 1999 |
What descends from it? (33)
See all 337 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132278 | Cochlear Baha 4 Sound Processor | 2013 | 11 |
| K103594 | Ponto Pro Power | 2011 | 11 |
| K100193 | Otomag Bone Conduction Hearing System | 2010 | 5 |
| K121228 | Ponto Bone Anchored Hearing System | 2012 | 4 |
| K100649 | Soundbite Hearing System by Sonitus | 2011 | 1 |
| K171088 | Cochlear Baha SoundArc | 2017 | 0 |
| K110831 | Soundbite Hearing System by Sonitus Medical | 2011 | 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 23 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K132278 (Cochlear Americas, 2013) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K042017.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), for the following patients and indications: * 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)…
Read the full statement (232 words)
The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), for the following patients and indications:
* 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.
* Bilateral fitting of the BP100 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 or "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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090720: Cochlear Baha BP100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090720
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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