510(k) · Cleared
ClearedBranenmark Bone-Anchored-Hearing Aid (Baha)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entific Medical Systems, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Aug 30, 2002 as substantially equivalent to K955713 (Nobelpharma USA, Inc., 1996) after an 87-day review. Its family tree reaches back 2 generations to 1986. 40 later devices descend from it.
- Decided
- Aug 30, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861971 (1986). 4 ancestors in all. 40 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 1 generation backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- This deviceK021837 Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc. · 2002
- Descendant · cites it directly · 39 of its ownK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK081606 Baha IntensoCochlear Americas · 2008
- Descendant · 2 generations on · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 2 generations on · 19 of its ownK082108 Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008
- Descendant · 2 generations on · 18 of its ownK090996 Ponto ProOticon Medical AB · 2009
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K042017Baha DivinoEntific Medical Systems, Inc. · 2004 · cites it directly39descendants
- K081606Baha IntensoCochlear Americas · 2008 · 2 generations on35descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · 2 generations on33descendants
- K082108Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008 · 2 generations on19descendants
- K090996Ponto ProOticon Medical AB · 2009 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −1 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| 0 (this device) | K021837 | Branenmark Bone-Anchored-Hearing Aid (Baha) | Entific Medical Systems, Inc. | 2002 | — |
| +1 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| +2 | K081606 | Baha Intenso | Cochlear Americas | 2008 | — |
| +2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +2 | K082108 | Obc Bone Anchored Hearing Aid System | Oticon Medical AB | 2008 | — |
| +2 | K090996 | Ponto Pro | Oticon Medical AB | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K955713 | Nobelpharma Bone Anchored Hearing AidSummary page 2…Systems Classification LXB ESD LXB code K-number Pending ExemDt K955713 CROS = Contra-lateral Routing Of Signals 6. Discussion of testing A clinical study was conducted to establish the b… | 1996 |
| * | — | Air conduction hearing aids with a CROS unit Named without a submission number |
What descends from it? (40)
See all 403 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K042017 (Entific Medical Systems, Inc., 2004) has gone furthest, with 39 descendants of its own.
- 3 other devices also cite its predicate K955713.
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 use of BAHA hearing aid for SSD is intended to improve speech recognition.
The single sided deafness (SSD) indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1,2 and 3 kHz.
BAHA for SSD is also indicated for patients who are indicated for an AC CROS 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/K021837 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021837: Branenmark Bone-Anchored-Hearing Aid (Baha).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021837
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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