510(k) · Cleared
ClearedNobelpharma Bone Anchored Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Aug 9, 1996 as substantially equivalent to K945154 (Nobelpharma USA, Inc., 1995) and 2 other predicates after a 235-day review. Its family tree reaches back 1 generation to 1986. 45 later devices descend from it.
- Decided
- Aug 9, 1996
- Review
- 235 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K861971 (1986). 3 ancestors in all. 45 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- This deviceK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- Descendant · cites it directly · 43 of its ownK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- Descendant · cites it directly · 40 of its ownK021837 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 · cites it directly · 36 of its ownK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 35 of its ownK081606 Baha IntensoCochlear Americas · 2008
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999 · cites it directly43descendants
- K021837Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc. · 2002 · cites it directly40descendants
- K042017Baha DivinoEntific Medical Systems, Inc. · 2004 · cites it directly39descendants
- K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999 · cites it directly36descendants
- K081606Baha IntensoCochlear Americas · 2008 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| 0 (this device) | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| +1 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| +1 | K021837 | Branenmark Bone-Anchored-Hearing Aid (Baha) | Entific Medical Systems, Inc. | 2002 | — |
| +1 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| +1 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| +2 | K081606 | Baha Intenso | Cochlear Americas | 2008 | — |
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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 4 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945154 | BA-CpasSummary page 1…C. The Predicate Product The predicate pr:oduct used in this Premarket Notification is the BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Audiant Bone Conduction Hearing Aid | (K861971, K872168 and K841432), and other bone conduction hearing aids. === Page 2… | 1995 |
| * | K861971 | Xomed Audiant Bone Conductor W/Improved AA CoilSummary page 1…d in this Premarket Notification is the BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Audiant Bone Conduction Hearing Aid | (K861971, K872168 and K841432), and other bone conduction hearing aids. Center for Devices and Radiological Health Decem… | 1986 |
| * | K872168 | Xomed Audiant Bone Conductor at the Ear Sound Pro.Summary page 1…Premarket Notification is the BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Audiant Bone Conduction Hearing Aid | (K861971, K872168 and K841432), and other bone conduction hearing aids. Center for Devices and Radiological Health December 15, 19… | 1987 |
| Kept off the family tree | K841432 | Audiant Bone Conduction Hearing Aid Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…tification is the BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Audiant Bone Conduction Hearing Aid | (K861971, K872168 and K841432), and other bone conduction hearing aids. Center for Devices and Radiological Health December 15, 1995 Page -11… | |
| * | — | other bone conduction hearing aids Named without a submission number |
What descends from it? (45)
See all 454 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?
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 BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients requiring hearing amplification and with the following conditions: 1) Otological congenital malformations of the external ear or microtia chronically draining ear which does not allow use of an air conduction hearing aid (e.g. external otitis, draining mastoid cavity) 2) other acquired…
Read the full statement (295 words)
The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients requiring hearing amplification and with the following conditions:
1) Otological
congenital malformations of the external ear or microtia
chronically draining ear which does not allow use of an air conduction hearing aid (e.g. external otitis, draining mastoid cavity)
2) other acquired malformations of the middle or external ear which preclude the wearing of a conventional hearing aid
patients presently wearing, but dissatisfied with, traditional bone conduction hearing aids or patients who are satisfied with their bone conduction aids but could benefit from the features of the BAHA-type device.
patients with conductivgfi hearing loss due to ossicular disease and not appropriate for surgical correction or unable to be aided by conventional air conduction hearing devices.
Audiological
Pure tone average bone conduction threshold of the indicated ear better than or equal to 45 dB HL for model, Classic 300 and 60 dB HL for model HC-220 (average 500, 1k, 2k and 3k Hz); and a speech discrimination score better than 60% or reasonably good speech discrimination as evaluated by a qualified audiologist, based on the patient's particular needs.
3) Psychosocial
patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful cofisidcmfion must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. Patients should be at least 3 years of age.
4) Anatomical and Biologig*gl
Biologically, titanium implants can be installed in most patients. Sufficient bone volume and bone quality should be present for a successful fixture implantation. Alternative treatments should be considered for patients having a disease state that might jeopardize osseointegration.
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/K955713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955713: Nobelpharma Bone Anchored Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955713
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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