510(k) · Cleared
ClearedBranemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · MAH Hearing Aid, Bone Conduction, Implanted
Cleared on Jun 28, 1999 as substantially equivalent to K945154 (Nobelpharma USA, Inc., 1995) and 3 other predicates after a 221-day review. Its family tree reaches back 2 generations to 1986. 43 later devices descend from it.
- Decided
- Jun 28, 1999
- Review
- 221 days
- Class
- Class II
- Product code
- MAH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K861971 (1986). 4 ancestors in all. 43 later devices descend from it, 2 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 deviceK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 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
- Descendant · 2 generations on · 35 of its ownK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- Descendant · 2 generations on · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- 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
- K080363Baha Cordelle IICochlear Bone Anchored Systems AB · 2008 · 2 generations on35descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · 2 generations on33descendants
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) | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| +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 | — |
| +2 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| +2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems 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 |
|---|---|---|
| 1999 | 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 MAH? 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 MAH device
- #1 K261142 Ponto 5 Mini; Ponto 5 Superpowerscore 15.2 · 12 generations · no Class I recall
- #2 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…er. The Predicate Product The predicate product used in this Premarket Notification is the Branemark System® . Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Brane- mark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hear- ing Aid (K861971, K872168 and K841432),… | 1995 |
| * | K955713 | Nobelpharma Bone Anchored Hearing AidSummary page 1…d in this Premarket Notification is the Branemark System® . Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Brane- mark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hear- ing Aid (K861971, K872168 and K841432), and other bone-conduction hearing aids. Description… | 1996 |
| * | K861971 | Xomed Audiant Bone Conductor W/Improved AA CoilSummary page 1…em® . Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Brane- mark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hear- ing Aid (K861971, K872168 and K841432), and other bone-conduction hearing aids. Description of Device The Branemark Bone~Anchored Hearing Aid (B… | 1986 |
| * | K872168 | Xomed Audiant Bone Conductor at the Ear Sound Pro.Summary page 1…e-Anchored Craniofacial Prosthetic Attachment System (K945154), the Brane- mark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hear- ing Aid (K861971, K872168 and K841432), and other bone-conduction hearing aids. Description of Device The Branemark Bone~Anchored Hearing Aid (BAHA) Syst… | 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…raniofacial Prosthetic Attachment System (K945154), the Brane- mark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hear- ing Aid (K861971, K872168 and K841432), and other bone-conduction hearing aids. Description of Device The Branemark Bone~Anchored Hearing Aid (BAHA) System includes… |
What descends from it? (43)
See all 432 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 13 years and passes through 2 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.
- 4 other devices also cite its predicate K945154.
How does its category compare?
All MAH devicesMAH Hearing Aid, Bone Conduction, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MAH
124in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAH
No recall names MAH since 2007.
Adverse event reports per year · MAH
562in 2025
MAUDE reports naming product code MAH, 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 | 9 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 3 | 124 | 0 | 52 |
| 2016 | 1 | — | 0 | 309 |
| 2017 | 0 | — | 0 | 614 |
| 2018 | 1 | — | 0 | 629 |
| 2019 | 0 | — | 0 | 635 |
| 2020 | 0 | — | 0 | 692 |
| 2021 | 1 | — | 0 | 709 |
| 2022 | 0 | — | 0 | 711 |
| 2023 | 0 | — | 0 | 742 |
| 2024 | 0 | — | 0 | 621 |
| 2025 | 0 | — | 0 | 562 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification- Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each…
Read the full statement (358 words)
This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification- Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:
1. Chronic otitis media (COM); or
2. Congenital malformation (CM) of the middle/external ear; or
3. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
Additional indications to be met by perspective BAHA candidates:
1. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient’s psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
2. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.
Contraindications:
1. Speech discrimination scores of the indicated ear less the 60% at elevated sound pressure levels (SPL) during standardized tests.
2. Patients who are developmentally delayed or who suffer from drug abuse. (This includes children who have behavior problems or who have parents who are not able to keep the implanted area clean.)
3. Age less than 5 years.
4. Patients who already have a BAHA (i.e. no bilateral implants.) The BI-CROS attachment to the BAHA should be used for this purpose.
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/K984162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984162
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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