De Novo · Granted
GrantedBonebridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-El Elektromedizinische Geraete GmbH · PFO Active Implantable Bone Conduction Hearing System
Granted on Jul 20, 2018 as a new device type through De Novo after a 522-day review. 10 later devices descend from it.
- Decided
- Jul 20, 2018
- Review
- 522 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
10 later devices descend from it, 4 citing it directly.
- This deviceDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- Descendant · cites it directly · 5 of its ownK190589 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia…Cochlear Americas · 2019
- Descendant · 2 generations on · 4 of its ownK191921 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia…Cochlear Americas · 2019
- Descendant · 3 generations on · 3 of its ownK220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia…Cochlear Americas · 2022
- Descendant · 4 generations on · 2 of its ownK231204 Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™…Cochlear · 2023
- Descendant · 5 generations on · 1 of its ownK240155 Cochlear Osia SystemCochlear Americas · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…Cochlear Americas · 2019 · cites it directly5descendants
- K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…Cochlear Americas · 2019 · 2 generations on4descendants
- K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…Cochlear Americas · 2022 · 3 generations on3descendants
- K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette…Cochlear · 2023 · 4 generations on2descendants
- K240155Cochlear Osia SystemCochlear Americas · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| +1 | K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia… | Cochlear Americas | 2019 | — |
| +2 | K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting… | Cochlear Americas | 2019 | — |
| +3 | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound… | Cochlear Americas | 2022 | — |
| +4 | K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet… | Cochlear | 2023 | — |
| +5 | K240155 | Cochlear Osia System | Cochlear Americas | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 PFO? 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 PFO device
- #1 K260902 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™…score 13.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test… | 2019 | 5 |
| K183373 | Bonebridge | 2019 | 1 |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | 2024 | 0 |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | 2020 | 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?
- Of its descendants, K190589 (Cochlear Americas, 2019) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PFO devicesPFO Active Implantable Bone Conduction Hearing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PFO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PFO
114in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PFO
No recall names PFO since 2007.
Adverse event reports per year · PFO
994in 2025
MAUDE reports naming product code PFO, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 4 | 114 | 0 | 25 |
| 2020 | 2 | — | 0 | 70 |
| 2021 | 0 | — | 0 | 237 |
| 2022 | 1 | — | 0 | 306 |
| 2023 | 1 | — | 0 | 473 |
| 2024 | 2 | — | 0 | 712 |
| 2025 | 0 | — | 0 | 994 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: Patients 12 years of age or older. Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL. Bilateral fitting of the BONEBRIDGE is intended for patients having a…
Read the full statement (228 words)
The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications:
Patients 12 years of age or older.
Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
The BONEBRIDGE 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.
Prior to receiving the device, it is recommended that an individual have experience with appropriately fit air conduction or bone conduction hearing aids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170009: Bonebridge.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170009
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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