510(k) · Cleared
ClearedCochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · PFO Active Implantable Bone Conduction Hearing System
Cleared on Jul 3, 2019 as substantially equivalent to DEN170009 (Med-El Elektromedizinische Geraete GmbH, 2018) after a 118-day review. Its family tree reaches back 1 generation to 2018. 5 later devices descend from it.
- Decided
- Jul 3, 2019
- Review
- 118 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170009 (2018). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- This deviceK190589 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia…Cochlear Americas · 2019
- Descendant · cites it directly · 4 of its ownK191921 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia…Cochlear Americas · 2019
- Descendant · 2 generations on · 3 of its ownK220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia…Cochlear Americas · 2022
- Descendant · 3 generations on · 2 of its ownK231204 Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™…Cochlear · 2023
- Descendant · 4 generations on · 1 of its ownK240155 Cochlear Osia SystemCochlear Americas · 2024
- Descendant · 5 generations on · 0 of its ownK260902 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound…Cochlear Americas · 2026
Most influential descendants
Showing 5 of 5 · See all- K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…Cochlear Americas · 2019 · cites it directly4descendants
- K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…Cochlear Americas · 2022 · 2 generations on3descendants
- K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette…Cochlear · 2023 · 3 generations on2descendants
- K240155Cochlear Osia SystemCochlear Americas · 2024 · 4 generations on1descendant
- K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3…Cochlear Americas · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| 0 (this device) | K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia… | Cochlear Americas | 2019 | — |
| +1 | K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting… | Cochlear Americas | 2019 | — |
| +2 | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound… | Cochlear Americas | 2022 | — |
| +3 | K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet… | Cochlear | 2023 | — |
| +4 | K240155 | Cochlear Osia System | Cochlear Americas | 2024 | — |
| +5 | K260902 | Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound… | Cochlear Americas | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 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 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN170009 | BonebridgeSummary page 5…Ear, Nose, and Throat Product Code: PFO 1 510(k): DEN170009 E. Purpose of Submission This Traditional 510(k) seeks clearance for an active implantable bone conduction hearing system, known… | 2018 |
| † | P970051 | Nucleus 24 Cochlear Implant System | 1998 |
| † | K100360 | BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software… | 2019 | 4 |
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 PFO devicesPFO Active Implantable Bone Conduction Hearing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Osia 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 55 dB HL. • Bilateral fitting of the Osia System is intended for patients having a symmetrically conductive or mixed…
Read the full statement (232 words)
The Osia 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 55 dB HL.
• Bilateral fitting of the Osia System 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 Osia System 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 fitted air conduction or bone conduction hearing aids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190589: Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190589
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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