510(k) · Cleared
ClearedCochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear · PFO Active Implantable Bone Conduction Hearing System
Cleared on Aug 18, 2023 as substantially equivalent to K220922 (Cochlear Americas, 2022) after a 113-day review. Its family tree reaches back 4 generations to 2018. 2 later devices descend from it.
- Decided
- Aug 18, 2023
- Review
- 113 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170009 (2018). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- 3 generations backK190589 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia…Cochlear Americas · 2019
- 2 generations backK191921 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia…Cochlear Americas · 2019
- 1 generation backK220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia…Cochlear Americas · 2022
- This deviceK231204 Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™…Cochlear · 2023
- Descendant · cites it directly · 1 of its ownK240155 Cochlear Osia SystemCochlear Americas · 2024
- Descendant · 2 generations on · 0 of its ownK260902 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound…Cochlear Americas · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| −3 | 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 | — |
| −1 | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound… | Cochlear Americas | 2022 | — |
| 0 (this device) | K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet… | Cochlear | 2023 | — |
| +1 | K240155 | Cochlear Osia System | Cochlear Americas | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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 13.1 · 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 |
|---|---|---|---|
| * | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…Summary page 5…R 874.3340, Class II Classification Panel: Ear, Nose, and Throat Product Code: PFO 510(k): K220922 E. Purpose of Submission This Traditional 510(k) seeks clearance for an updated Osia System, which includes a new OSI300 Implant… | 2022 |
| † | K100360 | BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment | 2010 |
| † | K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240155 | Cochlear Osia System | 2024 | 1 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240155 (Cochlear Americas, 2024) has gone furthest, with 1 descendant 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. 2023, 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/K231204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231204: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231204
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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