510(k) · Cleared
ClearedSentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oticon Medical AB · PFO Active Implantable Bone Conduction Hearing System
Cleared on Jul 10, 2024 as substantially equivalent to DEN170009 (Med-El Elektromedizinische Geraete GmbH, 2018) after a 127-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jul 10, 2024
- Review
- 127 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170009 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- This deviceK240614 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB · 2024
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) | K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | 2024 | — |
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.
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN170009.
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. 2024, 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 Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients: Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL. * Patients having a symmetrically conductive or mixed hearing loss are candidates for a…
Read the full statement (230 words)
The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:
Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.
* Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. 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 a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
* Patients who are 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 has experience with appropriately fitted air conduction or bone conduction hearing aids.
* Patients 12 years of age or older.
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/K240614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240614: Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240614
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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