Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
FDA 510(k) K240614 · Oticon Medical AB
Submission
- Device name
- Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
- Applicant
- Oticon Medical AB
Askim, SE - Received
- March 5, 2024
- Decision date
- July 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PFO – Active Implantable Bone Conduction Hearing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3340
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
Other 510(k)s with product code PFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3…PFO · Traditional | Cochlear Americas | 07/10/2026SE |
| K240155 | Cochlear Osia SystemPFO · Traditional | Cochlear Americas | 04/18/2024SE |
| K231204 | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette…PFO · Traditional | Cochlear | 08/18/2023SE |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…PFO · Traditional | Cochlear Americas | 07/27/2022SE |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)PFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 10/09/2020SE |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemotePFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 07/29/2020SE |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…PFO · Traditional | Cochlear Americas | 11/15/2019SE |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit…PFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 09/18/2019SE |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…PFO · Traditional | Cochlear Americas | 07/03/2019SE |
| K183373 | BonebridgePFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 03/07/2019SE |
More from Med-El Elektromedizinische Geraete GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 SuperpowerMAH · Special | 08/26/2026SE |
| K213733 | Ponto 5 SuperPowerLXB · Special | 12/16/2021SE |
| K211640 | Ponto 5 MiniLXB · Special | 08/10/2021SE |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery KitMAH · Special | 03/03/2021SE |
| K190540 | Ponto 4LXB · Traditional | 05/02/2019SE |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerLXB · Traditional | 09/29/2016SE |
| K152820 | Ponto Bone Anchored Hearing SystemMAH · Traditional | 01/22/2016SE |
| K152067 | Ponto bone anchored hearing systemMAH · Traditional | 11/23/2015SE |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…MAH · Traditional | 01/21/2015SE |
| K141616 | Sterilization CassetteKCT · Traditional | 09/23/2014SE |
Questions and answers
When was Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS cleared by the FDA?
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614) received a 510(k) decision of Substantially Equivalent on July 10, 2024, 127 days after the submission was received.
What is the product code of K240614?
The FDA product code is PFO – Active Implantable Bone Conduction Hearing System, a Class II (moderate risk) device regulated under 21 CFR 874.3340.