Cleared Traditional

K240614 - Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
(FDA 510(k) Clearance)

K240614 · Oticon Medical AB · Ear, Nose, Throat

Jul 2024

Decision

127d

Days

Class 2

Risk

K240614 is an FDA 510(k) clearance for the Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS. This device is classified as a Active Implantable Bone Conduction Hearing System (Class II — Special Controls, product code PFO).

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on July 10, 2024, 127 days after receiving the submission on March 5, 2024.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3340. 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..

Submission Details

510(k) Number	K240614 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2024
Decision Date	July 10, 2024
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PFO — Active Implantable Bone Conduction Hearing System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.3340
Definition	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.