# K240614: Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

- Pathway: 510(k) (Traditional)
- Applicant: Oticon Medical AB
- Decided: Jul 10, 2024 after 127 days
- Product code: PFO (Active Implantable Bone Conduction Hearing System)
- Device class: 2
- Regulation: 21 CFR 874.3340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170009 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170009: Bonebridge, Med-El Elektromedizinische Geraete GmbH (2018) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240614
Methodology: https://510kreport.com/methodology