# K191457: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

- Pathway: 510(k) (Traditional)
- Applicant: Med-El Elektromedizinische Geraete GmbH
- Decided: Sep 18, 2019 after 110 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K201983: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (2020), 0 descendants of its own

## Indications for use
INTENDED USE: The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness. INDICATIONS: The Bonebridge bone conduction hearing implant 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 45 dB HL. - Bilateral fitting of the Bonebridge 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 Bonebridge 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 has experience with appropriately fit air conduction or bone conduction hearing aids. CONTRAINDICATIONS: - Chronic or non-revisable vestibular or balance disorders. - Abnormally progressive hearing loss. - Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment. - Skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with the use of the audio processor. -Skull size or abnormality that would preclude appropriate placement of the Bonebridge implant as determined by CT scan.

Source page: https://510kreport.com/device/K191457
Methodology: https://510kreport.com/methodology