# K201983: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

- Pathway: 510(k) (Traditional)
- Applicant: Med-El Elektromedizinische Geraete GmbH
- Decided: Oct 9, 2020 after 84 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191457: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm), Med-El Elektromedizinische Geraete GmbH (2019) Summary page 4.
- DEN170009: Bonebridge, Med-El Elektromedizinische Geraete GmbH (2018) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K201983
Methodology: https://510kreport.com/methodology