# K200504: BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

- Pathway: 510(k) (Traditional)
- Applicant: Med-El Elektromedizinische Geraete GmbH
- Decided: Jul 29, 2020 after 149 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: 2 generations 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)
- K183373: Bonebridge, Med-El Elektromedizinische Geraete GmbH (2019) Summary page 6.

## 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 deafuess. 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, I, 2 and 3kHz) 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 JO dB on average measured at 0.5, I, 2 and 3kHz, 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 deafuess 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, I, 2 and 3kHz). - 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/K200504
Methodology: https://510kreport.com/methodology