BCI 602 Bone Conduction Implant | MED-EL Pro (2023)

Awarded 2019 to the BONEBRIDGE BCI 602 Bone Conduction Implant.

There are two main types of bone conduction: active and passive. Passive bone conduction uses mechanical amplification through the skin. This can be effective for conductive hearing loss, but some sound energy is lost as it passes through the skin. With active bone conduction, the mechanical sound energy is transferred directly to the bone for optimal sound quality and more powerful amplification.^[ft]

BONEBRIDGE uses a one-of-a kind fully implantable electromagnetic transducer. The transducer is anchored directly to the bone. This direct-drive amplification enables powerful, high quality sound transmission across the full range of frequencies.

• Immediate improvement at activation
• High benefit levels reached quickly
• Stable long-term benefit

Nearly 10 years ago, MED-EL revolutionized the field of bone conduction with the first generation BONEBRIDGE. Now, with thousands of successful cases and extensive published clinical literature, it’s safe to say that BONEBRIDGE BCI technology is here to stay.

The compact, energy efficient BC-FMT maximizes power-to-size ratio to deliver optimal hearing outcomes without compromising implant placement or battery life. The powerful floating-mass transducer enables effective amplification across the whole frequency spectrum—from the low frequencies for richness of sound to the high frequencies for better speech understanding.^[ft][ft]

Percutaneous and passive transcutaneous bone conduction systems usually integrate the mechanical transducer into the audio processor. However, if the microphones and mechanical transducer are combined into one audio processor, this can cause uncomfortable audio feedback. This can limit the effective amplification range of these designs.

BONEBRIDGE uses wireless signal transmission between the SAMBA 2 audio processor and the active implant. SAMBA 2’s dual microphones are separated from the mechanical output of the implant to minimize any issues with feedback, even at high gain levels.

By design, traditional percutaneous BAHA systems require a screw and abutment that permanently penetrates through the skin, causing a significant risk of infection and other skin complications. This can lead to user dissatisfaction or non-use of these percutaneous devices.^[ft]

With BONEBRIDGE, there’s no need for an abutment, so the skin between the audio processor can heal completely after the initial surgery. Using similar technology to our cochlear implants, the SAMBA 2 audio processor transmits sound information as fully wireless signals to the implant receiver coil. With nearly 10 years of clinical experience, it’s clear that BONEBRIDGE delivers superior outcomes compared to percutaneous bone anchored implants.^[ft]

There are intact-skin BAHA devices available. However, these passive bone conduction devices require magnetic pressure to transmit mechanical vibration to a passive implant. This can cause excessive discomfort and may significantly reduce wearing time, which would reduce overall hearing benefit.

In contrast, the SAMBA 2 audio processor for BONEBRIDGE is held in place with gentle magnetic attraction, because no force needs to be transmitted to the active implant. Weighing less than 9 grams, the sleek, low-profile SAMBA 2 is worn completely off the ear and easily disappears beneath hair. Together, SAMBA 2 and BONEBRIDGE deliver all-day comfort for the best hearing experience in everyday life.^[ft]

Flexible Surgical Placement

With an active bone conduction implant, it’s important to place the mechanical transducer as close to the cochlea as possible. However, you also need suitable anatomy to accommodate the implant. Lastly, it’s necessary to account for the placement of the receiver coil, as this corresponds to where the audio processor will be worn.

If an active bone conduction implant has a large transducer footprint, it may limit the placement options due to anatomical boundaries. Furthermore, if the transition between receiver coil and transducer has a rigid “monolith” design, then coil and audio processor placement is inflexible.

That’s why BONEBRIDGE uses a small implant footprint and flexible design that’s suitable for nearly any anatomy. With BCI 602, the flexible transition between receiver coil and the floating-mass transducer can bend up to 90 degrees in either lateral direction. The transition can also bend medially up to 30° to accommodate curvature of the skull. This gives you incredible flexibility in placing the both the implant transducer and the coil, enabling optimal outcomes across a wide range of anatomies.

With the 2nd generation BCI 602, we’ve reduced the drilling depth by nearly 50 percent compared to the previous generation—down to 4.5 mm. This puts the drilling depth on par with traditional bone conduction implants, without compromising performance or stability.

With a reduced drilling depth and small implant footprint, the BCI 602 can be flexibly placed in many positions on the temporal bone. The reduced drilling depth helps reduce risk of contacting the dura or other structures. It also helps broaden the range of suitable anatomies, making it especially useful in younger children.

~50%
Less Drilling Depth

BONEBRIDGE uses two titanium fixation wings to anchor the implant to the bone. This straightforward design makes it simple to secure the implant to the bone.

Even better, with the second generation BCI 602, we introduced self-drilling screws for easier implant fixation. This greatly simplifies surgical handling and enables a shorter, faster surgical procedure. Our new single-use BCI 602 Size Kit also simplifies surgical handling and clinical logistics.

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See the detailed steps for implanting BONEBRIDGE BCI 602.