BONEBRIDGE System Safety and Reliability
Our Philosophy
All our life-changing devices are developed with a complete 360-degree view of reliability and safety in mind. BONEBRIDGE, MED-EL’s active bone conduction implant system, is the most advanced active transcutaneous bone conduction system available on the market—and it’s no coincidence that BONEBRIDGE provides outstanding reliability.
We designed BONEBRIDGE with a broad understanding of what is needed to make a bone conduction implant system safe and reliable: a robust implant engineered to minimize complications, withstand impact, keep skin healthy, and allow easy access to MRI scans.* And all that comes with a reliable audio processor that makes everyday hearing simple for recipients.
We know your patients count on our technology to enjoy life every day. That’s why we made BONEBRIDGE safe and reliable by design.
BONEBRIDGE: Trusted
Longer Than Any Other
Leading innovation in hearing healthcare, MED-EL has shaped the future of implantable bone conduction hearing solutions by developing the first active transcutaneous bone conduction implant in the world—BONEBRIDGE.
Now the only active under-the-skin BCI with over a decade of clinical experience since 2012, thousands of recipients trust BONEBRIDGE to hear every day.
- 360° reliability by design
- Trusted by thousands worldwide
- Unmatched, long-term clinical experience since 2012
“Time allows a prosthesis to evolve based on the experience of users, audiologists, and surgeons, making it more reliable. Time and data are needed to demonstrate the reliability and validity of a device.”
Professor Mario E. Zernotti
National University of Villa Maria, Argentina
BCI 602 Implant: Outstanding Reliability
Commercially released in 2019, the second generation BONEBRIDGE implant evolved based on years of experience from users, surgeons, and audiologists, making it even more reliable.
The BCI 602 combines direct-drive amplification with proven transcutaneous technology in a streamlined design to offer an unmatched level of hearing performance, surgical flexibility, and user satisfaction.
.jpg?auto=format&sfvrsn=ddc38e43_0 "BCI 602")
Cumulative Survival Rates
MED-EL reporting on implant reliability and safety is compliant with International Standard ISO 5841-2:2014.[ft]
The cumulative survival rate of the second-generation BONEBRIDGE is 98.73% within 6 years.
MED-EL, Data on file as of July 1, 2026
What Makes MED-EL’s Hearing Implants So Reliable?
Listen to our podcast series to discover how we ensure that every MED-EL hearing implant meets the highest standards for quality, safety, and reliability.
Clinical Safety
While it is important for implant manufacturers to report reliability data openly, these reports only provide part of the picture. Clinic-reported data in peer-reviewed publications often give a more complete overview. These are especially useful when it comes to complications and adverse events associated with a device.
Impact Safety
We engineered BONEBRIDGE for impact resistance. A robust titanium design, stable two-point fixation, and a transducer embedded in the bone with low protrusion make BONEBRIDGE very reliable against impact.
- Stable two-point fixation
- Transducer recessed securely in bone
- Lower protrusion above the bone [ft][ft]
“Embedding the transducer has two main advantages. On the one hand, this increases the contact area with the bone, which increases the stability. And on the other hand, embedding also minimizes skin protrusion.”
Dr. Estefanía Berrocal
Otorhinolaryngologist in Spain
Securely Embedded in Bone
In contrast to other bone conduction implants, BONEBRIDGE is not simply placed on the bone’s surface and screwed in. Instead, the transducer of BONEBRIDGE is embedded in the bone, making it impact resistant.
In addition, BONEBRIDGE was designed with stable two-point fixation, making it very reliable against impact. On the other hand, many other devices are not embedded in the bone or are only secured at one point.
Skin Safety
BONEBRIDGE is designed to leave the skin over the implant intact. The implant is placed beneath the skin and the transducer transfers vibrations directly to the bone. This allows the skin to remain healthy.
- Intact Skin
- Minimized skin displacement
- No unsightly bulge
BONEBRIDGE Has Fewer Skin-Related Issues
The BCI 602 implant is rounded just as the human skull is. Compared to OSIA, BONEBRIDGE’s transducer has a smaller diameter and a sagittal profile to match the mastoid bone’s curvature. In addition, BONEBRIDGE’s transducer is partly recessed in a bone bed, which minimizes skin displacement.
The result? A systematic analysis including 1385 implantations reported significantly lower risks of minor events (on average 9.1 events per 100 patients per year) with BONEBRIDGE when compared to studies reporting on OSIA, which had an average of 25.8 events per 100 patients per year.[ft] Most of these complications were skin-related and included swelling, pain, redness, or transient wound infections.
MED-EL BONEBRIDGE BCI 602
COCHLEAR OSIA OSI300
Made for MRI
BONEBRIDGE’s advanced magnet technology enables its magnet to remain secure and free of force throughout MRI scans. This enables straightforward and easy access to MRI scans following the simple safety conditions—all without additional surgery and without hearing downtime.*
- The only BCI with a life-long guarantee
- No surgery
- No hearing downtime
Great Protection. Guaranteed.
Because of our long and positive experience with MRIs and hearing implants, we offer a life-long MRI guarantee. We promise to replace a BONEBRIDGE implant in the very unlikely event that it’s damaged during an MRI scan.
This life-long MRI guarantee for hearing implants is the first and only such guarantee to be offered by any hearing implant manufacturer. It covers both the BCI 601 and BCI 602 implants, so your patients can feel confident about any MRI scans they need in the future.
Audio Processor Reliability
An implant that delivers outstanding reliability would be no good without an audio processor that can also do the same. An audio processor that is reliable by design provides your patients with reliable hearing day after day. This also means there will be fewer visits to your clinic.
Low Average Monthly Repair Rate
The SAMBA 2 audio processor has a proven record of reliability. Introduced in 2020, SAMBA 2 is a small, sleek, and stylish audio processor that provides natural sound quality across the full range of frequencies.
Thanks to SAMBA 2’s superior battery life—longer than any other active BCI processor on the market—users can rely on it to access sound for more than one week from one battery.
SAMBA 2's average monthly repair rate is 1.39%.
“My BONEBRIDGE bone conduction implant and my SAMBA 2 audio processor have allowed me to have a future full of beautiful sounds. Thanks to them, I was able to start playing the cello and can do any sport I want without restrictions.”
Daniel,
BONEBRIDGE User From Spain
Active Bone Conduction Implants: Safety & Reliability Comparison
Your patients deserve devices that are safe and reliable by design. When choosing an active bone conduction implant, there are several important factors to keep in mind.
| BONEBRIDGE | Osia** | |
| Minimal skin strain thanks to ergonomic, rounded design [ft] | ||
| Implant transducer recessed in bone bed provides stability with a low profile [ft] | ||
| Proven electromagnetic transducer design | ||
| Secure, two-point fixation provides additional stability [ft][ft] | ||
| Unmatched, long-term clinical experience for over a decade [ft] |
MED-EL:
360° Reliability by Design
For more than 35 years, MED-EL has been a trusted partner and innovation leader in hearing implants. We create and manufacture our implants directly in our Austrian headquarters, ensuring they follow state-of-the-art European engineering, and meet the highest standards in quality and reliability. With this focused oversight and our dedication to quality, we can check and verify every single step of the design and manufacturing process.
MED-EL has always been privately owned by our founders, so for us reliability is not a percentage or an earnings report for investors. With no external shareholders to answer to, we’re in a unique position where we can put the safety and peace of mind of our recipients above all else. And because we believe that everyone should benefit from the latest hearing technology, our latest audio processors work for all our recipients since 1994.
Choosing MED-EL means putting your trust in us. We promise to always be there for you, our professional partner, and for your patients.
- European engineering
- Manufactured on-site
- Dedication to reliability and quality
- Unmatched backward compatibility
- Committed to recipients
Contact Us
Want to learn more about how BONEBRIDGE is reliable by design? Fill out the form below and a MED-EL representative will get in touch with you.
* The BONEBRIDGE BCI 601 and BCI 602 Active Bone Conduction Implants are MR Conditional. Recipients with BONEBRIDGE may be safely MRI scanned at 1.5 Tesla following the conditions detailed in the instructions for use.
** Osia is a trademark of Cochlear Ltd, Australia
