MED-EL USA announced the launch of the BCI 602, the second-generation implant for the BONEBRIDGE Bone Conduction Implant System at OSSEO2019: the 7th International Congress on Bone Conduction Hearing and Related Technologies in Miami Beach, Fla. BCI 602 availability is expected in January 2020.

BCI 602 was developed in partnership with ENT surgeons and features design optimizations to support a streamlined surgery. BCI 602’s BC-FMT (Bone Conduction Floating Mass Transducer) reportedly requires nearly 50% less drilling depth than the first-generation BCI 601 while still delivering “excellent hearing performance,” according to MED-EL. Self-drilling screws are said to “reduce the number of surgical steps needed,” and the implant and related parts are delivered together in one sterile kit, so professionals can “optimize their workflow in the operating room.”

According to MED-EL’s announcement, the smaller size also means that there are fewer anatomical restrictions for patients, and more candidates have the potential to benefit from this technology. Because the BC-FMT transducer is thinner, the implant requires a smaller bone area to become fixed upon. The implant is compatible with current and future audio processors. 

“MED-EL continues to live our mission of removing hearing loss as a barrier to communication and quality of life. We have led the industry in researching and designing new innovative technologies like the BONEBRIDGE BCI 602 that contribute to successful hearing outcomes for our recipients,” said Raymond Gamble, President & CEO, MED-EL North America. “BCI 602 is a success story as it integrates the valuable feedback from surgeons and hearing professionals into this next-generation device. Today’s launch is an exciting milestone for MED-EL as it validates the critical contributions of the hearing loss community in bringing new technologies to market.”

The BONEBRIDGE BCI 602 received a 510(k) clearance from the US Food and Drug Administration (FDA) in September 2019. It is indicated for individuals age 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.

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Source: MED-EL

Image: MED-EL