Optimized active transcutaneous technology with award-winning design available early 2020
December 11, 2019 – (DURHAM, NC) – MED-EL USA announced today the launch of the BCI 602, the second generation implant for the revolutionary 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) requires nearly 50% less drilling depth than the first generation BCI 601 while still delivering excellent hearing performance. Self-drilling screws 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.
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 and users can enjoy unparalleled wearing comfort and clear sound quality.
“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 technology 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 U.S. Food and Drug Administration 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.
For more information about BONEBRIDGE or any of MED-EL’s hearing solutions, visit https://www.JourneytoBetterHearing.com/.
About Conductive/Mixed Hearing Loss and Single-Sided Deafness
Conductive hearing loss is caused by problems with the ear canal, ear drum, or middle ear and its tiny bones (the malleus, incus, and stapes). Causes of conductive hearing loss include congenital absence of the ear canal or failure of the ear canal to be open at birth, and congenital absence, malformation, or dysfunction of the middle ear structures. Conductive hearing loss can also be caused by infection, tumors, middle ear fluid from infection or Eustachian tube dysfunction, a foreign body, trauma (as in a skull fracture), and otosclerosis.1 Mixed hearing loss is a combination of a sensorineural and conductive hearing loss. It results from problems in both the inner and outer or middle ear. Single-sided deafness (SSD) is a condition of profound unilateral sensorineural hearing loss, with normal hearing in the better hearing ear. SSD is a severe impairment that makes it hard to understand speech and sounds especially in noisy environments, as well as causes difficulty in determining the direction of a sound's location.
In 2018, MED-EL USA launched the country’s first active transcutaneous bone conduction implant, BONEBRIDGE, marking the beginning of a new era in bone conduction implants. BONEBRIDGE offered a groundbreaking solution in comparison to other technology, which meant that screws no longer needed to be applied through the skin, and that skin was left intact. BONEBRIDGE directly stimulates the bone, providing great sound quality without feedback. The BCI 602 has been developed through a long and valued partnership with ENT surgeons, hearing health professionals and the hearing loss community. Through this relationship, it was possible for MED-EL to improve the active transcutaneous bone conduction implant and develop the next generation. In 2019, MED-EL received the prestigious Red Dot Award for the design of the BCI 602 implant. The jury recognized the ergonomic design of the implant and how this could benefit future patients.
MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first microelectronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has grown to more than 2,000 employees and 30 locations worldwide.
The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 123 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined Electric Acoustic Stimulation hearing implant system as well as surgical and non-surgical bone conduction systems. www.medel.com
Rebecca Novak Tibbitt
Rebecca [at] RNTCommunications.com
Ph: (704) 341-1544