Advanced Bionics (AB) is currently receiving global approval of their HiRes™ Ultra 3D Cochlear Implant. This new cochlear implant (CI) device allows patients to have uninhibited access to an MRI scan.
1 in 10 patients undergo an MRI scan every year in most developed markets.1 Given that CI recipients suffer from sensorineural hearing loss, these users are at an increased risk of additional inner ear issues that will require an MRI scan at some point in their lifetime. This, combined with the fact that MRIs are becoming much more prevalent as a diagnostic tool for other health complications, means that MRI compatibility is a factor for all CI recipients.
MRIs are often available with two levels of strength - 1.5T and 3.0T. AB’s previous implant generation is compatible with a 1.5T MRI (provided the clinician wraps the patient’s head per a defined protocol). With a trend towards 3.0T over 1.5T MRI systems, and the complications that arise from MRIs with a conventional magnet system (80% of MRI related complications involved patients treated with a head wrap2, 70% of the time, MRIs with CI implants result in pain3, and head wrapping resulted in around 50% of patients having some sort of magnet dislocation.4) the unfilled clinical need is clearly shown.
With the HiRes™ Ultra 3D, we have placed 4 magnet cylinders in a diamond-like carbon (DLC) coated titanium frame that sits within titanium case halves. The case halves are laser seam welded together to create a hermetic seal and enclose the magnet assembly. The DLC coating on the frame reduces the friction and wear on the magnets during day-to-day use, and the frame itself provides superior impact resistance compared to all other cochlear implants on the market. Historically, magnets typically crack around 2 to 3 Joules of impact but with the 3D magnet, we achieve 7 to 8 Joules of impact before we start seeing damage.
The magnets within the frame are free to rotate in two dimensions: the magnets rotate around the titanium case’s central axis, and around their own magnetic axis. With this, the magnets can self-align to the MRI field, lowering the risk of pain as magnet torque is reduced to almost zero. While competitors may have their own, disc-shaped magnet solutions that can rotate with one degree of freedom, AB’s unique solution, with an additional degree of freedom, means that there are no head orientation restrictions in the MRI field. Additionally, the number of MRI cycles the patient can undergo without any loss of magnet strength or damage to the mechanism is far greater than our competitor’s.
We have heard testimonials from our patients that they had completely pain-free MRIs and clinicians have said that it was much easier providing their patients with access to an MRI when they don’t have to worry about head wrapping protocols or a surgery. The HiRes™ Ultra 3D is a game changing innovation in CI magnet technology with unmatched performance and a significant clinical future market.