Get the App

FDA Approves PULSAR, SONATA, CONCERT

Manufacturing Group | June 19, 2013

MED-EL Cochlear Implants for use with 1.5 Tesla (T) MRI systems without the need for surgical removal of the internal magnet.

FDA Approves PULSAR, SONATA, CONCERT

MED-EL USA officials announced the U.S. Food and Drug Administration (FDA) approval of the PULSAR, SONATA and MED-EL CONCERT cochlear implants for use with 1.5 Tesla (T) MRI systems without the need for surgical removal of the internal magnet. MED-EL’s cochlear implants are the only implants available in the United States with this approval. Patients with one of these MED-EL cochlear implants will be able to obtain 1.5T MRI scans upon final labeling approval by FDA, expected by the end of summer 2013.

Magnetic Resonance Imaging (MRI) capability is an important issue for people who have cochlear implants. The FDA approval for MRI imaging at 1.5T without the surgical removal of the magnet is a major breakthrough for people who live with chronic conditions, such as heart disease, cancer, and neuromas that may require the regular use of MRI technology. All MED-EL cochlear implants have been FDA approved for 0.2T scans without surgical removal of the magnet since 2001. The addition of 1.5T MRI means that physicians will be able to obtain even higher resolution imaging, allowing better diagnosis and treatment using the most popular scan resolution currently used in the United States.

Pete Unger, a member of MED-EL’s Patient Support Team, is one such case. After having surgery to remove a tumor in 2004, Unger’s doctors recommended periodic MRIs to monitor the area where his tumor was removed. The surgery left Unger completely deaf on his right side and he soon lost most of his hearing on his left side due to Meniere’s disease. Unger says that MRI capability without magnet removal was a primary reason why he chose a MED-EL implant in 2007. 

“It’s reassuring to know that my MED-EL implant has not only given me my hearing back, but has now given me peace of mind during my follow up care,” he adds.

Patients with other brands of cochlear implants must have surgery to remove the internal magnet before undergoing an MRI scan and a second surgery is required to replace the magnet after the scan has been obtained. Even surgeries described as “minimally invasive” can cause pain and discomfort, come with an increased risk of surgical side effects such as scarring, and add unnecessary cost from the surgery (including a new, sterile magnet) and lost wages during recovery. Because no additional surgery is necessary for MED-EL’s implant users to receive an MRI, there is also no time, aside from actually receiving the MRI, when the recipient needs to go without their audio processor (which must be removed for MRI scanning).

MRI machines are available in a range of strengths, called Tesla (T). The current standard strength is 1.5T in the United States and the vast majority of MRIs performed are done with 1.5T machines. More than 32 million MRIs were performed in the USA in 2011.(IMV)Recent data show that MRI use in the United States has increased by approximately 10% annually between 1996 and 2010.(JAMA)

People who have a MED-EL PULSAR, SONATA or MED-EL CONCERT cochlear implant will not need special permission from the company prior to undergoing an 1.5T MRI; warranties for internal equipment will continue to be valid as long as the company’s recommendations for scanning are followed. These recommendations will be available on the company’s website in the near future. It is important to note that all cochlear implants, including those manufactured by MED-EL, remain contraindicated for MRIs at 3.0T strength in the United States. 

While other manufacturers may claim MRI compatibility, MED-EL is the only company that has received FDA approval for patients to undergo 1.5T MRIs without additional surgery to remove the magnet.

You May Also Like

comments powered by Disqus