The R&D Blog is a forum for manufacturers to share their latest research and news, but more importantly is a place for readers to comment and discuss new developments with them. Above all, it is a forum for opinions, questions, and discussions about hearing aid technology between manufacturers and hearing healthcare professionals.
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Monday, May 4, 2015
By Darla Franz, MA, & Rebecca Novak Tibbitt, MPH
Cochlear implants (CIs) are an increasingly common option for people with severe to profound hearing loss. Approximately 324,200 people worldwide had received implants as of December 2012, according to the U.S. Food and Drug Administration (FDA). In the United States, an estimated 58,000 adults and 38,000 children have received cochlear implants (National Institute on Deafness and Other Communication Disorders; bit.ly/NIDCD-CI
). Recent research has shown that the number of older adults in the United States who are potential candidates for cochlear implantation is approximately 150,000 and will continue to increase with the aging of the population (Medicine 2012;91:229-241
The development and improvement of advanced diagnostic imaging technologies is widely credited with leading to earlier and more accurate diagnoses of disease using noninvasive techniques. The use of diagnostic imaging, including MRI, has grown significantly in the Medicare population over the last two decades (JAMA 2012;307:2400-2409
One study of large health systems found that MRI use increased from 17 to 65 per 1,000 enrollees between 1996 and 2010, amounting to a 10-percent annual growth (JAMA 2012;307:2400-2409
). According to IMV’s 2014 MR Market Outlook Report, an estimated 34.9 million magnetic resonance (MR) procedures were performed in the United States in 2014 (bit.ly/IMV-MRI
). Today, the United States performs the most MRIs per 1,000 inhabitants out of any country in the Organization for Economic Cooperation and Development (OECD; bit.ly/OECD-MRI
MRI is utilized to diagnose a number of chronic conditions and diseases of aging such as heart disease, cancer, and neurodegenerative diseases. These conditions may require years of follow-up and continuous monitoring. Since current life span estimates are nearing 80 years (Centers for Disease Control and Prevention; bit.ly/CDC-LifeExpectancy
), it’s reasonable to expect that most children born today will undergo at least one MRI in their lifetime. With age comes the greater possibility for numerous MRI tests.
MRIs IN COCHLEAR IMPLANT PATIENTS
The intersection of an aging population, an increased reliance on MRI technology, and a growing acceptance of cochlear implantation among older adults raises the issue of implantable device compatibility with MRI and related practical concerns. MRI compatibility can be an afterthought for people who receive cochlear implants, particularly those who enjoy relatively good health at the time of implantation. However, hearing health professionals can provide a service to their patients by discussing the subject prior to the initial implant surgery.
The primary issue for patients with CIs who undergo MRI is exposure of the internal magnet to a strong electromagnetic field, which can induce significant magnetic forces and serious problems (JAMA Otolaryngol Head Neck Surg 2015;141:45-52
). The internal magnet located within the implant can generate significant torque when placed in a strong electromagnetic field, possibly dislodging the magnet. A less dramatic but still important concern is that the implant’s magnet can induce artifacts in MRI scans, whereas artifacts caused by the receiver coil and electrode are comparably small.
The FDA has allowed the use of MRI on patients with CIs in specific cases under certain conditions of use. For example, in 2013, MED-EL implants SONATA, PULSAR, and CONCERT, which do not have removable magnets, were approved for use with MRI instruments involving a field strength of 1.5 tesla (T), with the condition that head dressings were used, along with other requirements related to the position of the patient within the scanner and the type of scanning sequences utilized. CIs with removable magnets were approved for use with MRI systems up to 1.5 T following the surgical removal of the internal magnet (JAMA Otolaryngol Head Neck Surg 2015;141:45-52
Surgical removal of the internal magnet involves risks and quality-of-life considerations. From a practical standpoint, the surgery center may not be in the same location as the MRI center. Scheduling surgery on the same day as an MRI can add a layer of logistical complication for a patient in terms of anesthesia and transportation. Additionally, surgical removal of the magnet means that MRIs are effectively precluded from emergency situations.
While the CI magnet is out, the patient can’t hear, which is a practical concern for CI users undergoing MRI. The time frame from surgery, to MRI, to the insertion of a sterile new replacement magnet is one to three days in a best-case scenario. The out-of-pocket costs of the two surgeries (magnet removal and replacement) adds to the financial impact of time off work and the cost of the MRI scan itself.
In one study of 18 CI patients who had an MRI, complications included extreme pain; pain severe enough to stop the MRI, resulting in an incomplete image; internal magnet displacement; and even polar reversal of the magnet. Large artifacts in the regions surrounding the implants were another concern.
“Overall, none of the patients showed displaced electrodes, demagnetized magnets, or any significant changes in auditory performance,” the study authors wrote. “However, due to several procedures involving magnet removal, magnet insertion, and CI reimplantation, [one] patient developed a postoperative wound infection requiring treatment with antibiotic medication and aseptic dressing.” None of the three patients with MED-EL implants reported adverse events (JAMA Otolaryngol Head Neck Surg 2015;141:45-52
THE NEW SYNCHRONY CI
In January, MED-EL USA announced that the FDA approved the new SYNCHRONY cochlear implant. For the first time, a cochlear implant has been approved as MR conditional for use with 3.0 T MRI without the surgical removal of the internal magnet.
SYNCHRONY features a patented new magnet design: a magnet with special diametric magnetization is encased in a titanium housing. During an MRI, SYNCHRONY’s magnet freely rotates and self aligns within its titanium housing, greatly reducing implant torque and the risk of demagnetization during MRI scans. This design enables high resolution 3.0-T MRI scans without magnet removal. The conical design of the removable magnet housing also greatly reduces the risk of magnet dislocation or migration. The implant features a polymer stiffening ring within the silicone implant body to further secure the magnet housing.
In the rare case that the implant magnet needs to be removed, such as for a brain MRI on the side of the implant, SYNCHRONY’s magnet housing can be removed and substituted with a nonmagnetic spacer for MRI head scans with minimal image distortion in the implant area. The removable magnet housing has a protective coating to prevent unwanted cellular adhesion, simplifying the removal and replacement of the implant magnet. The incision for magnet exchange is made beside the implant, rather than directly over the implant, shortening the period of interrupted hearing post-MRI.
As always, MED-EL strives to offer the highest technology that can be customized to each person with their unique hearing loss set against their unique life. MRI compatibility is one more advancement that preserves recipient quality of life. With the SYNCHRONY implant, users can keep pace with state-of-the-art diagnostics without the worry, cost and discomfort associated with additional surgery.
For more information about SYNCHRONY’s cochlear implant design, visit medel.com
Ms. Franz is vice president of education and corporate communications at MED-EL USA. Ms. Novak Tibbitt is a writer and health communications consultant for MED-EL.
Tuesday, October 8, 2013
By Lindsay Prusick, AuD
Education & Training Audiologist, Starkey Hearing Technologies
It affects 10 percent of Americans, no one has the same experience, and it does not discriminate. Can you guess what I am talking about? Tinnitus! The topic of tinnitus has become all the buzz.
Tinnitus is the perception of sound in one or both ears, or in the head, when no external sound is present. The sound is real, but no one except the patient hears it.
Researchers and clinicians have worked for decades to figure out the treatment or combination of treatments that can provide relief to patients with tinnitus. However, to date, no one specific treatment has been shown to work for every patient. Fortunately, there are a number of treatment options that have consistently been shown to help.
When Starkey Hearing Technologies set out to develop a tinnitus management technology, we made it a priority to take into consideration clinical research evidence, current tinnitus management protocols, and the needs of tinnitus patients and hearing healthcare professionals.
We recently released Multiflex Tinnitus Technology in Xino Tinnitus, a discreet receiver-in-canal (RIC) 10 device that is the smallest standard hearing aid Starkey currently offers. It provides 12 channels for programming the hearing aid response and 16 bands for shaping the tinnitus stimulus.
Xino Tinnitus is available in up to a 70-gain receiver and comes packed with our reliable and robust advanced features, including Spectral iQ, InVision Directionality, Voice iQ2, and, most notably, Multiflex Tinnitus Technology, which incorporates the elements of sound therapy, amplification, education, and personalization to provide patients with tinnitus relief.
Sound therapy has been shown to provide relief to many who have tinnitus. Sound therapy refers to the use of sound, such as noise, music, and relaxation sounds, to decrease the prominence of tinnitus. The sound can be set to a level that partially or fully masks tinnitus.
Multiflex Tinnitus Technology offers a white noise stimulus that can be enabled on a per memory basis. The stimulus can either be steady state or modulated, which provides a breeze or wavelike sound quality to the tinnitus stimulus.
Hearing aids have been shown in many studies to provide relief from tinnitus to individuals who have both tinnitus and hearing loss. This relief may occur for a number of reasons but is most commonly attributed to the fact that hearing aids amplify ambient background sounds, which, in turn, may partially or fully mask the ringing sounds of tinnitus.
It’s important to note that while Xino Tinnitus is a fully functioning hearing aid, it has been cleared by the Food and Drug Administration for use with tinnitus patients who have normal hearing, as it can be programmed to function as a sound generator only.
Simply educating patients about tinnitus, such as its prevalence, known triggers, and treatment options, can provide initial relief. Individualized counseling personalizes treatment and can help individuals better manage their tinnitus, setting them up for long-term success.
Starkey Hearing Technologies provides a number of AudiologyOnline courses
to teach professionals about the counseling and educational aspects of working with patients who have tinnitus. We also provide a number of online resources at starkeypro.com/tinnitus
A very important part of tinnitus treatment is personalization. Since every patient has different needs and a different tinnitus experience, it is extremely important that professionals personalize treatment to yield patient-perceived benefit and relief.
Multiflex Tinnitus Technology offers a “Best Fit” tinnitus stimulus algorithm that shapes the stimulus based on the patient’s audiometric configuration, providing immediate personalization in the fitting of the device as well as an excellent starting point for professionals.
One of most singular features of Multiflex Tinnitus Technology is SoundPoint Tinnitus, which provides the tinnitus patient the ability to work with the professional during the fitting process to fine-tune and individualize relief to their exact specifications.
Millions of Americans have tinnitus, and Starkey Hearing Technologies now offers a tinnitus management option for professionals. For more information and to get the Multiflex Tinnitus Technology experience, including a SoundPoint Tinnitus demo, please go to starkeypro.com/tinnitus
Wednesday, August 28, 2013
By Caitlin E. Veri
Communications Coordinator, EarQ
One of Colleen Van Rooy’s earliest memories is touching her family’s television/stereo cabinet to feel the sound moving through it. As a child born with hearing loss, that was the only way the Appleton, WI, native could experience sound.
But things soon changed when Colleen received her first pair of hearing devices at the age of 4. From that moment on, Colleen was unstoppable. From academics to community service, Colleen has never missed a step. Today, as she raises three children who also have hearing loss, Colleen continues to exemplify determination as she tackles any obstacle that stands in her way.
Colleen is just one of the many individuals in our society who overcame hearing loss to live a well-rounded and successful life. In a society that wrongly equates hearing loss with weakness, a revolutionary foundation is primed to shatter stereotypes and empower the millions of people with untreated hearing loss to take action.
The HearStrong Foundation will radically challenge the general perception of hearing loss in our society today by celebrating individuals worldwide who have not only faced hearing loss but conquered it with a determined spirit, a focused mind, and an unwavering heart. Known as HearStrong Champions, these men, women, and children are the cornerstone of the foundation, which is funded through the generosity of EarQ providers. People will nominate friends, coworkers, and family members who have refused to let hearing loss deter them from their goals to be named an official HearStrong Champion.
Once selected by the foundation, each champion is awarded a gold medal and certificate. Many will receive a ceremony at their local provider’s office that will possibly be attended by local dignitaries and celebrities to help signify the event and give champions a powerful vehicle to share their story. By publicizing champions in local and national press, the foundation can reach the 80 percent of people with hearing loss who have yet to seek assistance and motivate them to take control of their hearing health.
“People need to know about the businesswoman who wears invisible hearing aids so she can discreetly hear her clients better, or the nine Olympic athletes who competed in the 2012 London games while wearing their athletically designed hearing devices, or the 4-year-old who loves to show off her pink hearing aids,” said Ed Keller, president of The HearStrong Foundation. “HearStrong will break down stereotypes and show the humanity of hearing better.”
The foundation will also facilitate hearing device donations to those who need proper hearing devices but cannot afford to buy them on their own.
Roughly 36 million Americans have hearing loss, and that number is on the rise. Recent studies have shown that one in five teenagers has hearing loss, as well as 60 percent of veterans returning from Iraq and Afghanistan. However, due to lack of education and negative connotations, many people choose to suffer in silence. The HearStrong Foundation will change that view once and for all.
Tuesday, June 4, 2013
By Mary Rapaport
The joy of hearing is all about small moments—the sound of bicycle bells on a spring day, an intimate whisper in a crowded restaurant, a granddaughter’s first words. Restoring these moments is what inspires us every day. Every time hearing is restored, another magical moment is created. Hearing is so fundamental that professionals who restore it help their patients start brand new lives.
It is in these moments that audiologists remember why they chose hearing healthcare. It is not surprising that CareerCast recently rated audiology as a top five profession.
ReSound has launched the Moments Movement as a way to recognize hearing healthcare professionals and elevate the patient moments that inspire and motivate them daily. Here are some of the most inspiring moments that have been shared.
Getting to Know Your Wife All Over Again
Adriana Rodriguez-Miciak of Baylor College of Medicine had her "why I chose this career" moment with a young man who has congenital hearing loss. At the fitting, his eyes lit up. He could hear the birds for the first time in probably many, many years. When his wife spoke, he was floored by how natural and clear her voice sounded. It was as if he was getting to know her all over again.
The Cries of Your Newborn Son
Lynda Wayne of Cadence Hearing says her favorite moment was when a young man brought his newborn baby into the office. Prior to hearing aids, he had never heard his child cry or make noises at all. As soon as Dr. Wayne programmed the instruments, his wife brought the baby into the office. The patient's eyes widened and then started to tear up upon hearing his new baby boy. This man, who had a severe hearing loss, had emigrated from Russia and was never fit previously. "This was his first experience with hearing aids, and it certainly was a memorable one," Dr. Wayne said.
Helping a Child with Cancer
Caroline Bjarnason of Integrity Hearing & Balance experienced one of the most profound moments of her career while working as a pediatric audiologist in Southern California. She had been performing routine hearing exams on a child who was undergoing chemotherapy. At one of the exams, she diagnosed a hearing loss. As she explained the results, the patient's mother cried. A few weeks later, the patient came into her office for a hearing aid fitting. During the fitting, the mother realized her child could hear again, and she cried once more. She then turned and said something the audiologist has never forgotten: the mother thanked Ms. Bjarnason for returning her child to her. Of all the things her child had lost to cancer, hearing was the most tragic, she said. "In that moment I realized, more than ever, what an integral part I play in the lives of my patients," Ms. Bjarnason said.
The Sounds of Spring
For Eliza Floyd of Audio Hearing Center, her moment occurred when seeing a patient for a follow-up visit. As the two of them chatted, the patient mentioned that her daughter, who always visits in the spring, had been in town recently. The patient and her daughter were enjoying some conversation one night in the kitchen when, all of a sudden, the patient heard a sound that she recognized but hadn't heard in many years—peepers! "It's a sound that is very unique to spring," Dr. Floyd said. "She was so happy that she could hear them again after so many years and delighted that her daughter could be there to witness the moment."
Emerging from the Silence
Bonny Kuhfal of Bay Area Hearing Services saw an older gentleman from the Philippines who had not heard for many, many years. His daughter told Ms. Kuhfal that he never spoke to anyone and no one ever talked to him; he had withdrawn into total silence. When Ms. Kuhfal turned on the hearing aids, his face lit up with a smile from ear to ear. He said, "I don't want to leave this room. I want to stay and talk to you all day." He was teary eyed, and so was everyone else in the room.
Friday, May 3, 2013
By Thomas Tedeschi, AuD
Vice President, Franchise Development
It usually starts with the small things. You may not notice them, but chances are people around you do. The TV volume is just a few notches louder than usual. The coworker two cubicles down calls your name, and you miss it. Your cell phone shows missed calls even though the ringer's on. The alarm doesn't wake you, but it woke your spouse.
At some point, someone -- a friend, a family member, maybe even a coworker or your boss -- might point out that you may need to get your hearing checked. If you've found yourself in that situation, or maybe you've even started to notice the symptoms yourself, don't fret. You're not alone, and there are solutions available.
Hearing loss is faced by 37 million Americans and reaches across demographic lines, such as age, race, and gender. While the diminishment of a key sense clearly creates physical limitations, hearing loss can also exact an emotional toll. Frustration, depression, anger -- all of these feelings and more are common responses to hearing loss. There’s no simple path in hearing loss, but learning about and recognizing the signs and symptoms opens the door to a wide range of treatment options. Taking the first steps toward proper treatment is one of the smartest, most straightforward things you can do to affect your quality of life.
When we were teens or young adults, there’s a good chance that many of us walked out of a club or concert and found the world to be a little muffled by the time we got home, as if our ears were suddenly packed with a wall of mud. Then we went to bed, woke up in the morning, and went about the next day with hearing back to normal.
The primary, and most obvious, symptom of hearing loss is just that: the loss of clear hearing. In general, this symptom comes across as a muffled feeling, similar to the sensation of trying to listen to TV while wearing earplugs. When hearing loss occurs sharply and suddenly, such as in the concert example above (which would be a temporary threshold shift due to the trauma of the intensity of the sound), it’s easy to distinguish -- you suddenly can’t hear well. For many people dealing with chronic hearing loss, this muffling occurs gradually over months or years, such that the change is often too subtle to notice in day-to-day life.
Next to muffled hearing, tinnitus (a persistent ringing, buzzing, or whining sound in the ears) is one of the most common symptoms of hearing loss. Tinnitus can vary in length, frequency, intensity, and even tone, with some people experiencing a high-pitched tone and others experiencing buzzing, whooshing, clicking, or chirping. Many different factors can cause tinnitus, from loud-level trauma to infection.
Another symptom of hearing loss can be vertigo (dizziness). The vestibular system, which controls balance, is also housed in the inner ear, and diseases such as Meniere’s disease not only affect hearing ability, but also impair the balance system.
In addition, there are a number of diseases and illnesses that can cause hearing loss, including measles, meningitis, and mumps.
Physical symptoms are one thing, but studies have shown that hearing loss can have an emotional impact as well. Perhaps you’ve gradually felt like you’re avoiding friends and family because of their frustration when you can’t understand what they say. Or maybe you’ve begun declining invitations to go to restaurants or public places because you’ve developed a more difficult time keeping track of what’s being said. If you find yourself withdrawing socially, becoming frustrated with the simple act of conversation, or feeling like talking leads to misunderstanding -- in addition to having the physical symptoms, however slight, listed above -- it’s a good idea to get your hearing checked.
In addition to inhibiting social interactions, hearing loss can indirectly create stress in your life by affecting your work, relationships, or finances. If you have hearing loss, communication can become difficult, leading to mixed messages and missed details. Hearing loss can also take a toll on personal relationships, and, in worst-case scenarios, a vicious cycle is created where people on both sides feel misunderstood and frustrated, all while potentially overlooking a medical root cause.
The thought of approaching potentially difficult situations may leave you feeling anxious, frustrated, angry, or depressed. When compounded by the interpersonal strain resulting from miscommunication in various relationships, it becomes clear that hearing loss can create an emotional fallout that ripples negatively through many aspects of your life.
The goal, then, is to recognize the emotional and physical symptoms of hearing loss and move forward with appropriate diagnosis and treatment.
What Comes Next
At Sonus, we always advise patients to take advantage of the many resources available online to research possible conditions underlying their symptoms. Following this advice will help you engage in an informed dialogue with your audiologist and arm you with the appropriate questions to ask to help expedite the most accurate possible diagnosis and facilitate the best rehabilitative strategy.
Millions of people suffer from hearing loss, and a significant number can experience improvement and assistance through modern medicine and technology. With a thorough examination and diagnosis, the nature of your hearing loss symptoms will be clear, as will the options for treatment and moving forward.
Dr. Tedeschi, who has over 30 years of experience in the hearing healthcare field, has been vice president of franchise development at Sonus since September 2009.