Good Vibrations: May 3rd is 1st Bone Anchored Awareness Day!

April 26, 2021 By Leave a Comment

Bone Anchored Awareness Day

May 3rd will be the first ever annual Bone Anchored Awareness Day.

Copenhagen

4/14/2021 12:00:00 AM

Oticon Medical initiates this annually recurring awareness day “Good Vibrations” to celebrate bone anchored hearing as a treatment and to create more awareness about this treatment.Today over 250,000 people – from all over the globe – use some form of bone conductions hearing device. May 3rd, is meant to celebrate them and the treatment – regardless of brand. Providing a day where the users can talk about their bone anchored hearing device.

“At Oticon Medical we recognize the importance of sound, for wellbeing, for development – even for general health. So of course, we are passionate about providing as many people as possible with the best sound imaginable. That also means creating more awareness – not just for product – but for the treatment itself. We hear much too often,” Oticon Medical CEO, Jes Olsen says, “that a person didn’t know that their hearing loss could be alleviated, and therefore have gone years and years unaided. This day, May 3rd,  is our contribution to keeping the conversation of hearing alive” Jes Olsen finishes by wishing all of us a happy and vibrant Good Vibrations day.

At Oticon Medical we recognize the importance of sound, for wellbeing, for development – even for general health

Oticon Medical will be celebrating the date all over the world, with events, information, contests and fun and games. Different activities and events in different countries. It is our hope that other bone anchored brands will join in – making Good Vibrations a true non-brand awareness day. Focussing on the people; on the treatment. The idea is to talk about hearing loss and treatment – not products.

Good Vibrations posts, stories, tweets, reels etc. can be shared by all using the #goodvibrations and the #boneanchoredhearing hashtags and they can be shared on the GoodVibrations Facebook page.

The date, May 3rd is carefully selected as it is the birthday of Per-Ingvar Brånemark. Brånemark was a Swedish physician and research professor and is known as father of osseointegration and the godfather of bone anchored hearing, because his discoveries enabled today’s bone conduction hearing devices.

Therefore, Oticon Medical chose Brånemark’s birthday as annual awareness day for bone anchored hearing. On May 3rd, we want to celebrate the more than 250,000 people all over the world that, today, use bone anchored hearing devices.

Brånemark coined the term osseointegration in the 1960s during studies in bone rheology and defined it as the direct contact between a metal (often titanium) implant and living bone tissue.

Per-Ingvar Brånemark. Brånemark, the father of osseointegration

The first clinical application of titanium implants was in oral surgery, where they continue to be used today. By chance these first dental implants led the way for the first bone conduction hearing implant. In the beginning Brånemark was looking to evaluate the titanium implant’s ability to be fused with the bone. In the process, he used an acoustic method of measurement where he put a bone vibrator on a patient with a dental implant.

One patient, that by chance suffered from hearing loss, heard a sound when the vibrator started. An unexpectedly loud sound, especially for one suffering from hearing loss. A new discovery was born – a bone-anchored implant could be used to send sound efficiently through bone directly to the inner ear.

That was the beginning of a totally new way of treating people who had, up until this point, not been able to hear as they could not benefit from traditional air conduction hearing aids.

Bone anchored hearing systems today consist of a small implant, an abutment/connector and a sound processor that attaches to the abutment/connector. The sound processor transmits sound by conduction through bone directly into the cochlea. In this way, bone anchored hearing systems use both the body’s natural ability to conduct sound as well as its ability to osseointegrate, and thus securing, an implant.

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#goodvibrations  #boneanchoredhearing  #awareness

Def.: Osseointegration (from Latin osseus “bony” and integrare “to make whole”) is the direct structural and functional connection between living bone and the surface of a load-bearing artificial implant

Filed Under: Events, History

Let’s make Ally’s Act, H.R. 477 and S. 41 the law!

April 11, 2021 By Leave a Comment

Ally Tumblin writing her letter to Congressman Joe Neguse, May 2019.

Please help make Ally’s Act the law, H.R. 477 and S. 41

Two years ago, during May 2019, Ally Tumblin, wrote a letter to Congressman Joe Neguse (D-CO) during Better Hearing and Speech Month as part of a community homework assignment, explaining how the hearing device she hears with is often not covered by private insurance companies. She explained that lots of kids and adults just like her need a bone anchored hearing aid to hear. Ally asked Congressman Neguse to help her advocate to hear better. Well, Congressman Neguse received Ally’s letter and he listened to Ally and wrote her back agreeing to stand by her side and help her advocate to hear better. In fact, just months later, Congressman Neguse introduced a piece of legislation that would help Ally and so many others just like her who require the use of bone anchored hearing aids, including children and adults who require the use of cochlear implants as well! Congressman Neguse introduced Ally’s Act, H.R. 5485, named after Ally for her bravery for standing up for the D/HH community and for being such an inspiration. Last year, Ally’s Act was also introduced to the Senate as S. 4532.

On January 27th, 2021 Ally’s Act was reintroduced to the House, known as H.R. 477. Our original co-sponsors, Congressman David McKinley (R-W.VA) and Congressman Mike Thompson (D-CA), both co-chairs for the Congressional Hearing Health Caucus, co-sponsored Ally’s Act again in full support of this piece of legislation. This bill is near and dear to the hearts of many who support Ally’s Act. Congressman Neguse imagined how this would affect him if this were his daughter struggling to hear just like Ally. Congressman McKinley is the only cochlear implant user in all of Congress and his grandson wears a bone anchored hearing aid just like Ally. Ally’s Act was also re-introduced to the Senate during January and is co-led by original co-sponsors Senator Shelley Moore Capito (R- W.VA) and Senator Elizabeth Warren (D-MASS). Our new Senate bill number for Ally’s Act is S. 41. Ally’s Act is also near and dear to Senator Shelley Moore Capito’s heart as she works along side Congressman McKinley and knows of his struggles with his hearing loss and yet how he has managed to become such an influential law maker for the D/HH community thanks to hearing device technology like cochlear implants. Ally’s Act also matters to Senator Elizabeth Warren as she has supported the D/HH community for years by helping with legislation that would help improve audiology services and passing a bill to help with over the counter (OTC) opportunities for better access to traditional hearing aids.

Ally’s Act, H.R. 477 and S. 41 are bipartisan/bicameral national level bills that were re-introduced on January 25th, 2021 ensuring that private insurance companies provide coverage for osseointegrated hearing devices (OIDs), including Bone Anchored Hearing Aids (BAHA) and Cochlear Implants (CI), for children and adults birth to age 64, including services, upgrades, surgery and associated costs that come along with these devices. If Ally’s Act becomes the law, this bill would help hundreds of thousands of children and adults have access to life changing treatment, allowing them to live the lives they dream, participate in the workplace and community and enjoy a high quality of life.

Please help us make Ally’s Act the law! It takes just 2 minutes to click the following link and write to your local Congressmen and Senators, asking them to support Ally’s Act, H.R. 477 and S. 41. https://www.votervoice.net/EveryLife/1/campaigns/80211/respond

Ally’s Act One-Pager Mar2021 lists background on Ally’s Act, H.R. 477 and S. 41, along with our endorsers.

Here is an interview of Ally with Congressman Neguse and Senator Warren talking about why Ally’s Act, H.R. 477 and S. 41 is needed. Please click on the watch on YouTube icon on the bottom left to access this video in full screen.

We are asking everyone to not only write to your local lawmakers, asking them to co-sponsor Ally’s Act, but if you can contact your local lawmaker’s offices and ask them to schedule a Zoom meeting where you can help educate them on Ally’s Act and tell them why this bill is important to you and matters to your family, a friend or your loved one. After using the link above when writing to your local lawmakers, email Rachel or Melissa at Ear Community with your representative’s names and let us know that you would like to reach out asking them to set up a Zoom meeting and we will be on the Zoom meeting with you! Sometimes, letters are not enough and we need to get in front of our lawmakers, helping educate them about the legislation that matters most to us and why it is needed.
Melissa:  EarCommunity@gmail.com
Rachel:   EC.Rachel9@gmail.com

Filed Under: Events, History

Ear Community Welcomes Advisory Board Member, George Scott

March 10, 2021 By Leave a Comment

George Scott

On March, 10th, 2021, the Ear Community Organization welcomed it’s newest Advisory Board Member, George Scott.

George comes to us as an Executive who has worked in Digital and Mobile Technologies related to sports for 20+ years. He became interested in supporting EarCommunity.org after being inspired by Ally’s story on CNN and all that she and her mother Melissa were doing to help adults and children get access to much needed hearing devices through mandated federal insurance coverage.

George experienced hearing loss firsthand when in 2017 he suffered from Sudden Sensorineural Hearing Loss (SSHL) and spent nearly six months struggling to understand conversations, even with the use of hearing aids. He has since recovered thanks to the help of some very dedicated medical professionals and advanced technology in hearing aids. The whole process was very traumatic and gave George a tremendous amount of empathy for the deaf and partially deaf children who are unable to afford the high cost of hearing devices and surgeries that are rarely covered by insurance.

George has joined the Ear Community Board of Advisors with the hope of supporting Melissa, Ally and their organization in bringing hearing coverage to those in need.

“It is my absolute pleasure to welcome George to the Microtia and Aural Atresia community and to our organization,” says Melissa Tumblin. “I have had the privilege of getting to know George since he found our organization a few weeks ago. I have learned of his passion for wanting to help children and adults who have hearing loss, after recently developed sensorineural hearing loss himself. As it turns out, we share many of the same ideals and goals that are near and dear to our hearts. We are excited about George joining our community and our organization and for being inspired by the good our organization is doing. We’re also inspired by George’s journey about his own hearing loss and how he would like to help give back to others in the same situation. Just when you wonder where all of the good people are in our world, George Scott steps up! Thank you and welcome, George!

The Board of Directors and Advisory Board Members
The Ear Community Organization
www.EarCommunity.org
Filed Under: Events, History

Cochlear receives FDA clearance of Baha 6 Max, industry’s smallest 55 dB sound processor now with direct Android streaming

March 8, 2021 By Leave a Comment

– The Baha 6 Max Sound Processor has a fitting range of up to 55 dB SNHL in the same small size as the industry’s current 45 dB devices.

– It is also the first bone conduction sound processor to offer direct streaming from Apple and Android devices, as well as many other new features.

– Processor is indicated for people with SSD (single-sided deafness), conductive or mixed hearing loss.

News provided by

Cochlear Limited

Mar 08, 2021, 09:06 ET

LONE TREE, Colo., March 8, 2021 /PRNewswire/ — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces the U.S. Food and Drug Administration (FDA) clearance of the new Cochlear™ Baha® 6 Max Sound Processor, designed to improve hearing outcomes for people with SSD (single-sided deafness), conductive or mixed hearing loss.

Meet the Baha 6 Max Sound Processor; it is the first of its kind: a premium-power bone conduction sound processor designed for powerful hearing performance. The Baha 6 Max is for individuals with SSD (single-sided deafness), conductive or mixed hearing loss.
Meet the Baha 6 Max Sound Processor; it is the first of its kind: a premium-power bone conduction sound processor designed for powerful hearing performance. The Baha 6 Max is for individuals with SSD (single-sided deafness), conductive or mixed hearing loss.
The new Baha 6 Max Sound Processor provides additional power in the smallest form and is designed to provide the most clear, rich and natural sound possible–reducing the need to choose between hearing performance and size.
The new Baha 6 Max Sound Processor provides additional power in the smallest form and is designed to provide the most clear, rich and natural sound possible–reducing the need to choose between hearing performance and size.
Cochlear receives FDA clearance of the Baha 6 Max Sound Processor, which has a fitting range of up to 55 dB SNHL in the same small size as the industry’s current 45 dB devices. It is also the first bone conduction sound processor to offer direct streaming from Apple and Android devices.
Cochlear receives FDA clearance of the Baha 6 Max Sound Processor, which has a fitting range of up to 55 dB SNHL in the same small size as the industry’s current 45 dB devices. It is also the first bone conduction sound processor to offer direct streaming from Apple and Android devices

With a fitting range of up to 55 dB SNHL (sensorineural hearing level) in the same small size as current 45 dB devices1, the Baha 6 Max is the first of its kind: a premium-power bone conduction sound processor designed for powerful hearing performance. The Baha 6 Max is also the first bone conduction sound processor to offer direct streaming from Apple® and Android™ devices.2 Direct streaming from Apple devices has been available in the Baha 5 Sound Processor since 2015. The new processor provides additional power in the smallest form1,3 and is designed to provide the most clear, rich and natural sound possible–reducing the need to choose between hearing performance and size.

Learn more about the Baha 6 Max Sound Processor: www.Cochlear.us/Baha6Max.  

Additional improvements of the Baha 6 Max over the previous generation Baha 5 Sound Processor include:

  • New noise and feedback reduction features
  • Frequency range up to 9.7 kHz
  • Streamlined profile by up to 2 mm1
  • IP68-rating dust and water protection*
  • 50 percent longer battery life4
  • Baha Smart App compatibility with Apple Watch®5
  • Child-friendly features, including LED indicator
  • New mint color option for sound processor front

“We at Cochlear continue to be inspired by all our recipients who get to experience fulfilling, active lives full of connection, and we innovate new products to help enable their success,” said Tony Manna, President, Cochlear Americas. “As such with the Baha 6 Max, we have delivered a leap forward in bone conduction hearing technology, providing more power in the industry’s smallest bone conduction sound processor with greater connectivity and hearing features. Our goal with this new device is to continue bringing a hearing experience full of clear, rich and natural sound, while introducing new elements that aim to make great hearing an even more seamless part of everyday life.”

Further feature highlights

  • Improved hearing in noise: Cochlear has more than 40 years of experience in bone conduction hearing solutions, and its market research shows most recipients want to improve their ability to hear in noisy environments.6

Research suggests extended bandwidth can improve recognition of high-frequency consonants in quiet and in noise7, so the new, high-powered Xidium™ platform in the Baha 6 Max features a frequency range of up to 9.7 kHz. In a study, participants using the Baha 6 Max showed a significant improvement in understanding speech in both quiet and noisy environments compared to the Baha 5 Sound Processor.8

Cochlear’s SmartSound™ iQ signal processing suite boasts new impulse noise reduction and improved feedback management. Along with other features such as the scene classifier and active gain adjustment, this advanced signal processing technology aims to deliver a clear signal, helping the user fully take in their surroundings. The Baha 6 Max showed a significant difference in terms of sound clarity (more than 35 percent improvement) and sound quality (more than 25 percent improvement) when compared with the Baha 5 Sound Processor.8

  • More power: Usage data from market research suggests many users of bone conduction devices may be underfit, and therefore may benefit from additional dynamic hearing range6, which provides capacity should a person’s hearing loss worsen over time. The new BC Drive™ II transducer, which powers the Baha 6 Max, is twice as efficient than the BC Drive on the Baha 5 Sound Processor, delivering 7 dB more average maximum power.9

  • Greater connectivity: In addition to being the first bone conduction sound processor with direct audio streaming from Android and Apple devices, the Baha 6 Max is compatible with the Baha Smart App and allows users to connect to an Apple Watch, so they can discreetly fine-tune their sound processor settings. The Smart App also offers additional options to personalize hearing, including the expanded three-band equalizer and settings to customize noise reduction.

  • System readiness: The Baha 6 Max Sound Processor introduces system readiness for our expanding connected care portfolio.

  • Designed with children in mind**: An LED indicator allows parents, clinicians and carers to be sure the processor is turned on and connected. The small size of the Baha 6 Max makes it a discreet solution for children and adults, and the new LowPro™ snap coupling even brings the device 2 mm closer to the head1, so it sits closer to the head than other bone conduction devices. The Baha 6 Max is also designed to keep up with active children, with its IP68 dust- and water-protection rating. For clinicians, the new Baha Fitting Software 6.0 introduces new workflows to guide fittings, as well as options to customize settings to the child’s specific needs.

“The Baha 6 Max was designed as a direct response to the needs of patients who are looking for improved hearing performance in their hearing device but want the smallest device possible,” said Anna Anderström, Group Lead Bone Conduction Solutions, Cochlear Americas. “With an all-new transducer, we were able to increase the power output while keeping the size down. This is also a benefit to our pediatric population where early access to hearing is so important for language development.”

The Baha 6 Max Sound Processor, Baha Fitting Software 6.0 and Baha Smart App are already approved in Canada. The Baha 6 Max Sound Processor will be commercially available across the United States and Canada in the first half of 2021.

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear. www.cochlear.com/us

References

  1. Land J. Comparison tech data Baha 6 Max, legacy and competition. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1762475.
  2. The Cochlear Baha 6 Max Sound Processor is compatible with Apple and Android devices. For compatibility information, visit www.cochlear.com/compatibility.
  3. Hoffman J. Subjective evaluation of clear rich and natural sound. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1788013.
  4. In an average use case at similar prescriptions. Davidsson B. Technical Report: Battery autonomy in Baha 6 Max vs Baha 5. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1770958.
  5. The Cochlear Baha Smart App is available on App Store and Google Play.
  6. Leung B. Technical Report: Baha 6 Max data analysis and correlation report. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1772435.
  7. Van Eeckhoutte M, Folkeard P, Glista D, Scollie S. Speech recognition, loudness, and preference with extended bandwidth hearing aids for adult hearing aid users. Int J Audiol. 2020;1-12.
  8. Hua H. Baha 6 Max Home test CIR CBAS5779. Cochlear Bone Anchored Solutions AB, Sweden. 2021; D1801512.
  9. Bergs T. Technical Report: Performance comparison A1 vs A2 actuators. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1770991.

* The Cochlear Baha 6 Max Sound Processor, with battery compartment excluded, is dust and water resistant to level IP68 of the International Standard IEC60529. Refer to the relevant user guide for more information. Tested by the RISE Research Institutes of Sweden AB.

** In the United States and Canada, the Baha Implant System is contraindicated in children below the age of 5.

Android, Google Play and the Google Play logo are trademarks of Google LLC.

Apple, the Apple logo, Apple Watch, iPhone, iPad and iPod are trademarks of Apple Inc., registered in the U.S. and other countries.

Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

© Cochlear Limited 2021. All rights reserved.

SOURCE Cochlear Limited

Related Links

http://www.Cochlear.com/US

Filed Under: Events, History

Inspired by Broomfield girl, U.S. Rep. Joe Neguse reintroduces ‘Ally’s Act’

February 8, 2021 By Leave a Comment

By | bdance@prairiemountainmedia.com |
PUBLISHED: | UPDATED:

BROOMFIELD, CO – February 5, 2021: Melissa Tumblin and daughter Ally, hold the letters to and from Joe Neguse. Colorado Rep. Joe Neguse reintroduced legislation in January titled Ally’s Act, a bill inspired by Ally Tumblin , an 11-year-old Broomfield resident to increase access to specialized hearing devices.

Ally wrote a letter to Neguse in 2019 asking for his support for those with hearing impairments. Melissa Tumblin, Ally’s mother, started a foundation advocating for insurance to cover the cost of hearing devices. (Cliff Grassmick/Staff Photographer)

Melissa Tumblin has spent the past 10 years advocating for the hearing community after her daughter, Ally, was born without a right ear.

But as hard as Melissa had been working, one letter marked a turning point: a letter written by Ally to U.S. Rep Joe Neguse.

For a school assignment, Ally wrote a letter to a lawmaker about something she cared about. As Ally brainstormed for the assignment, she exclaimed, “Mom, my BAHA!” Melissa recalled.

Ally was referring to her bone anchored hearing aid, often called a BAHA. She wrote a letter to Neguse dated May 1, 2019.

“I am deaf in my right ear. I wear a hearing device called a bone conduction hearing aid that helps me hear better, but it is not covered under insurance,” the handwritten letter reads. “There are thousands of children and adults just like me who need this hearing device to hear better. Please help me advocate for hearing better by mandating hearing device coverage in Colorado for a bone conduction hearing aid.

”To Melissa’s surprise, Neguse wrote back, promising to advocate alongside Ally. In December 2019, Neguse introduced legislation that would ensure private insurance companies provide coverage for osseointegrated hearing devices, or OIDs, including bone anchored hearing aids and cochlear implants.

“You can try a million times and no one listens,” Melissa said. “He did. He listened.”

BROOMFIELD, CO – February 5, 2021: Ally Tumblin holds the letter she wrote to Joe Neguse and the return letter from Neguse. Colorado Rep. Joe Neguse reintroduced legislation in January titled Ally’s Act, a bill inspired by Ally Tumblin , an 11-year-old Broomfield resident to increase access to specialized hearing devices. Ally wrote a letter to Neguse in 2019 asking for his support for those with hearing impairments.

In January, Neguse reintroduced the legislation titled “Ally’s Act” in the 117th Congress. It was the first bill he introduced this Congress.

“For Ally and so many others, specialized hearing devices are critical for communicating. For insurance companies to deny coverage for these essential devices goes against common-sense,” Neguse said in a news release. “Cochlear implants and bone anchored hearing aids have helped countless individuals to communicate, and to thrive in their communities at school, work and in their social lives.”

With Ally’s rare hearing loss, it seemed Melissa had more questions than doctors had answers after Ally was born. When Ally was 10 months old, Melissa asked whether there was a hearing device Ally could benefit from.

“They told me she’s not a candidate for a cochlear implant,” Melissa recalled. “I later realized that’s not even the one she needed. I did my own research and found out she needed the BAHA.”

Melissa learned some kids were getting BAHAs as early as 2 months old. At this point, Ally was 11 months old.

“I was frustrated. I was sad. I was mad … All of this I learned in a crash course over the course of days, and I started a Facebook support group,” Melissa said. “Families from all over the globe joined within the year and had the same questions.”

Melissa created a website for her support group, which evolved into the nonprofit she titled Ear Community.

Melissa soon realized she was not alone. Ear Community helps children and adults born with microtia, when an ear is missing or undeveloped, and aural atresia, when the ear canal is missing resulting in hearing loss. Since starting Ear Community, Melissa said she’s helped thousands of people around the world.

Now that Ally’s Act has been reintroduced, Melissa said she’s asking the public to contact their congressman or congresswoman and senators and ask for their support.

“We need a little less than 300 co-sponsors for this bill,” she said. “The more letters they get, (the bill) typically gets more support. When the bill goes before committees, they’re already well informed about it.”

The bill has bicameral support from Sens. Shelley Capito and Elizabeth Warren. Ally and Melissa joined Zoom call with Warren and Neguse to discuss the bill last week.

“I can’t always hear good without my BAHA, and other kids like me have trouble hearing, too,” Ally told Warren. “I wanted to ask for help because not everyone who needs a BAHA can get one to hear better.”

Warren thanked Ally for her letter and said she was glad to introduce the bipartisan legislation to increase hearing device access.

“Despite the critical and life-changing support these specialized hearing devices provide, many adults and children throughout the United States cannot obtain them because they are too expensive,” Warren said in the news release.

The devices range from $5,000 to $12,000 each, and have to be replaced every five years.

Though Ally is making history for the hearing impaired community, Melissa said Ally hasn’t fully grasped the gravity of what she’s done.

“She’s very excited, but at the same time she has no idea the good she’s done. She has no idea the change and the difference she’s making,” Melissa said. “She’s just a little girl who wrote a letter trying to get help … No other person could’ve done it but Ally.”

Ally on Friday said it felt good to know she’s helping her deaf and hard of hearing friends.

Neguse thanked Ally for writing to him in the news release.

“I’m incredibly grateful for Ally’s initiative and courage to bring this issue to my office so we could get to work on a legislative fix to address it,” Neguse said.

Ally and Melissa also shared their story with “Good Morning America,” which will appear on the program’s website either Tuesday or Wednesday next week, Melissa said.

For more information on Ear Community, visit earcommunity.org. To watch Ally talk with Neguse and Warren, visit https://bit.ly/2N3HadK.

Filed Under: Events, History

Globally unique MRI Guarantee: the highest MRI safety with hearing implants from MED-EL

February 8, 2021 By Leave a Comment
Feb 2, 2021

Worry-free, safe magnetic resonance imaging (MRI) with MED-EL cochlear, middle ear or bone conduction implants – now with lifetime guarantee! For immediate access to an MRI examination without surgery, discomfort or hearing downtime.

February 02, 2021– (Innsbruck, Austria) – The innovative design of the implant magnets from MED-EL is completely safe during an MRI examination. As of now, the global innovation leader in hearing solutions is emphasising this safety with an MRI guarantee that is as yet unmatched. With this, MED-EL is the only manufacturer to accept liability for damage to all cochlear implants that have been produced since 1994, all bone conduction implants and the current generation of middle ear implants during an MRI examination. Users of these MED-EL implants can therefore not only undergo an MRI examination at any time without the need for surgical removal of the magnets* and without pain – they can also do so safely and with no worries.

Three in four people will require an MRI scan in the next ten years.** Whether routine or in an emergency: patients with severe hearing loss may face a challenge if the magnets in their hearing implants are not safe inside the MRI machine. This requires the prior surgical removal of the magnets. Hearing ability is temporarily lost and long-term damage to the implant may occur. If the patient declines surgery, they may suffer from severe pain during the examination coupled with the possible dislocation of the magnet.

The highest MRI safety with MED-EL

Not all implants carry this risk. As a leading manufacturer of implantable hearing solutions, MED-EL has for more than twenty years made a point of only producing implants that offer outstanding MRI safety. To emphasise this requirement, MED-EL offers the unique MRI Guarantee which means no damage to the device during an MRI examination. MED-EL is thereby the only manufacturer to issue its users with a comprehensive global lifetime MRI guarantee.

“The MRI Guarantee ensures more safety, comfort and peace of mind during MRI examinations,” says Alexander Hofer, Corporate Director of Product Management at MED-EL. “We take care of our users for a lifetime and they should have the opportunity to make use of everything modern medicine has to offer. This is especially important when diagnosing serious illnesses such as cancer, tumours, multiple sclerosis or Parkinson’s disease,” stresses Alexander Hofer.

Being able to undergo magnetic resonance imaging immediately can also be crucial in emergencies such as an accident. A further benefit: people with severe hearing loss only have to go without their ability to hear during the MRI examination itself.

Innovative technology excludes complications

The safe and reliable technology from MED-EL ensures that the magnets in place during the magnetic resonance imaging are neither damaged, nor dislocate causing pain. Only the external components, such as the audio processor, must be removed prior to the MRI examination.

“MED-EL has developed its own highly innovative, patented cochlear implant system with state-of-the-art implant magnets and their fixation within the implant. This excludes, for example, a dislocation of the magnet during an MRI scan, which can be very painful for the patient,” says Martin Zimmerling, Head of Implant Development at MED-EL. “With the SYNCHRONY cochlear implants, the magnet can freely rotate and align according to the magnetic field of the MRI scan. With the altered implant design, undesirable forces during the MRI scan and the associated pain for the patient are reliably prevented,” explains Martin Zimmerling. “We are proud not only that the latest generation of our cochlear implants is compatible with MRI machines, but that all cochlear implants produced since 1994 are too, as well as all bone conduction implants and the latest middle ear implant from MED-EL.”

The increasing significance of magnetic resonance imaging makes it clear how important it is to provide people with severe hearing loss access to this gentle and high-resolution imaging process. MED-EL rises to this responsibility and provides extra security and comfort for all users with the MRI Guarantee.

*So as to avoid imaging difficulties in the immediate vicinity of the implant, it may be advisable to remove the magnets.

**Source: OECD. Magnetic resonance imaging exams 2016–2019.

About MED-EL

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 groundbreaking research led to the development of the world’s first micro-electronic 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 2,200 employees from around 75 nations and has 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 124 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, auditory brainstem implants as well as surgical and non-surgical bone conduction devices. www.medel.com

CEO
Doz. DI Dr DDr med. h.c. Ingeborg Hochmair

Press contact
Thomas Herrmann
MED-EL Medical Electronics
Fürstenweg 77a
6020 Innsbruck
Austria

T: +43 5 7788-0

www.medel.com

Rebecca Novak Tibbitt, MPH
RNT Communications, LLC :
T:  (704) 341-1544
Rebecca@RNTCommunications.com

Filed Under: Events, History

Maryland boy receives access to sound thanks to Oticon Medical and Ear Community

February 1, 2021 By Leave a Comment

Allan De Leon of Maryland, 2 years old born with Microtia and Atresia and CFM, received a donated Ponto 4 from Oticon Medical

Meet Allan De Leon who is 2 years old and was born with Microtia and Atresia of his right ear, including Craniofacial Microsomia. Allan and his family live in Maryland after recently relocating from Guatemala. Allan’s family was unable to provide a permanent bone conduction hearing device of any kind for him due to financial restrictions, and no access to insurance coverage. Because Jovina and Alan (Allan’s parents) are from Guatemala, their first spoken language is Spanish. Shortly after Allan was born, not only were they learning to acclimate to a new country with a new language, they also had to learn to navigate how to help their son get the medical help he needed in addition to addressing his hearing loss.

Luckily, Allan was able to become a patient at John’s Hopkins where he has been able to receive the help he needs from an entire medical team. One of Allan’s doctors is Allison McGrath, AuD. who knew about helpful resources like Ear Community and was hopeful that our organization was able to help Allan obtain a hearing device to help him hear. Dr. McGrath helped the family apply to Ear Community for an Oticon Medical Ponto 4 that would give him access to sound so he could not only hear his best while his speech and language skills were coming in, but to be given the opportunity to be bilingual at such an early age. His hearing is key as he grows and develops and starts attending school, making friends, and doing all of the other fun things that kids do!

Dr. McGrath made it a special point to tell us how hard Allan’s parents have worked hard to get him everything he needs. She said, “I will say Allan’s family is extremely motivated to provide Allan with whatever he needs to succeed. They make every appointment despite challenges such as language barriers, limitations related to COVID, etc. Allan was borrowing an older loaner device, and his family and team worked with him to get him to wear that, so I have no doubts that his new, updated Oticon Medical Ponto 4 will be a great change and make a world of a difference for Allan and his development.”

When Ear Community’s Board of Directors received the family’s application and were informed of Allan’s challenges, the board knew how important it was that they help him have better access to hearing. On January 26th, 2021, Allan received a new Oticon Medical Ponto 4 on a soft headband through Ear Community. Allan’s parents were grateful to find out that our Ear Community Organization could help him hear better with a new Oticon Medical Ponto 4 – talk about a great way to start the new year! Thank you to Dr. McGrath at John’s Hopkins for helping advocate for Allan’s family with his hearing loss and for helping the family discover the Ear Community Organization. A special thank you to Dr. McGrath for donating her time and services to program and fit Allan with his new Oticon Medical Ponto 4.

A very special thank you to Alan Raffauf, Vice President of Marketing and Operations of Oticon Medical US, and to Beverly Ostrowski, Director of Customer Service for Oticon Medical US, for donating a Ponto 4 to the Ear Community Organization so Allan could receive the gift of hearing and thrive. Oticon Medical is a well-respected international hearing device manufacturer that is a part of the “William Demant Group [which has] 100-plus years of experience in audiology and sound processing and established manufacturing and logistics infrastructure. Ear Community would also like to thank our donors and members of the community who want to help our organization continue our work – none of this would be possible without your support! We are so happy to have been a part of helping Allan hear better!

“It is always a miracle to see the smile on a family’s face when they realize their child is now hearing their best thanks to being given the opportunity to be aided with a bone conduction hearing device” says Melissa Tumblin, Ear Community Founder. “Ear Community strives to help the individuals and their families within the Microtia and Atresia community in many ways, providing information and help so their loved ones can thrive and live the happiest lives,” says Melissa Tumblin. “We look forward to watching Allan grow and thrive each day!”

Thank you,
The Ear Community Organization
www.EarCommunity.org

Filed Under: Events, History

Capito, Warren Re-Introduce Ally’s Act

January 28, 2021 By Leave a Comment

WASHINGTON, D.C. – U.S. Senators Shelley Moore Capito (R-W.Va.) and Elizabeth Warren (D-Mass.) re-introduced Ally’s Act, bipartisan legislation that would ensure private insurance companies provide coverage for osseointegrated hearing devices (OIDs), including bone anchored hearing aids (BAHAs) and cochlear implants. OIDs are a type of hearing aid that benefit a wide range of hearing loss victims and are often the only hearing device that can restore hearing for individuals born with hearing loss. Senators Capito and Warren originally introduced Ally’s Act last September.

“For people who suffer from hearing loss, devices and implants like OIDs and BAHAs are life-changing. Our senses are something we so often take for granted, and ensuring that insurance companies cover these hearing aids provides major relief and comfort to those born with hearing loss and their families. I’m proud to team up with Senator Warren to re-introduce Ally’s Act, and I look forward to continuing to work to establish better access to these critical hearing devices,” said Senator Capito.

“Despite the critical and life-changing support these specialized hearing devices provide, many adults and children throughout the United States cannot obtain them because they are too expensive. This is why I’m glad to reintroduce this bipartisan legislation, which would increase device access and ensure that no individual with hearing loss is left behind,” said Senator Warren.

A companion bill was introduced in the U.S. House of Representatives by Congressmen Joe Neguse (D-Colo.), David B. McKinley, P.E. (R-W.Va.), and Mike Thompson (D-Calif.).

BACKGROUND:

The legislation is named after eleven-year old Colorado-native, Ally Tumblin, who was born without a right ear or hearing canal and therefore requires the use of a BAHA. Following a denial for her hearing device, Ally and her mother formed the organization, “Ear Community” to help advocate for insurance coverage of these hearing devices to ensure no person is left unable to hear because of private insurance companies’ refusal to cover OIDs.

A one-pager on the legislation can be found here.

Bill text can be found here.

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Filed Under: Events, History

Congressman Joe Neguse Reintroduces “Ally’s Act” His Bipartisan Bill Inspired By 11-Year-Old Broomfield Constituent, to Increase Access to Specialized Hearing

January 28, 2021 By Leave a Comment

January 27, 2021 Washington, D.C.—Today, Congressman Joe Neguse, announced the reintroduction of “Ally’s Act,” his bicameral, bipartisan legislation to require private insurance companies to cover osseointegrated hearing devices (“OIDs”), including bone anchored hearing aids (“BAHA”) and cochlear implants. The bill was inspired by Ally, an 11-year-old from Broomfield, Colorado, who was born without a right ear or hearing canal and therefore requires the use of a BAHA. After Ally’s insurance company denied coverage of her hearing device, her mother Melissa formed the organization Ear Community to help advocate for insurance coverage of these devices to ensure no person is left unable to hear because of private insurance companies’ refusal to provide coverage.

When Ally wrote a letter to Congressman Joe Neguse explaining her situation, he got right to work introducing a bill to fix the issue, naming it “Ally’s Act” in her honor.

“For Ally and so many others, specialized hearing devices are critical for communicating. For insurance companies to deny coverage for these essential devices goes against common-sense. Cochlear implants and bone anchored hearing aids have helped countless individuals to communicate, and to thrive in their communities at school, work and in their social lives,” said Congressman Neguse. “I’m incredibly grateful for Ally’s initiative and courage to bring this issue to my office so we could get to work on a legislative fix to address it.”

“In my own experience with Ally, and through my work with Ear Community, I encounter the struggle to convince private insurance that these devices are necessary nearly every day,” said Melissa Tumblin, Executive Director and Founder of Ear Community. “Hearing device insurance coverage needs to be consistent across the U.S. and I look forward to continuing to work with Rep. Neguse to ensure that it becomes so.”

Ally’s Act is co-led by Congressmen David B. McKinley, P.E. (R-WV) and Congressman Mike Thompson (D-CA), the co-chairs of the Congressional Hearing Health Caucus, and holds bicameral support from Senator Elizabeth Warren and Senator Shelley Capito in the Senate.

“As the only Member of Congress with a cochlear implant, I know from firsthand experience the difference in the quality of life these devices can provide,” said Congressman David McKinley. “Ally’s Act will help thousands of Americans with severe hearing loss gain access to life-changing treatment.”

“Ensuring that everyone can access the health care technology they need to fully hear and communicate is critical to our work to expand access to health care, said Congressman Mike Thompson. “That’s why I am proud to be an original coauthor of this bill to require insurers to cover hearing devices for children and adults with congenital hearing defects. These devices are crucial to helping people be full participants in their daily lives and I’m glad we have a solution to help ensure folks can afford them.”

“Despite the critical and life-changing support these specialized hearing devices provide, many adults and children throughout the United States cannot obtain them because they are too expensive,” said Senator Elizabeth Warren. “This is why I’m glad to introduce this bipartisan legislation, which would increase device access and ensure that no individual with hearing loss is left behind.”

“For people who suffer from hearing loss, devices and implants like OIDs and BAHAs are life-changing. Our senses are something we so often take for granted, and ensuring that insurance companies cover these hearing aids provides major relief and comfort to those born with hearing loss and their families. I’m proud to team up with Senator Warren to re-introduce Ally’s Act, and I look forward to continuing to work to establish better access to these critical hearing devices,” said Senator Shelley Moore Capito.

Many throughout the United States are born with hearing loss due to congenital anomalies, including aural atresia (underdeveloped or absent ear canals) and/or microtia (physically missing outer ears). OIDs, including BAHA’s and Cochlear implants, help different forms of hearing loss than traditional hearing aids and are often the only hearing device that can restore hearing for these individuals.

“American Cochlear Implant Alliance enthusiastically supports Ally’s Act, legislation intended to ensure that Americans have access to hearing implants including cochlear and osseointegrated implants,” said Donna L. Sorkin, Executive Director, American Cochlear Implant Alliance. “Representative Neguse has demonstrated leadership and understanding of the extraordinary value of appropriate hearing healthcare for people of all ages, allowing those who need them to hear to pursue education, participate in the workplace, and enjoy a high quality of life.”

“The American Speech-Language-Hearing Association applauds Representative Neguse for reintroducing Ally’s Act, along with Representatives McKinley and Thompson, co-chairs of the Congressional Hearing Health Caucus,” said A. Lynn Williams, PhD, CCC-SLP, and ASHA 2021 President. “Being able to effectively communicate is a basic human right, and this proposal will help ensure that individuals born with congenital hearing loss—and those who require implantable hearing devices—have access to needed care and hearing technology by ensuring appropriate coverage by private insurers.”

This legislation is supported by the following organizations and individuals dedicated to ensuring private insurance coverage of these specialized hearing devices: This bill is endorsed by Ear Community; the American Cochlear Implant Alliance; the American Academy of Audiology; the American Speech-Language-Hearing Association; Waiting to Hear; HearStrong; Lemon Aids 4 Hearing; Songs for Sound, Inc; American Tinnitus Association; the Alexander Graham Bell Association for the Deaf and Hard of Hearing; City and County of Broomfield, Colorado; Hands & Voices; Harvard Medical School – Massachusetts Eye and Ear/Otolaryngology; Let Them Hear Foundation; Morgan’s Magical Ears; Educational Audiology Association; Dallas Ear Institute; the Acoustic Neuroma Association; Hearing Health Foundation; Colorado Academy of Audiology; the California Ear Institute; Aid the Silent; HearAid Foundation; New York Eye and Ear Infirmary of Mount Sinai; Microtia and Atresia at Stanford Hospital and Clinics/Otolaryngology; the American Pediatric Surgical Association; American Society of Pediatric Otolaryngology; Michigan Medicine – Department of Otolaryngology; University of Pittsburgh Medical Center/Otolaryngology; the Otolaryngology Department at Columbia University Irving Medical Center; Chad Ruffin, MD; Proliance Surgeons; Prader-Willi Syndrome Association/USA Advocacy Committee; Weill Cornell Medical College – Departments of Otolaryngology and Audiology; Hearing Industries Association; Hearing Loss Association of America; Plastic Surgery Department at Johns Hopkins; Association of Medical Professionals with Hearing Losses; the University of Southern California Caruso Department of Otolaryngology – Head & Neck Surgery; University of California San Francisco Medical School/Department of Otolaryngology and Cochlear Implant Center; and Johns Hopkins Biomedical Engineering and Auditory Research Department.

Click here for link to press release.

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Filed Under: Events, History

MED-EL USA Launches SAMBA 2 Audio Processor for the BONEBRIDGE Bone Conduction System

January 12, 2021 By Leave a Comment

                    SAMBA 2

Intelligent Sound Adapter 2.0 automatically detects, optimizes settings to match environment

January 6, 2021 – (DURHAM, NC) – MED-EL USA, a leader in implantable hearing solutions, today announced the launch of the SAMBA 2, a next-generation audio processor for the BONEBRIDGE Bone Conduction System, which includes the recently launched BCI 602. BCI 602 is an active transcutaneous bone conduction implant that leaves skin intact. The BONEBRIDGE System is indicated for individuals age 12 years and older with conductive hearing loss, mixed hearing loss, or single-sided deafness.

The U.S. Food and Drug Administration (FDA)-cleared SAMBA 2 Audio Processor features enhancements for ease of listening and handling. Intelligent Sound Adapter 2.0 automatically adjusts settings to match different environments that are particularly challenging to people with hearing loss. This includes an automatic setting for listening in cars which uses Speech Tracking to identify the optimal microphone mode for the user to understand conversation coming from the side or behind.

SAMBA 2 is also designed for easier listening in complex environments such as restaurants, effectively reducing the impact of noise, for example interfering background conversations and the clattering of plates and silverware, while adaptive directional microphones and directional speech enhancement allow the user to focus on their conversation.

“SAMBA 2 is a great example of the ongoing collaboration that MED-EL has with our recipients, even after they receive a hearing implant,” said Raymond Gamble, President & CEO, MED-EL North America. “We listened closely to feedback and worked diligently with our engineers to make the listening experience even more effortless for our BONEBRIDGE recipients.”

SAMBA 2 provides the longest lasting battery life of any active transcutaneous audio processor on the market, with approximately 8 to 10 days from one standard 675 hearing aid battery. When the time comes, battery changes are fast and easy thanks to SAMBA 2’s intuitive design.

SAMBA 2 GO connects wirelessly to Bluetooth devices and via a cable to non-Bluetooth devices to allow streaming from mobile phones, televisions and electronic devices. It can also be used with FM systems and remote microphones for better hearing in noisy environments. And, while the Intelligent Sound Adapter 2.0 adjusts settings automatically, recipients still have control over their settings with the SAMBA 2 Remote, an app available for iPhone and Android that enables users to switch between settings without a separate remote control. The Intelligent Sound Adapter 2.0 then “learns” which settings the user most often changes manually and adapts.

Thin and lightweight, SAMBA 2 offers recipients a wide array of easily interchangeable covers so the audio processor may be worn discreetly under the hair, or worn to stand out with colorful designs. The audio processor is dust, sweat and splashproof, and can be completely submersed in water with the optional WaterWear waterproof cover.

Consistent with MED-EL’s industry-leading legacy support, SAMBA 2 is compatible with both versions of the BONEBRIDGE Bone Conduction Implant, the BCI 601 and BCI 602. BONEBRIDGE bone conduction implants are also engineered to be compatible with future generations of audio processors, allowing recipients to access the latest hearing technology, no matter when they received their implant.

For more information about SAMBA 2, BONEBRIDGE candidates and recipients can visit: https://www.medel.com/en-us/hearing-solutions/samba2.

About the BONEBRIDGE Bone Conduction System

In 2018, after successful use internationally, MED-EL USA launched the country’s first active transcutaneous bone conduction system, BONEBRIDGE, marking the beginning of a new era in bone conduction stimulation. The groundbreaking BONEBRIDGE Bone Conduction System was comprised of an internal implant, BCI 601, and the externally worn SAMBA Audio Processor. Just a year later, MED-EL announced the FDA clearance of the BCI 602, featuring design optimizations to support a streamlined surgery. The second-generation implant for the BONEBRIDGE System was developed through a long and valued partnership with ENT surgeons, hearing health professionals and the hearing loss community. Through these relationships, MED-EL has a proven history of continuous advancement in active transcutaneous bone conduction implant technology.

About MED-EL

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 micro-electronic 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 2,200 employees from around 75 nations and has 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 124 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s global portfolio of hearing solutions includes cochlear implant systems, a combined Electric Acoustic Stimulation hearing implant system, and bone conduction devices. www.medel.co

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MEDIA CONTACT:

Rebecca Novak Tibbitt
T: 704-341-1544
E: media.us@medel.com

Filed Under: Events, History
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