Ear Community Welcomes Advisory Board Member, George Scott

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

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

– 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.

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

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

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.

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

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

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

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

Capito, Warren Re-Introduce Ally’s Act

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.

# # #

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

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

                    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

A Christmas gift of hearing for one little boy thanks to Cochlear Americas and Ear Community

Katie and JJ Shear at his Baha 5 fitting on 12/22/2020, West Virginia.

Katie and JJ Shear at his Baha 5 fitting on 12/22/2020, Charleston, West Virginia.

Christmas miracles do happen, even during a pandemic in 2020! Here is a heartwarming story about the love and advocacy of one West Virginia family for their son. Meet the Shear family! Katie and Andrew Shear’s son, JJ, was born this summer – a shining moment during this extraordinarily challenging year. Prior to JJ being born, Andrew and Katie had never heard of Microtia or Atresia and knew little about the world of hearing loss. When JJ was born, Katie was shocked when she heard someone in the operating room utter, “he’s missing an ear.” The Shear Family learned that JJ was born with Microtia and Aural Atresia of his left ear.

Katie and Andrew wasted no time when researching all the options that would help JJ. Once learning more about his hearing loss from his ENT and audiologist, they quickly understood how important it was for JJ to hear better. Especially, during the critical years of development (birth to age 3) when speech and language skills are developing.

After learning about a hearing device that would help their son hear better, they quickly applied for a bone conduction hearing aid (BAHA) through their insurance provider. Katie believed that “by paying into a health insurance provider, assuming that by paying health insurance premiums on a monthly basis would ensure that medical tests, medical devices, and routine care around his ear would be covered. After all, isn’t this why you pay the health insurance premiums, for situations like this?” To the Shear Family’s surprise, they quickly learned that this was not the case. JJ’s family was denied their claim for a bone anchored hearing device for their son by United Health Care. The response from their insurance provider was that a hearing device was “not medically necessary” and “to seek alternative options” even though JJ’s ENT and audiologist both recommended the use of a bone conduction hearing device to help JJ hear. While the family had already researched all options for JJ’s hearing, they already knew that there was no alternative option to help him hear better at this time other than with a hearing device. The family then filed an appeal with their insurance provider, but sadly their appeal was also denied.

The Shear Family was still hopeful to get JJ a hearing device though. A couple of months later, Andrew decided it was time to make a job transition. Under his family’s new insurance plan and provider, they applied for a BAHA for JJ. Again, to the family’s surprise, the new insurance provider (Meritain Health) also denied their claim for a hearing device for JJ. This time the insurance provider stated that “A BAHA is classified as a hearing aid and we don’t cover hearing aids.” This is when the Shear Family knew they had to look at other options to help JJ hear.

Parents will do anything to give their children a healthy and normal life, but for one Charleston family it has been an uphill battle. (Courtesy of Kara Blakeman Photography via the Shear Family)

Luckily, Katie and Andrew discovered the Ear Community Organization early on when researching Microtia and Atresia. While researching information for JJ, the family also noticed that Ear Community was championing a piece of legislation called Ally’s Act (H.R. 5485 and S. 4532), a bill that would help ensure that private insurers cover the very hearing device that JJ had been denied twice by two different insurance providers the family had coverage with. Katie reached out to Melissa Tumblin, Founder of Ear Community, and immediately found a friend and advocate. The Shear family’s situation is exactly why Ear Community is championing Ally’s Act. Katie and Andrew then applied for a BAHA through Ear Community for JJ. As a way of helping give back, Katie and Andrew have begun advocating for Ally’s Act and are hopeful that this bill will become the law someday. The Shear Family does not want another child to be denied the opportunity to hear like their son JJ was. Katie and Andrew shear’s story was also featured on their local news in a news clip that can be found here.

Ear Community’s board of directors were touched by JJ’s story and yet so disappointed to see the uphill battle the Shear family had faced with their insurers in trying to provide full access to sound for their son with a hearing device. Melissa Tumblin stated that “Families shouldn’t have to fight to get hearing devices that would help their children thrive in life. Also, when medical professionals state that something is medically necessary, insurance companies shouldn’t have the authority to override and go against the opinion of a medical professional knowing that these children would benefit from this type of hearing device technology.” JJ Shear was fitted with his NEW Baha 5 on Tuesday, December 22nd, 2020 by Dr. Janet Lauerman in Charleston, West Virginia at the Charleston Hearing Care. Katie Shear had

JJ Shear practicing wearing a soft band head band

been preparing for this day for JJ as soon as they found out a bone conduction hearing device would be donated to him. In fact, she had purchased a soft band head band for JJ to wear for the past couple of weeks so he would be used to wearing a band on his head for when they received his Baha. Katie Shear shared with Ear Community that ever since JJ’s Baha was turned on, “he is more alert and responsive. In fact, JJ has become quite the little wild man since getting home following his appointment. Katie and Andrew Shear are grateful for JJ’s new Baha 5 and said “finding this community has been such a blessing…Ear Community is an amazing resource for new parents and families. Thank you to Ear Community and Cochlear Americas for donating a Baha to JJ! Words do not even begin to describe our appreciation to the people who have made this possible. We can’t wait to see how JJ continues to thrive every day with is Baha!”

Thank you to JJ’s audiologist, Dr. Janet Lauerman, for all the help and education she provided to the Shear Family while trying to do what was best for JJ and for helping JJ’s family appeal with their insurance providers. A special thank you to Cochlear Americas, a proud sponsor to the Ear Community Organization since 2011, for collaborating with Ear Community so both organizations, together, could help provide JJ a Baha 5 and the gift of sound! As they say, – it takes a village! Many people were involved while trying to help JJ hear. A very special thank you to Keesha Pfeiffer (Director of Volunteer Strategy & Engagement, Cochlear North Americas), Patti Trautwein (Vice President of Marketing, Cochlear North Americas) and Tony Manna (President of Cochlear North Americas) for making sure that JJ received his device in time for Christmas! “Cochlear is the global leader in implantable hearing solutions. It has a dedicated global team of more than 2,500 people who deliver the gift of sound to those with hearing loss in over 100 countries. Its vision is to connect people, young and old, to a world of sound by offering life enhancing hearing solutions. In 2013, Cochlear celebrated 100,000 Baha System users – all with unique stories of how being able to hear again has impacted their lives. The Cochlear promise of “Hear Now. And Always” embodies the company’s commitment to providing its recipients with the best possible hearing performance today and for the rest of their lives.”

Ear Community would also like to extend a warm thank you to our individual donors and members of the community who want to help us continue our work – none of this would be possible without your support! We are so happy to have been a part of helping JJ hear better! Thank you again to everyone involved who helped make JJ’s Christmas extra special by providing him with the gift of hearing!
Ear Community
www.EarCommunity.org

Introducing the ADHEAR COVID-19 Program by MED-EL

Experiencing a global public health emergency has prompted us all to do the very best we can to continue to support the communities we serve. During COVID-19, MED-EL has introduced a special program to provide prompt access to sound for candidates for a bone conduction system.

We have found that training the recipient and family on the use and care of ADHEAR is the most important part of the process. So for ADHEAR candidates who would prefer to proceed quickly to better hearing, there is no need to delay. We partner with audiologists to provide support for successful remote trainings and resources like videos, checklists and questionnaires.

The ADHEAR COVID-19 Program includes:
1. Flexible shipping options

MED-EL can offer the audiologist flexible shipping choices – direct to the recipient’s doorstep or direct to the audiologist’s clinic. This means the audiologist can handle scheduling limitations due to COVID-19 and more importantly, candidates who are not comfortable with face-to-face appointments at this time.

2. Remote orientation for the recipient

ADHEAR comes out of the box with 4 pre-defined settings, a push button for program changes and an active volume control wheel.* In fact, the software is described as an optional configuration software because these pre-defined settings are proven to be a good starting point for recipients, with equivalent outcomes to other bone conduction devices on the market. In the two years since its launch, ADHEAR has moved from innovative solution to proven concept. Click here for a review and analysis of ADHEAR results.

Once clinics return to normal operations, we recommend an in-person follow-up for any programming adjustments.
For more information, please visit:  www.MED-EL.com

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