FDA clears Cochlear’s innovative new Osia® 2 hearing implant system

The Osia System is a first-of-its-kind hearing implant system for people with SSD, conductive or mixed hearing loss


News provided by

Cochlear Limited

Dec 11, 2019, 08:00 ET


CENTENNIAL, Colo., Dec. 11, 2019 /PRNewswire/ — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today the U.S. Food and Drug Administration (FDA) clearance of the new Cochlear Osia® 2 System. The Osia System is the world’s first active osseointegrated steady-state implant (OSI), a new category of bone conduction hearing solutions that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea).

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8453251-cochlear-osia-hearing-implant-system/

The system features the new Osia OSI200 Implant that attaches to an osseointegrated BI300 Implant to send sound through the bone. The thin profile and monolithic design of the implant help to simplify surgery for the system. On the outside, the new Osia 2 Sound Processor captures sounds and sends both the sound signal and power to the internal implant. The Osia System is available to treat hearing loss associated with an array of conditions including chronic otitis media (COM), otosclerosis and atresia/microtia. In the U.S., it can be used by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD). The system delivers high power and gain and has a fitting range up to 55 dB sensorineural hearing level (SNHL).1,2

The principal innovation of the Osia System lies in the heart of the implant, which contains the Piezo Power™ transducer made of piezoelectric material. The design is completely different than traditional bone conduction transducers, and with no movement between the parts, it is designed to deliver long-term performance and durability when implanted. Driven by a wireless digital link, this transducer expands and contracts to create powerful vibrations that stimulate the inner ear while optimising transfer of power and sound quality.3 Piezoelectricity has been used for years in many products like microphones, high-end speakers and medical equipment, but this is the first time it is being used in this type of hearing implant application. One of the many advantages of the Piezo Power transducer is its ability to amplify high frequencies, the area of sound most important for speech understanding.

“At Cochlear we have been working to develop this technology for quite some time,” said Mats Dotevall, Director of Design and Development and Director of Clinical Affairs at Cochlear Acoustics. “We aimed to leverage Cochlear’s long history of innovation in both the cochlear implant and bone conduction implant spaces to create something entirely new. Rather than implanting a conventional electromagnetic transducer, we chose to work with piezoelectric material because of its unrivalled suitability for this type of implanted application. Lifetime testing shows Piezo Power technology provides powerful and consistent performance over time.”4

The Osia System has shown excellent results following a one-year, multicenter clinical investigation on a first-generation device, as well as in limited release in some clinics performing sponsored research around the world. Results of the multicenter clinical investigation show a significant improvement in patients’ ability to hear in both noise and quiet compared to unaided and aided preoperative testing.5 The Osia System has also yielded a significant improvement in ratings of patients’ overall health-related quality of life, also when compared to both unaided and aided preoperative testing.5

Findings from the full one-year clinical investigation and other data on the Osia System will be presented by the research centers at the upcoming OSSEO 2019 International Congress in Miami Beach, Florida December 11-14, 2019.

“We are thrilled to introduce the new Cochlear Osia System, a first-of-its-kind innovation in implantable hearing solutions,” said Rom Mendel, President of Cochlear Acoustics. “The Osia System was developed through our efforts to listen to the recipients and clinicians who utilize our hearing implants every day. So far, we have been overwhelmed by the positive reception of the Osia System by both clinicians and patients, and it’s been incredible to see the improvement in recipients’ lives as they are able to hear better in the areas where we know they struggle.”

The Osia 2 Sound Processor is slim and sits off the ear, providing discreet, comfortable hearing. It features the advanced signal processing and wireless connectivity technologies available with Cochlear’s leading acoustic implant systems, such as Made for iPhone technology, and it is compatible with Cochlear’s True Wireless™ accessories. The new Osia Smart App lets the user adjust the sound processor easily from a compatible smartphone or Apple Watch®.* The sound processor comes with five changeable color cover options. Additionally, the Osia 2 Sound Processor is dust and moisture resistant, and with an optional Aqua+ waterproof accessory, recipients can enjoy water activities with sound.**

The Osia 2 System will soon be available in select clinics across the United States as a part of a limited release. Full commercial availability for eligible patients is expected in early 2020. Health Canada approval for the Osia 2 System is expected in early 2020. Availability in other countries is subject to regulatory approvals.

For further information on the Osia System, visit Cochlear.us/Osia.

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,500 people and invests more than AUD$160 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 550,000 implantable devices, helping people of all ages, in more than 100 countries, to hear.

www.cochlear.com/US

References
1. Osia System Datasheet. D1618102. Cochlear Limited, Sweden 2019
2. Dotevall M. Technical Report: Available Gain in Osia vs Baha 5 Power. D1664198. Cochlear Bone Anchored Solutions AB, Sweden 2019
3. Sunnerud H. D1575584, Design Verification Report Osia System. Cochlear Bone Anchored Solutions AB, Sweden 2019
4. Goh J. OSI200 Implant Accelerated Life Test Reporter. D1439967. Cochlear Bone Anchored Solutions AB, Sweden 2019
5. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2017 March 22. Identifier NCT03086135. Clinical Performance of a New Implant System for Bone Conduction Hearing; 2019 January 31 [cited 2019 June 20]; [4 screens]. Available from: https://clinicaltrials.gov/ct2/show/NCT03086135

* For information on sound processor and app compatibility, visit www.cochlear.com/compatibility.

** The Osia 2 Sound Processor is IP57 rated with battery compartment excluded. The Osia 2 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529 when used with LR44 alkaline or nickel metal hydride disposable batteries. Refer to the relevant User Guide for more information. The Osia 2 Aqua+ may not be available in all markets and is subject to regulatory approval and product availability.

Apple Watch and iPhone 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 2019. All rights reserved. Cochlear, Hear now. And always, Osia, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB or Cochlear Limited (unless otherwise noted).

SOURCE Cochlear Limited

Related Links

http://www.Cochlear.com/US

 

National Microtia Awareness Day, November 9th 2019

November 9th is National Microtia Awareness Day!
Microtia is a congenital birth defect that occurs when one or both ears do not fully develop or are physically missing. Microtia is often accompanied by Aural Atresia – when the ear canals are underdeveloped or absent, resulting in hearing loss. Many children have associated craniofacial challenges, known as craniofacial microsomia, which affect the symmetry of the jawline causing oral challenges and a slight crooked smile. In the United States, Microtia and Aural Atresia affect 1 in every 6,000 births which is approximately 663 babies born each year. There are an estimated 54,000 individuals currently living in the United States with Microtia and Atresia.  The numbers of individuals affected by Microtia and Atresia vary regionally from country to country. While African Americans seem to be the least affected, Native American, Asian, Ecuadorian, Columbian, and Latino-Hispanic ethnicities are often affected more so. While it is not yet understood what causes Microtia and Atresia, it is possible that it is genetic. Microtia and Aural Atresia occurs during the 1st trimester of pregnancy when the ears develop.

National Microtia Awareness Day is a day that is dedicated to raising awareness and spreading knowledge. Even though this is a nationally recognized awareness day, many countries embrace our day as well. Through this national day, many can come together and find out about organizations & resources for information & support. On this awareness day, families raise awareness alongside teachers of the Deaf and Hard of Hearing with speech therapists at schools, helping talk about hearing loss and teach kindness. Many read books that have been created to share stories about children with missing ears like the book Wonder and Chelsea and Her Little Ear Make a New Friend. Medical professionals including ENTs, plastic surgeons, audiologists, and pediatricians open their doors to host educational clinics for families. Hearing loss organizations & hearing device/medical device companies all raise awareness & help educate about Microtia and Atresia by blogging and tweeting on social media platforms, by offering educational accredited courses about Microtia and Atresia and by helping sponsor organized events.

An elementary school in Colorado embracing National Microtia Awareness Day

 

 

 

 

 

 

 

 

 

 

 

It is Ear Community’s hope that families who have new babies born with Microtia and Atresia will leave the hospital armed with more answers than questions & their dreams for their children intact. If more people learn about Microtia & Atresia, they will be kinder & more accepting. It is also our goal for children & adults with Microtia and Atresia to realize that they are not alone. Facial challenges, hearing loss and the longing for social acceptance are some of the daily concerns for those who are born with Microtia. Children are born into this world not knowing they are any different from anyone else. Many with Microtia share similar stories of curious stares, bullying, or awkwardness. Individual personalities, social conditioning, available treatments and bullying all impact how every child develops and copes as an adult. By removing unnecessary boundaries and replacing them with resources, tools, and support, we can eliminate bullying and clear the way for an even more successful future.

The Tumblin Family, 2019 NMAD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The Tumblin family founded the Ear Community Organization after their youngest daughter was born with Microtia and Atresia of her right ear in 2009. The Tumblin family also established National Microtia Awareness Day to embrace Microtia and Atresia families, everywhere. Since 2010, the Ear Community Organization has brought over 15,000 people together from around the world at the organization’s events making it possible to share experiences and resources, donated over 120 hearing devices and has awarded 12 college scholarships. The community is made up of not only children and adults with Microtia and their families, but teachers, advocates, and medical professionals from all over who foster awareness and assistance for this amazing group of people. Board members for Ear Community either have the condition themselves or a family member who does, so they have close personal experience with the obstacles from a myriad of perspectives. The organization also has an advisory board made up of medical professionals who have chosen to focus their skills on helping improve the quality of life for individuals who have Microtia and Atresia.

Some of the advocacy and awareness the Ear Community Organization has set out to promote and achieve in addition to helping families and their children find acceptance is working toward finding answers as to why

Harvard Seidman Labs, Angela Tai and Barbara McDonough, Team Microtia

Microtia and Atresia occur. The organization is hopeful in finding the gene or genes in common that cause Microtia and Atresia and is on a grant with Harvard and MIT and the Broad Institute. The organization has also been working very hard at advocating for hearing device insurance coverage for bone conduction hearing devices, the only hearing devices individuals with Microtia and Atresia can wear. These very hearing devices are often not covered by private insurance providers and the organization is hopeful that by trying to mandate insurance coverage someday will become a reality for the individuals in our community. Ear Community has been advocating

Congressman McKinley’s office tweeted about National Microtia Awareness Day

on Capitol Hill in Washington, DC with with Congressmen David McKinley, Mike Thompson and Joe Neguse since February of 2019. This November 9th, we were honored to see that Congressman McKinley’s office and staff tweeted about our national awareness day spreading awareness on our special day for our community!

Each year, National Microtia Awareness Day is becoming more recognized! This year, we had (10) medical facilities host organized Microtia and Atresia clinics on or near our day to help educate these families on all of their options and to bring them together throughout the US and in other countries. Some of the clinics organized were at Stanford, Vanderbilt, and many of the Children’s hospitals including Seattle, Texas and Pittsburgh and many audiology clinics along with NYEE Infirmary and MEEI. Johns Hopkins offered a grand rounds course on rib cartilage carving workshop, honoring National Microtia Awareness Day.

An American Flag was flown over the US Capitol in Washington DC on National Microtia Awareness Day

We had clinics organized in Chile and Columbia as well, including many microtia and atresia repair surgeons spreading awareness and educating online leading up to our day. There were many organized events held all over the world from meetings to parent/teacher organized events that brought Microtia and Atresia families together throughout the US and in Australia, Canada, Mexico, Poland, Costa Rica, Argentina, Columbia, Mexico, Ireland, Chile, Denmark, Malaysia and so many more! Below are some of our memories from our National Microtia Awareness Day for 2019:

A very special thank you to all of Ear Community’s amazing sponsors who helped make our awareness day extra special for everyone! Our sponsors went the extra mile to put together beautiful memories for all us from videos educating about Microtia and Atresia to special events that were organized at their offices with treats and cupcakes in our awareness blue and educational blog posts on social media about the helpful options their companies offer that help give our loves ones the best quality of life. From hearing devices to medical device implants to prosthetic ears, thank you for all that you do to help our children and adults hear better and feel whole again!


Thank you to our Platinum Sponsors!

Cochlear Americas (Baha 5 models and accessories)
Oticon Medical (Ponto 4 models and accessories)

Thank you to our Silver Sponsors!
Stryker (Medpor)
Med-EL (ADHEAR and Bonebridge)

Thank you to all of the medical facilities throughout the US & in other countries that hosted Microtia & Atresia clinics on or around November 9th this year. A special thank you to all of the parents and advocates and teachers of the deaf & school who organized events that took place again this year, making it a special day for their loved ones who have Microtia and Atresia! We are overwhelmed with tears of joy and happiness from so many of our FB and Instagram friends who posted, blogged and tweeted about our awareness day, wearing our shirts and blue awareness color and changing their profile pictures over to our awareness ribbon. We had hundreds of pictures pour in from our FB and Instagram accounts of beautiful children and adults and their families wanting to show off their beautiful smiles and sweet little ears. To view many of these photos, please go to our support group pages on FB for the Microtia and Atresia Support Group and our Ear Community page. Thank you to Heidi Jeffs (Ear Community events manager) who requested that an American flag fly over the US Capitol in Washington, DC on November 9th for our national awareness day! This year, was also fun with our Instagram count down (thanks to board member Rachel Songy) and seeing so many families having fun with counting down to our National Microtia Awareness Day! Our community’s hearts are full today!

Remember, kindness goes a long way!
Everyone at the Ear Community Organization
www.EarCommunity.org

We also had a lot of fun videos made too!
– Microtia Columbia video: https://www.facebook.com/microtiacolombia/videos/446555226243825/UzpfSTY3NzA2Mjc0NzoxMDE1NzcxODA2NjQzNzc0OA/
– Cochlear Americas video: https://www.facebook.com/Cochlear/videos/2478674095687301/
– Oticon Medical video: https://www.facebook.com/OticonMedical/videos/514096739187119/UzpfSTY3NzA2Mjc0NzoxMDE1NzcxNjY3MzU1Mjc0OA/
– Oticon Medical video: https://www.facebook.com/OticonMedical/videos/485423735516891/UzpfSTY3NzA2Mjc0NzozMDYwNjExMjk0OTk0MTQ6MTA6MDoxNTc1MTg3MTk5OjE0OTQ4Mzc4OTY4MDA4MDY0NA/
– Stryker website: https://cmf.stryker.com/national-microtia-awareness-day
– Medel’s FB page: https://www.facebook.com/medel.unitedstates/videos/416267809089898/

 

Microtia and atresia: When ears don’t develop fully

Microtia is a rare birth defect in which the external ear is not completely developed. It affects about one of every 5,000 to 7,000 babies born annually.

Baby with microtia and atresia
Microtia is a rare condition that causes
missing or underdeveloped ears. 

Microtia usually occurs with atresia, also known as aural atresia, a condition in which the auditory ear canal is either underdeveloped, absent or closed.

Microtia and atresia almost always affect hearing and generally require ongoing medical care from a pediatric ear-nose-throat (ENT) specialist as well as an audiologist. It’s more common in males than females.

What causes microtia and atresia?

Medical professionals aren’t sure exactly what causes microtia. It’s theorized that it occurs during the first trimester of pregnancy when the soft tissues of the outer ear and middle ear are being formed. Microtia may also be linked to using skin products that contain retinol, or vitamin A, isotretinoin (Accutane) during pregnancy. It is possible that microtia is genetic.

There are four grades of microtia:

  • Grade 1—a smaller version of a typical ear with a smaller ear canal
  • Grade 2—a partially formed ear with a narrow ear canal
  • Grade 3—the external ear is missing but there may be a peanut-shaped structure made primarily of cartilage and earlobe; there is no external ear canal or ear drum (aural atresia)
  • Grade 4—absence of the entire ear, known as anotia.

Treatment options

Because this condition affects the outer ear, it is often accompanied by moderate-to-severe conductive hearing loss. Affected children are also susceptible to ear infections and may become self-conscious about their condition as they grow older. Fortunately, microtia and atresia can usually be repaired, and the hearing loss treated.

Microtia

Treatment options for microtia include:

  • Rib graft construction, a procedure in which a surgeon creates an ear sculpture from the patient’s own rib cartilage.
  • Medpor, Omnipore or Supor ear reconstruction, which involves a plastic ear frame that is covered with tissue grafted from the patient.
  • Those who choose not to have reconstructive surgery might opt for a prosthetic ear, which is secured with magnets or adhesive.

Atresia

Treatment options for atresia include:

  • Corrective surgery, in which the ear canal is widened or created.
  • Surgery to implant a bone-conducting hearing system, for those who do not wish to have corrective surgery.

Surgical risks

One of the biggest risks of surgery is damage to the facial nerve, although modern surgical techniques have substantially lowered this risk. Other complications can include stenosis (stiffening), drainage from the ear and infection.

Medical professionals recommend parents wait until children are 5-7 years old to ensure compliance with postoperative care instructions.

Advocacy and awareness

Colorado native Melissa Tumblin was inspired to learn more about microtia when her daughter Ally was born with the condition. Through advocating for Ally’s unique needs, she learned a great deal and wanted to find new ways to educate and support other parents. Tumblin subsequently founded Ear Community, an online support group and caring place for families affected by microtia and atresia.

November 9 is National Microtia Awareness Day, an observance created by Tumblin in the hopes of bringing public awareness to the rare congenital birth defect of the ear.

Detecting hearing loss in babies and kids

Newborn hearing screenings can help detect hearing loss in infants even before parents bring their babies home from the hospital. When abnormalities such as microtia and atresia are apparent at birth, or when other hearing problems are detected during the screenings, medical professionals can help you decide which treatment options are best, and direct you to the resources needed to make the right decisions.

Children with hearing loss caused by ear abnormalities are best served through a team approach led by their pediatrician or ENT specialist. Pediatric audiologists have the equipment and education to evaluate hearing loss in babies and children. They will work with your pediatrician and medical specialists to implement the best treatment options so your little one has every social, educational and developmental advantage.

Debbie Clason, staff writer, Healthy Hearing

Debbie ClasonDebbie Clason holds a master’s degree from Indiana University. Her impressive client list includes financial institutions, real estate developers, physicians, pharmacists and nonprofit organizations. Read more about Debbie.

Ear Community Organization spotlighted at the 2019 Stanford Medicine X Change Conference

On Saturday, September 21st, 2019, the Ear Community Organization and it’s Founder, Melissa Tumblin, were spotlighted in a presentation at the Stanford Medicine X Change conference, presented by well respected community leader and entrepreneur, Liz Presson, Founder and CEO of Pursuit.

There’s some serious power behind female patient advocates and is a topic that @lizpresson is speaking to more at @stanfordmedx #MedX that took place on Saturday, Sept. 21st from 2:05 – 2:25 PM PT. Liz will be sharing the stories of amazing women who are evolving the traditional healthcare system like Melissa Tumblin, Founder of @earcommunity, and Amy Edgar, Founder of Children’s Integrated Center for Success.

The title of the presentation is:
“The Power of Female Patient Advocates: Voices of women who are being heard and evolving healthcare on their own terms.”

A recorded link will become available soon. The following is the link for “live” streaming:  https://livestream.com/stanfordmedicinex/events/8808087

Liz Presson, Founder and CEO of Pursuit

A special thank you to Liz Presson!
This is an absolute honor!
– Ear Community
www.EarCommunity.org

How do you see healthcare working better for and with women? You can watch the live stream on Saturday. (Link in bio.) 📸

William receives the gift of hearing thanks to Cochlear Americas and the Ear Community Organization

William Shafer, age 3, recipient of 2 Baha 5 hearing devices, Arizona, 10/2019

Ear Community is so very happy to introduce our newest Cochlear Americas Baha 5 recipient, William Shafer, a sweet 3-year-old who lives in Arizona with his parents Jennifer and Benjamin; as well as his three siblings. When William was born, his parents soon discovered that he had a condition called Treacher Collins Syndrome. This condition can cause issues with breathing, eating, hearing loss and craniofacial challenges. Jennifer and Benjamin knew that William would have a hard road ahead of him, but they were prepared to support him every step of the way. William needed extensive feeding therapy to avoid needing to be fed via a feeding tube, and he was born with bilateral Microtia and Atresia, resulting in hearing loss in both ears.

Luckily when William was a few months old, they were able to get a loaner Baha from an organization in Arizona. However, the situation was temporary, and after some time the loaner stopped working. William, now three years old and starting speech therapy desperately needed a device (or two preferably) to help him hear! Thus, began the roller coaster of appeals with their insurance provider. Jennifer and Benjamin fought tirelessly with their insurance provider, appealing their decision to not cover hearing devices for William. Cochlear Americas even stepped in to try and help but to no avail. Sadly, William’s audiologist was at a loss and had exhausted all options for trying to obtain a Baha for him.

It was around this time when Jennifer reached out to Ear Community and shared their story. By the time their audiologist felt that she could no longer help William obtain a Baha, they tried to go through a different audiologist, but the insurance company denied covering that as well. Jennifer was at a loss and applied to Ear Community to see if our organization could help William get access to sound. When his application was presented to the board of directors, the vote was a unanimous “YES” – each board member felt so passionately about helping William, and their hearts went out to the struggle his family had been asked to endure. Ear Community was able to donate two (2) Cochlear Baha 5’s to William. On October 3rd, 2019, he was fitted with his two new hearing devices, giving him full access to sound and surround sound. Jennifer said shortly after the appointment, “Today our hearts are full. Full of gratitude towards all who made this moment possible.”

William is excited to finally have access to sound again is happy! Since being fitted, William asks to have his Baha’s on so that he can hear his parents, siblings, friends and everyday sounds. Ear Community is honored to have been a part of William’s journey and helping him find sound again. We truly could not do this without the incredible support we have from the community and to Cochlear Americas. Ear Community would like to extend a very special thank you to Cochlear Americas for donating the two Baha 5 sound processors that are helping William now thrive in life. Thank you to Paula Dyhrkopp, a local rep for Cochlear Americas in Arizona who helped get William’s Baha’s to his audiologist in record time! Thank you to Dr. Alissa Nickerson and her staff at Phoenix Children’s Hospital who took William on as a new patient and donated her time to program and fit his Baha’s. Ear Community would also like to extend a warm thank you to our individual donors, members of the community who want to help us continue our work – none of this could be done without your support. “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.”

It can be heartbreaking and exhausting navigating our way for the necessary benefits through insurance companies sometimes. Ear Community is proud to be able to help these families when other avenues have been exhausted. We are so happy for
William and cannot wait to see what he is going to do in the years to come! We wish William every happiness this world has to offer, and we are so glad that he is able to now hear everything in his corner of the world.

Good luck, William, we are so proud of you!
Everyone at Ear Community
www.EarCommunity.org

National Microtia Awareness Day is November 9th!

National Microtia Awareness Day is on November 9th!

We look forward to helping raise awareness with so many of you everywhere on National Microtia Awareness Day! The purpose of National Microtia Awareness Day is to help promote public awareness about Microtia and Atresia. As the mother of a child who has Microtia and Atresia, and the founder of the Ear Community Organization, my hope is that families who have new babies born with Microtia and Atresia will leave the hospital armed with more answers than questions, and their dreams for their children intact. If more people learn about Microtia and Atresia, they will be kinder and more accepting. It is also my goal for individuals with Microtia and Atresia to realize that they are not alone and that they have an entire community of support behind them.Through this national day, everyone can find out about organizations and resources for information and support.

The 4 Grades-of-Microtia-and-Atresia

Microtia – born with one or both ears missing or when the outer ear does not fully develop

Aural Atresia – born without an ear canal or an underdeveloped ear canal, resulting in a conductive hearing loss

Approximately 630 babies are born each year with Microtia and Atresia in the United States (affecting 1 out of every 6,000 births). Current statistics show that Latino-Hispanic, Ecuadorian, Asian, and Native American ethnicities are affected more by Microtia and Atresia where as individuals who are of African American descent are the least affected. Most families who have a child with Microtia and Atresia have never known anyone else in their family to have missing ears or congenital hearing loss, while many other families have multiple family members who are affected by Microtia and Atresia causing us to wonder if Microtia and Atresia is hereditary. It is more common for Microtia and Atresia to affect the right ear and occurs more commonly in males. Microtia and Atresia can affect one or both ears and can cause asymmetry of the face (where one jaw bone pulls upright more so on one side) known as Craniofacial Microsomia. Typically, children and adults who have Microtia and Atresia have some degree of hearing loss. Children and adults who have Aural Atresia (hearing loss) can wear a hearing device called a bone conduction hearing device (also know as a Baha, BAHS, or BAI). A bone conduction hearing device can be worn on a soft band head band (because there is usually no ear for a hearing device to be worn on) or can be implanted in the skull after the age of five.

Today, there are many options for helping someone obtain an ear who has Microtia and Atresia and who would like to live a better quality of life and be happier.
1.  The “Do Nothing” option should always be embraced with acceptance and confidence and love for oneself. Also, to remember to never let anything define you. Be YOU and be proud of who you are!
2.  There are surgical options for a reconstructed outer ear such as the rib graft surgical technique (which is the gold standard option) and different kinds of Polyethylene ear frame work options known as Medpor, Omnipore, and Su-Por. There are also other avenues for ear reconstruction that can involve soft tissue reconstruction and ear expanders to help improve the shape of an ear.
3.  There are surgical options for helping restore hearing loss and reconstructing an ear canal called canalplasty and atresiaplasty. This surgical technique can be done separately or in conjunction with a reconstructed outer ear (know as CAM – combined Atresia Microtia).
4.  There is the prosthetic ear option. This option can help someone permanently wear an ear or be a great temporary solution until deciding upon surgery or to keep their little ear just the way it is.
5.  There is a hearing device option to help someone hear better who has Atresia called a bone conduction hearing device. This hearing device can be worn on a soft band head band (since there is no ear to be worn on) or later be implanted in the skull for when the patient is ready.

The Microtia Awareness Ribbon

Here are some ideas for helping raise awareness on National Microtia Awareness Day, November 9th, 2019:

  1. Many parents, teachers, and children plan to help raise awareness at their schools. There will be talks and presentations about hearing loss and Microtia and Atresia. Many educators and parents will also be discussing differences and kindness. Everyone has something going on and it makes everyone happy to feel included, or to have someone just say “Hi” to you instead of being stared at or being treated mean in one manner or another. Many families plan to bring in sweet treats to the schools, such as cookies and cup cakes, to help embrace our awareness day and make it fun!
  2. Many medical professionals (audiologists, ENTs, and plastic surgeons) will be hosting educational clinics and blogging helpful information about Microtia and Atresia for families to learn more about their options for Microtia and Atresia.
  3. Many families, teachers, medical professionals, and supporters within the Microtia and Atresia community will be wearing awareness t-shirts, ribbons, and wrist bands, helping raise awareness about missing ears, craniofacial microsomia (craniofacial challenges), and hearing loss.
  4. Many can participate in spreading awareness through social media by simply changing your profile picture to our awareness ribbon, logo, or FB frame to help recognize National Microtia Awareness Day on November 9th! We look forward to seeing so many pictures posted of everyone in their shirts or wearing blue with our blue ribbons so we can all enjoy seeing how special our day is and the impact it has on the public (world) for so many of us who have loved ones born with Microtia and Atresia. Let’s join together and make a difference with these beautiful children and adults and their families through the Ear Community Organization on our awareness day!
  5. Many hearing loss networks such as AudiologyOnline, organizations like the EAA and ASHA, and medical device companies will be blogging about our National Microtia Awareness Day on social media in hopes of helping raise awareness about Microtia and Atresia, helping support our Ear Community Organization, and to help educate everyone about “all” options for missing and underdeveloped ears, hearing loss, and facial challenges and in hopes that everyone will be kinder and more understanding.

Thank you, thank you to everyone for embracing our awareness day and for supporting our children and adults who have Microtia and Atresia in our community. Thank you to all of the families, classroom teachers and teachers of the Deaf and HoH, therapists, audiologists, ENTs, pediatricians and general practitioners, and plastic surgeons for helping educate on our day and for taking the time to learn more about Microtia and Atresia to help teach others. Thank you to everyone who will be blogging on social media and publishing articles to helping raise awareness on November 9th! Thank you very much to everyone who has helped support our Ear Community Organization and it’s mission to help children and adults who have Microtia and Atresia!

A special thank you to Ear Community’s amazing sponsors for also helping raise awareness about Microtia and hearing loss and for making our events possible and for offering advanced technology that helps our children and adults in many ways. Thank you also to our sponsor companies and the employees who stand behind these companies and their technology that give our loved ones a better quality of life!

Thank you to Ear Community’s Platinum Sponsors:
Cochlear Americas (Baha 5 and SoundArc sound processor)
Oticon Medical (Ponto 3 Superpower, Ponto 4 and streaming device)

Thank you to Ear Community’s Silver Sponsors:
Med-EL (ADHEAR and Bonebridge sound processors)
Stryker CMF (Medpor outer ear implants)

Ear Community proudly awards it’s 12th college scholarship

Gabrielle E. Ayala-Montgomery, Ear Community college scholarship recipient, September 2019, Washington.

Ear Community is pleased to introduce you to the beautiful Gabrielle E. Ayala-Montgomery, our second College Scholarship applicant for the year! Gabrielle reached out to us this Summer and shared a little with us about her desire to become a lawyer.

Gabrielle was born with Microtia and Aural Atresia of her left ear as well as craniofacial microsomia. As a result, she experienced a decade of orthodontia and lives with significant hearing loss on her left side. Medical professionals tried to tell her parents that she would struggle in school, and it would be difficult for her to succeed academically. Well Gabrielle is a fighter and proved them all wrong! She studied hard and more than excelled in school. She was consistently on the Dean’s List and graduated High School Phi Beta Kappa.  Gabrielle said, “I realized that my disability was only a societal limitation if I allowed it to be.”

Her experiences pushed her to pursue a degree to help others navigate the judicial system and grant them the fairness they deserve. Gabrielle also shared that she is of Mexican descent and has embraced her Mexican-American identity. Since starting college, Gabrielle has begun taking Spanish classes to be able to communicate with extended family members, and she has been involved with organizations that help mentor at-risk youth in her community. In her application letter, Gabrielle shared, “the rediscovery of my culture and language has helped me realize that a career in international, immigration, or civil rights law will help me fulfill a personal obligation, paving the path for a more just future for others – especially disadvantaged populations.”

Gabrielle has a true passion for helping others who live in the margins of society, because she has been there and walked those paths. Ear Community is honored to award her a $750.00 scholarship for furthering her education. Gabrielle will be finishing her law degree at the University of Washington Law School and will graduate in 2022. We cannot wait to see the difference she makes in the world, as she is a true force to be reckoned with!

Ear Community would like to extend a warm thanks to all of our supporters and donors who make scholarships like this possible. We could not continue this important work if it weren’t for the continued support we get. We would also like to thank Tortoise Advisers and Brent Newcomb for helping us be able to award Gabrielle’s scholarship. Brent is a brother to one of our board members, Scott Newcomb, and we are so grateful for their passion and support.

Gabrielle, we wish you the best of everything as you finish up your law degree and will watch anxiously at the life-changing work you will do in the lives of so many!

Little boy receives the gift of hearing thanks to Oticon Medical, Ear Community and school professionals in Virginia

Brian Campos Valladares, recipient of 2 Oticon Medical Pontos, September 17th, 2019, Virginia

Often times Ear Community works with various early intervention services, and other professionals who support children with Microtia and Atresia. This past Summer, a school nurse, Danielle Vukadinovich, reached out to us in an effort to help one of the students at the school she works at. Brian Campos Valladares, a 9-year-old boy with Bilateral Microtia and Aural Atresia. Brian and his mother recently relocated to the United States from El Salvador where they had to leave Brian’s father behind.

When we first heard about Brian’s situation, our hearts poured out to him. Here was a little boy, in a strange new country, where everyone spoke a different language that he couldn’t even hear. Growing up in El Salvador, Brian was exposed to Spanish from his parents, but being as he has Bilateral Microtia and Atresia – resulting in moderate to severe hearing loss, he could barely hear what his parents tried to say to him. Brian and his mother, Yancy, have been fighting every day to create a better life for themselves and part of that was Brian getting a good education.

Danielle helped Brian get a hearing test done, and the school was able to help him get a loaner Baha to use temporarily for school so he could learn English quicker as well as have more access to sound. He is attending a new school this year in Virginia that is specifically for the Deaf and Hard of Hearing, which will be so great for him to be around other kids like him and where teachers have a deeper knowledge base of hearing loss and how to work around it.

When Brian’s application first came to Ear Community, our board voted a unanimous ‘YES’ to help him with 2 Oticon Ponto’s so he could have full access to sound! We have an incredible Board of Directors who have such a passion for helping children gain equal access through sound. Brian’s journey wouldn’t be complete without us thanking several key individuals. First of all, of course is Brian’s mother Yancy – who has worked tirelessly to provide a better life for her son. Danielle Vukadinovich, a school nurse who went above and beyond to help a student assimilate into his new country and school. Leslie Viladegut, Brian’s case manager who helped to facilitate the details of his fitting. Thank you to Yenny who worked closely with Brian’s case at the audiology office. Also, a very special thank you to Dr. Mary Finkbone who donated her time to program and fit Brian’s devices.

On September 17, 2019, Brian was finally fitted with his “new ears” and he was thrilled!  Oticon Medical even sent a stuffed animal “Massie” monkey that has a Ponto and he named his “Brando”.

A very special thank you to Alan Raffauf, Vice President of Marketing and Operations for Oticon Medical US, for choosing to donate the two new Oticon Medical Ponto 3 Superpower hearing devices to Ear Community so that they could be donated to Brian to help him hear better. Thank you to Beverly Ostrowski, Director of Customer Service, with Oticon Medical for helping ship Brian’s hearing devices. 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.”

Lastly, to Brian – thank you for allowing us to be a part of your journey, may you hold your head up high and savor each moment that life gives you. We cannot wait to watch how you soar now that you have full surround-sound and can thrive at school, home, and making new friends!

UPS Kentucky helps Ear Community ship hearing devices to children in need thanks to grant

       The James McClellan Family

Ear Community would like to extend a special thank you to UPS of Kentucky and to Melissa and James McClellan for their generous donation. James McClellan works for UPS and his family decided to apply for a grant through his employer for Ear Community on behalf of their son, Jamison, who has Microtia and Atresia.

Because of UPS’s generosity, Ear Community was able to ship an Oticon Medical Ponto 3 to Jay-Dee, a little boy who lives in South Africa who has Microtia and Atresia, including Treacher Collins Syndrome.  The story of how Jay-Dee got his device can be found here on our website. UPS made it possible for us to help not only one child with the gift of sound, but also provide peace and closure to another family by honoring their wishes of donating their beautiful daughter’s devices to a child in need.

Ear Community strives to help all individuals with Microtia and Atresia, and part of that is donating hearing devices around the world to families that cannot afford them. Often times the shipping costs are substantial, especially with customs and taxes. Companies like UPS who offer shipping grants make it possible for our organization to continue our mission of helping every person who has Microtia and Atresia, no matter where they live.

Earlier this Summer, Ear Community donated two devices to a little boy in the Philippines, Austin. Austin’s story can be found here. We were so happy to be able to ship those devices through UPS and know that they would arrive intact, and on time for Austin’s fitting. Thank you so very much to the McClellan family and to UPS for their generous donation – it is directly because of your donation and this grant that we have been able to change lives! Our Ear Community Organization is also proud to allow Microtia and Aural Atresia families the opportunity to help give back too! We hope your son, Jamison, is smiling ear to ear because of his family helping other children receive the gift of hearing!

Ear Community advocates for hearing device insurance coverage on Capitol Hill in Washington, DC

Melissa Tumblin and Rachel Songy of the Ear Community Organization, Washington, DC 9.2019

September 19th and 20th, 2019 – On September 19th, Founder and Executive Director of the Ear Community Organization, Melissa Tumblin, met with Congressmen Mike Thompson (D-CA) and David McKinley (R-WV), both of the Congressional Hearing Health Caucus, and Congressman Joe Neguse (D-CO), from Melissa’s home state, to advocate for hearing device insurance coverage for bone conduction hearing devices. After flying into DC from Colorado, the following day Melissa Tumblin was notified that the meeting that had been scheduled with Congressman Mike Thompson, for both her and Ear Community Board Member, Rachel Songy, had been cancelled. Our meeting with Congressman Thompson had been suggested by Congressmen David McKinley’s office after Rachel Songy had met with McKinley in July. Once finding out that Congressman Thompson was unavailable for the rest of the week, Melissa figured she would make the most of her day since this was the whole purpose of her trip to DC. Feeling hopeful, Melissa took a chance and headed to each Congressman’s office in hopes of still being able to meet with someone. To her surprise, she was able to meet with all three Congressmen unannounced, given the opportunity to discuss why hearing device insurance coverage is an issue for bone anchored hearing devices for both children and adults. Each Congressman took the time to meet with her, listening to her concerns. She explained the problem regarding lack of insurance coverage by private insurers for these hearing devices and explained how some children are born without ears, have no ear canals and that these are the only hearing devices they can benefit from. Congressman Mike Thompson and Senior Legislative Assistant, Crozer Connor, took the time to meet with Melissa at the last minute before heading to the floor for a bill after finding out she had flown in from Colorado to meet with him and their meeting had been cancelled that day. Melissa discussed the challenges with private insurers and the lack of coverage for these devices with them, asking for help on a national level. When meeting with Congressman David McKinley, Melissa’s story of all of the children and adults who continue to be denied by their insurance providers resonated with him as he is the only member of Congress who wears a cochlear implant and his grandson wears a bone conduction hearing device, the same hearing device her daughter, Ally, wears. Congressman McKinley invited his insurance specialist in to briefly listen to some of the stories of insurance denials that Melissa shared with them. When meeting with Congressman Neguse – he took the time to listen, along with two of his staff members and Legislative Assistant, Katie Wallace, who all tried on the bone conduction hearing devices Melissa had brought with her. Congressman Neguse was shocked to hear how many children and adults are denied the use of a hearing device and that these hearing devices are often not covered throughout adulthood by private insurers. His office also retrieved the letter that Melissa’s daughter had written to him during Better Hearing and Speech Month (May), where Ally asked him to help her advocate to hear better.

During the next day on September 20th, Ear Community Board Member Rachel Songy and Melissa Tumblin were able to meet with Crozer Connor (Senior Legislative Assistant to Congressman Thompson) after rescheduling the meeting from the day before. Both, Rachel and Melissa were able to speak in more detail with Crozer Connor, again asking for his help with hearing device insurance coverage on a national level. We are hopeful that our voices were heard and we will continue to advocate moving this process along in hopes for coverage of bone conduction hearing devices nation-wide.

https://www.youtube.com/watch?v=tcGqW-_zETw

On February 26th, 2019, the Ear Community Organization began advocating on Capitol Hill for hearing device insurance coverage for bone conduction hearing devices during Advocacy Day. The organization brought eight Ear Community families along, including one medical doctor, from states including Washington, Virginia, West Virginia, Washington, DC, Maryland, Tennessee and Colorado. Ear Community families advocated for hearing device coverage alongside the NIDCR (National Institute for Dental and Craniofacial Research), AADR (American Association for Dental Research) and FNIDCR (Friends of National Institute for Dental and Craniofacial Research) with Melissa Tumblin being a member of the Patient Advocacy Council for these dental and craniofacial research

Ear Community Families advocating in Washington, DC 2/26/2019

organizations. The families advocated for half a day on Capitol Hill, meeting with local Congressmen and Congresswomen. Ear Community also helped advocate for research funds with the NIH for the NIDCR and AADR. The day was an amazing experience for all and we were grateful for the opportunity provided.

Congresswoman Abigail Spanberger meeting with Mazie Herzing, Ear Community hearing device recipient

While advocating on Capitol Hill during Advocacy Day, Congresswoman Agibail Spanberger (D-VA) and Senator Tim Kaine (D-VA) were able to meet directly with two of our Ear Community Families (Shelley and Carly Herzing with their daughter, Mazie and Ear Community support group administrator, Kasi Logan (and her daughter, Ella) and Family). Congresswoman Spanberger and Senator Kaine were thankful to meet Mazie and the Herzing Family and the Logan Family. Both representatives were proud of these two families for helping advocate for children and adults who have Microtia and Atresia in the state of Virginia. Mazie Herzing is a bone conduction hearing device recipient from Ear Community and was awarded a Cochlear Americas Baha 5 when Mazie’s family insurance provider in the state of Virginia denied coverage for her hearing device.

While advocating on Capitol Hill with the NIDCR/AADR, our Ear Community children that were

Ear Community kids meet Gaten Matarazzo from Stranger Things

with us were very lucky to meet Gaten Matarazzo from the Netflix Science-Fiction drama series , “Stranger Things.” Gaten was there with his father, Gaten Sr., advocating for a cause that Gaten supports called cleidocranial dysplasia (CCD) – a condition he was born with that affects the development of bones and teeth. Melissa Tumblin and her two daughters, Hailey and Ally, were also invited to the NIH where they were given the opportunity to participate in director lead meetings by the NIDCR and AADR.

During the month of May, while continuing to advocate for hearing device insurance coverage, Ear Community’s co-founder, Ally Tumblin (co-founder of Ear Community), wrote letters to Congressman Joe Neguse (D-CO), Congressman David McKinley (R-WV), Congressman Mike Thompson (D-CA) and Senators Corey Gardner (R-CO) and Michael Bennet (D-CO) as a home work assignment in support of hearing loss, a cause that is near and dear to

Ally Tumblin of Ear Community, writing letters to House and Senate members during Better Speech and Hearing Month (May 2019)

Ally’s heart as she has severe hearing loss in her right ear. These letters were sent during the month of May in honor of Better Hearing and Speech Month with Ally asking for help with mandating hearing device insurance coverage for bone conduction hearing devices. Ally chose this homework assignment so she could help advocate for other children and adults who were born with Microtia and Aural Atresia. This home work assignment was a great way for Ally to follow up with her House and Senate representatives and staff that she had met with back in February.

Thank you and we’ll keep everyone updated as we continue to advocate for our community!
Ear Community
www.EarCommunity.org

Here are more memories from our special advocacy days:

 

Translate »