Cochlear receives FDA clearance to lower the age for the Osia® System to 5-years-old

June 11, 2024 By Leave a Comment

April 19th, 2024

Cochlear Americas Osia System

Cochlear Americas Osia System

Media Contact
Christy LaPlante
Public Relations Manager
Cochlear Americas

pr-cochlearamericas@cochlear.com

  • In the United States, the Osia System is now cleared for children ages 5 and older
  • The Osia System, which launched commercially in 2020, is indicated for people with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD)
  •  The Osia System has been shown to provide clinically significant improvements in high frequency hearing for children.2,3,4

Lone Tree, Colo. (April 19, 2024) – Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) clearance to lower the age of the Cochlear™ Osia System from 12 years-old to 5-years-old for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD).

The Osia System is 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). It is the first and only active bone conduction system that allows patients to undergo MRI scans at both 1.5 T and 3.0 T without the need for surgery.1

Now children as young as 5 will be able to have full access to the Osia System’s unique technology that is optimized to deliver high power and clarity, especially in high-frequency sounds, which are important for hearing what others are saying.

“I love my Osia System. It’s given me the confidence to succeed in school. I can hear everything my teacher and my friends say,” Adrian R., 8-year-old Osia System recipient said.

Adrian was diagnosed with hearing loss at age 4 and started with the Baha® Sound Processor with a Baha Softband before transitioning to the Osia System at age 6.

Happy Adrian_Bone conduction solution Adrian with osia sound processor.jpg

“It has been amazing to see the transformation in Adrian. She has been doing so well in school and is able to keep up with her friends both in school and out. She is even learning the piano now and I never thought I would be able to say that. It has truly been life changing,” Dea R., parent to 8-year-old Adrian said.

The Osia System has been shown to provide clinically significant improvements in high frequency hearing for children.2,3,4

“I choose the Osia System for my pediatric patients because it really made the difference in terms of the sound clarity. It is absolutely incredible,” Dr. Daniela Carvalho, Pediatric Otolaryngologist at Rady Children’s Hospital said.

“All of my patients with the Osia System have come back to my office saying it’s the first time they’ve heard the birds chirping or other high-frequency sounds.”

Cochlear’s product portfolio is inspired by meaningful innovation and a core belief that technology is only as useful as the benefit it provides.

“The Osia System is transformative technology, and we’re pleased that it’s now accessible for children as young as 5. This aligns with our commitment to empower people across all stages of life to stay connected and thrive,” Lisa Aubert, President, Cochlear North America said.

 

Disclaimer

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.

Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.

For a full list of Cochlear’s trademarks, please visit our Terms of Use page.

Filed Under: Events, History

Happy 14th Birthday to the Ear Community Organization! – May 20th, 2024

May 20, 2024 By Leave a Comment
Happy 14th Birthday to Ear Community!

Happy 14th Birthday to Ear Community!

Micotia Kids Rock!

Microtia Kids Rock!

TODAY, May 20th, is Ear Community’s Birthday! Our organization is 14 years old!

Ear Community is the first parent-driven nonprofit to serve the microtia and atresia community. Our organization is proud to have paved the way for our community with genetics research, research that will improve health care for our community for both the medical professional and patient and we are proud to advocate for what our community needs in regard to insurance for hearing devices! Our organization has done so much over the years and we are so proud to be able to continue giving back to our community as we continue our mission of helping our beautiful children and adults with microtia and aural atresia!

So far this year:
– Ear Community has already donated (2) hearing devices to two children in need with a third donation in process! Since 2012, our organization has donated over 175 BAHA devices to those in need!
– Ear Community has helped 2 children with find funds for their fitting/programming fees that were denied by their insurers. We have helped 2 audiologists still be able to give the gift of hearing through our Pax’s Ear Fund program specifically meant to help with this issue. Since last year, we have helped 10 individuals receive the gift of hearing!
– Ear Community has continued to advocate on Capitol Hill in Washington, D.C. for Ally’s Act, H.R. 2439/S. 1135 – our Federal piece of legislation that our organization has in place that will prevent private insurers from denying Bone Anchored Hearing Devices! With passage of this bill, our children and adults will be able to have these hearing devices covered from birth to age 64!
– Since 2011, Ear Community has hosted over 125 priceless events for our community in many different countries! We are looking forward to our upcoming events that begin on June 1st in the US and in Canada for this year!
– Ear Community has awarded over 20 college scholarships too!
– Ear Community has new findings through our research that show microtia and atresia are genetic on chromosome 3!
– We also look forward to everyone embracing our National Microtia and Atresia Awareness Day this November 9th when the world recognizes our rare cause on our special day!

Our community is very important to us and we could not have our organization without our donors. Thank you to everyone who helps give back to our community through Ear Community! ❤👂

Please show us your support by helping give back to our May fundraiser, which is one of our main fundraisers during the year! So far, we only have $30 donated of our $5,000 goal and the chance to help give back ends on the last day of May! Please help us continue our mission of helping give back to our beautiful microtia and atresia community!

Ear Community
or
Our FB fundraiser at the following link:
Filed Under: Events, History

May 3rd is Good Vibrations Day | Bone Anchored Awareness Day

April 30, 2024 By Leave a Comment
Good Vibrations Bone Anchored Awareness Day May 3rd

Good Vibrations Bone Anchored Awareness Day May 3rd

Gothenburg

22 April 2024
Oticon Medical will celebrate the fourth annual Good Vibrations Day/Bone Anchored Awareness Day on May 3rd, 2024. This non-branded occasion was developed to raise awareness of bone conduction as an effective hearing treatment alternative for those with conductive, mixed, or single-sided hearing losses. Participation is open to all bone conduction device manufacturers, audiology professionals, and wearers with the goal of raising awareness of this treatment and celebrating its benefits worldwide.

Why May 3rd?
The May 3rd date was chosen because it is the birthday of Per-Ingvar Brånemark, a Swedish physician and research professor known as the father of osseointegration, and the godfather of bone anchored hearing. His discoveries enabled the development of modern bone conduction hearing devices.Wearers are encouraged to share video clips, photos, and stories depicting their lives with a bone anchored hearing system. Hearing care professionals are also invited to share their experiences fitting the devices and the benefits their patients have enjoyed.“I think a bone anchored hearing system supports an individual’s listening experience by simply giving them access to language and the sound in their environment,” said Educational Audiologist Elaine McCarty. “Being able to know what’s happening in their environment, connecting with other people, I think it’s a big one. Bringing that oomph to their system with the use of a tool like the bone anchored hearing system to give them better access to that.”How Bone Conduction Works
Bone conduction hearing systems treat hearing loss by bypassing missing or damaged portions of the wearer’s outer or middle ear and sending vibrations via the skull directly into the cochlea. From there, they are processed by the brain as sound. More than 400,000 people around the world use some form of a bone conduction hearing device and have benefited from the treatment.

A Global, Non-branded Day of Celebration
Leading up to and including May 3rd, Oticon Medical invites all bone conduction device manufacturers to join them in celebrating Good Vibrations Day, along with wearers, parents and caregivers to wearers, and hearing care professionals. Activities can include sharing experiences, information, and videos and photos from wearers, holding contests, and more across various social media platforms.

“As we mark our fourth year celebrating Good Vibrations Day,” René Govaerts, General Manager at Oticon Medical, affirms, “our dedication to the importance of sound remains unwavering. This momentous occasion has served as a significant day for raising awareness about the remarkable benefits of bone conduction. Given that many people around the world are still unaware of bone anchored hearing systems as a viable solution for their hearing loss, it’s imperative that we work to change this. Oticon Medical remains committed to advancing our collaborative efforts with other manufacturers, hearing care professionals, and current wearers to ensure that the transformative capability of bone conduction reaches all those in need.”

Good Vibrations Day posts, stories, tweets, reels, etc. can be shared by all using the #GoodVibrations and #BoneAnchoredHearing hashtags. They can also be viewed and shared via the official Good Vibrations Day Facebook Page: www.facebook.com/boneanchoredhearing. Hearing care professionals and wearers alike are encouraged to join this Facebook Page.

Media Contact:

Erik Lund
Marketing Director, Oticon Medical
E-mail: erld@oticonmedical.com
Mobile: +46 76 304 4482

About Oticon Medical

Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. For more than a decade, we have made bone anchored hearing systems more accessible by simplifying the treatment for physicians, audiologists, and patients alike.

We believe that patients and hearing care professionals should be able to choose the best possible solution at any time along the patient journey. We call it “Freedom of Choice” and it has always been paramount to Oticon Medical. This is the reason why our solutions are designed to be compatible whenever possible. As a result, an implant from Oticon Medical stands as a true testament to our unwavering lifelong support.

We work collaboratively with professionals to ensure that every solution we create is designed with our users’ needs in mind. We have a strong passion to provide innovative solutions and support that enhance quality of life and help people live life to the fullest – now and in the future.

Because we know how much sound matters.

More information can be found at www.oticonmedical.com

Filed Under: Events, History

Ear Community exhibits at the 2024 EHDI Meeting in Denver, CO

April 5, 2024 By Leave a Comment

Caitlin Hurst, Melissa Tumblin and Melissa McClellan of Ear Community at the 2024 EHDI Meeting in Denver.

Our Ear Community Organization was proud to exhibit at the 2024 EHDI (Early Hearing Detection and Intervention) Meeting held in Denver, CO this week! Our booth was busy with audiologists, therapists, educators, doctors, researchers and parents coming to our booth for information on microtia and atresia! This was Ear Community’s 6th time being a part of the EHDI Meeting over the years.

We always have attendees who search for our booth looking to find out the latest information and options for microtia and atresia. We had parents attend, some even wore their Ear Community Microtia and Atresia Kids Rock t-shirts, which was awesome to see! Thank you to the organizations at EHDI who also endorse Ally’s Act, H.R. 2439/S. 1135! It was great seeing our organization’s Sponsors too (Cochlear Americas and MED-EL USA)! It was wonderful seeing so many friends and familiar faces and also new friends too!

Thank you to Caitlin Hurst, Melissa McClellan, Natasha Irwin Rich, Elizabeth M Desloge and Keesha Pfeiffer for all joining us in our booth as parents of microtia and atresia kids! Elizabeth hosts our National Microtia and Atresia Awareness Day event each year in California and Natasha will be our Florida picnic host this June in collaboration with Nemours Children’s Health. Melissa McClellan is an amazing past board member of Ear Community who has enjoyed attending EHDI over the years with us and Caitlin and Melissa educated their hearts out about microtia and atresia! We had a special surprise – Caitlin and I discovered both of our kids had the same amazing teachers for speech during school over the years even though they are 6 years apart (Carm and Jeannine stopped by to see us)! We had audiologists and early intervention specialists who came to EHDI just to see us, especially audiologists who were born with microtia and atresia! We had a family attend coming all the way from Hawaii who visited with Caitlin as they both have had outer ear reconstruction with their kids and Dr. Tahiri Plastic Surgery! We shared about our picnic schedule with attendees to our booth along with the programs and work our organization offers as well! Ear Community is also proud to always include our children by honoring them in the booth with their pictures too! The last time Ear Community exhibited with EHDI in Denver in 2018, our organization’s Founder, Melissa Tumblin, was the recipient of the EHDI Family Leadership in Excellence Award!

Here are some fun memories from this week at EHDI while joining many of our friends and industry partners helping educate on all things Deaf and Hard of Hearing, especially on microtia and atresia! It was wonderful to see everyone this year at EHDI! 👂❤️
Thank you!
Ear Community

Filed Under: Events, History

Ear Community launches Pax’s Eyewear Fund offering eyeglasses & sunglasses for children with microtia & atresia

April 5, 2024 By Leave a Comment

Pax’s Eyewear Fund is made possible by a sweet little boy named Pax who was born with microtia and atresia. Pax and his family know how important it is to help children have the eyeglasses and sunglasses they need, but glasses that can stay up when they are missing ears. Ear Community is grateful for Pax’s Eyewear Fund! Pax’s Eyewear fund gives Ear Community the opportunity to help give back to our community when helping members of the microtia and atresia community see.

James Hermsen of Adaptive Eyewear Solutions is a friend of our organization who has helped provide microtia glasses for our community since 2017 at our picnics. James is the passionate soul behind making these eyeglass and sunglasses with straps and adapter, including fittings to keep bone anchored hearing devices on as well. James can be reached directly at: getunhinged@gmail.com  if you are in need of glasses for a child who has microtia and atresia. James can also fit existing sun or eyeglasses with his adapters and straps as part of our Ear Community Pax’s Eyewear fund if your child should already have a favorite pair of eye or sunglasses. To learn more about this eyewear for children with microtia, please click here.  * Please tell James you learned of his eyeglasses and sunglasses for microtia kids through Ear Community when reaching out to him.

It is Ear Community’s goal to help as many children with microtia as much as possible in. We are grateful to Pax and his family for making this fund possible through our Ear Community Organization!
Thank you,
EarCommunity.org

Filed Under: Events, History

Ear Community receives grant from Broomfield Rotary Club for local summer event

March 25, 2024 By Leave a Comment
Ben Vagher of Broomfield Rotary Club awarding Melissa Tumblin of Ear Community a scholarship for local summer event

Ben Vagher of Broomfield Rotary Club awarding Melissa Tumblin of Ear Community a scholarship for local summer event

 

 

 

 

 

 

 

 

 

 

 

Thank you to Rotary Club of Broomfield for recognizing the wonderful work the Ear Community Organization does, both locally and globally! Yesterday, Ear Community, was awarded a grant by the Rotary Club of Broomfield that will go toward our Broomfield event in July, helping bring children and adults and their families together on an educational day for our community! It was an honor to be given the opportunity to present and educate about microtia and aural atresia and what Ear Community does to give back to our community, including all of the work we have done over the past 14 years!

A special thank you to Benny (Ben) Vagher and Justin Schierkolk for being so kind and supportive, but for also getting me in front of Broomfield Rotary Club to share about how Ear Community changes lives and all the good our organization does for our rare cause! Thank you also to Rotary International for helping match the funds raised by our local Broomfield Rotary Club! Your support is amazing and our organization is grateful for this grant!

Thank you so much for giving back to the community through Ear Community and thank you for hearing our story! Your support is appreciated more than you know and means the world to our community! 👂 ❤️
Melissa Tumblin
Founder – Executive Director
Ear Community
Filed Under: Events, History

Ear Community is awarded the Charlie F. Cronheim Memorial Grant by Reconstruct Together

March 15, 2024 By Leave a Comment

Ear Community is recipient of the Charlie F. Cronheim Memorial Grant through Reconstruct TogetherOn January 31, 2024, the Ear Community Organization was awarded the Charlie F. Cronheim Memorial Grant, by Reconstruct Together – a nonprofit organization that aims to sponsor established humanitarian missions in need of funding that serve the reconstructive needs of patients in communities around the world. Reconstruct Together’s Board of Directors honored Ear Community for the work the organization does for the microtia and aural atresia community. “Our organization is proud to be a Charlie F. Cronheim Memorial Grant Recipient,” says Melissa Tumblin, Founder of Ear Community. I have had the pleasure of knowing Dr. Angelo Leto-Barone, President and Founder of Reconstruct Together, for the past eight years while working together to help patients in the microtia and atresia community. Dr. Leto-Barone is a wonderful plastic surgeon and friend who has dedicated his life to helping patients in need of microtia repair, cleft lip and palate repair and more.”

Thank you to Reconstruct Together for offering support to other advocate organizations and medical professionals in our community who are in need and share the same vision! Many of the communities like the microtia and atresia community are underserved communities needing additional help whenever possible. Thank you for helping give back to the community and by helping change people’s lives! Reconstruct Together’s grant is appreciated more than you know and will help many in the microtia and atresia community go on to live better quality lives!

To learn more about Reconstruct Together’s organization and mission, click here.

Here is a lovely video Reconstruct Together made when honoring our Ear Community Organization and the work we have done for the microtia and atresia community:
https://www.youtube.com/watch?v=CznyIPfUuO0

Here is more on Ear Community’s work and mission.

Again, Ear Community is honored to be a grant recipient! Thank you to the Board of Directors at Reconstruct Together for selecting our organization to help give back to and support!
Melissa Tumblin
Founder – Executive Director
EarCommunity

Filed Under: Events, History

Ear Community Microtia and Aural Atresia summer events schedule for 2024

March 15, 2024 By Leave a Comment

Ear Community logo

 

 

 

 

 

 

 

 

 

 

 

 

 

Ear Community hosts picnics every year around the world helping bring Microtia and Atresia families together. This year’s picnics will take place in the United States in Orlando, Florida/ Fullerton, California/ Calgary, Canada/ Edina, Minnesota/ Broomfield, Colorado/ New Orleans, Louisiana and Laval, Quebec Canada! It is very exciting for many families! Everyone enjoys attending our picnics and our Ear Community picnics always offer such a wonderful opportunity for Microtia and Atresia families to come together, share experiences with each other, and maybe even make a new friend. Medical professionals such as world renown Microtia and Atresia repair surgeons, anaplastologists, ENTs, audiologists, and therapists along with the world’s leading hearing device companies all come together to mingle with us at our picnics, helping educate us on all of our options including hearing loss.

Ear Community Texas microtia and atresia picnic

Ear Community Texas microtia and atresia picnic

Event locations for 2024

June 1st – Orlando, Florida (in collaboration with Nemours Children’s Health)
June 22nd – Fullerton, California (in collaboration with Dr. Tahiri Plastic Surgery)
June 22nd – Calgary, Canada
June 29th – Edina, Minnesota (in collaboration with Children’s Minnesota Hospital)
July 13th – Broomfield, Colorado
July 20th – New Orleans, Louisiana
July 27th – Laval, Quebec Canada
* To RSVP, send an email to Caitlin at:  CaitlinEarCommunity@gmail.com

Our events are held outdoors providing a relaxed environment and so the kids can play.

A special thank you to our amazing Ear Community Sponsors!
Platinum Sponsor – Cochlear Americas
Gold Sponsor – Oticon Medical
Silver Sponsor – MED-EL USA

A special thank you to the Blue Chip Foundation, The William, Jeff and Jennifer Gross Family Foundation, the Omnium Foundation, the Emily Hall Tremaine Foundation and the Every Kid A King Foundation for helping make our special days possible and for helping provide the much needed support to our organization it needs on many levels!

Ear Community’s events are made possible thanks to our organization’s proud sponsors, donor organizations and our community contributors! Without the continued support of our sponsors, donor organizations and community contributors, we would not be able to bring our Microtia and Atresia families together at our events as we have done for more than a decade. We also would not be able to work on all of the research and studies that our organization contributes to that help benefit our community in the future without the help of public contributors. Ear Community is thankful and appreciates the continued support from all of our supporters! Your support means the world to our families, our community and to our organization!

We look forward to seeing everyone at our Ear Community picnics this year!
Melissa Tumblin
Ear Community
Microtia and Atresia Support Group on Facebook

Filed Under: Events, History

Auregen Biotherapeutics is actively enrolling individuals with microtia!

March 6, 2024 By Leave a Comment

For the past eight years, Ear Community has been collaborating with Auregen Biotherapeutics for an ear of the future that would help children and adults born with microtia and atresia. Last fall, Auregen began clinical trials on 3D printed regenerated ears that would help individuals born with unilateral microtia.

Auregen Bio is actively enrolling individuals who have unilateral microtia for the opportunity to have a 3D printed regenerated ear created! This is an ear made from your own ear’s cellular material, resulting in an ear that would be a living ear offering more flexibility just like the other existing non-microtic atretic ear. Ages for enrollment are from 12 to 29 years of age. If interested, please reach out via email at: ClinTrials@Auregen.bio

Clinical trials are accepting Spanish and English speaking families here in the US, but welcome individuals and families from any country to participate. Auregen Biotherapeutics will also be a part of Ear Community’s picnics taking place this summer across the US and Canada.

Thank you,
Melissa Tumblin
Founder – Executive Director
Ear Community

Filed Under: Events, History

We want Ally’s Act, H.R. 2439/S. 1135 to pass!

March 3, 2024 By Leave a Comment
We want Ally's Act, H.R. 2439 and S. 1135 pass

We want Ally’s Act, H.R. 2439 and S. 1135 pass

WANT BONE ANCHORED HEARING AIDS and COCHLEAR IMPLANTS COVERED BY PRIVATE INSURANCE?

HERE’S HOW YOU CAN HELP ADVOCATE FOR ALLY’S ACT, H.R. 2439 and S. 1135 TO PASS!

Are you tired of private insurance companies denying coverage for Osseointegrated Devices/BAHA or Cochlear Implants? Are you tired of insurance companies dictating who gets to hear and who does not? Then, help advocate for Ally’s Act, H.R. 2439 and S. 1135 to pass!

Private insurers should not have the authority to override medical necessity when our doctors state that bone anchored hearing devices help our loved ones hear! It is incredibly difficult to get legislation in place to change the law, but we did it with Ally’s Act! Ally Tumblin is the child who inspired this bill after seeing how many people in our community are denied these specific hearing devices. Please help us advocate to help pass Ally’s Act into law!

We need everyone from our community to reach out to the offices on these attachments, especially your own Congressman and Senators. Write a personal letter with your child’s picture and say why Ally’s Act needs to pass and become the law! Please send the 1-pager and list of endorsers for Ally’s Act with your letter! (see below attachments)

Helpful information about this piece of legislation can be found on Ear Community’s website under the Ally’s Act Menu tab or here!
Help us pass Ally’s Act, H.R. 2439 and S. 1135!
Thank you!
Melissa Tumblin
Founder – Executive Director
Ear Community
EarCommunity.org

Filed Under: Events, History
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