Ear Community visits Seidman Labs at Harvard for Microtia genetics research

Harvard Medical School’s Dr. Jon Seidman and Barbara McDonough with Melissa Tumblin of the Ear Community Organization

Last week on March 25th, 2026, I had the opportunity to meet with our microtia genetics team at Siedman Labs at Harvard Medical School when traveling to Boston! I met with Dr. Jon Seidman and Barbara McDonough, to catch up and discuss our new findings about the increased risk of FOXI3 causing microtia and craniofacial microsomia.

I have known Jon and Barbara for the past 10 years and am incredibly grateful for their passion behind wanting to help find the answers our community is looking for when it comes to what causes Microtia and Craniofacial Microsomia. Visiting them is like visiting with family! Dr. Seidman and Barbara have brilliant minds and are known for their research at Harvard and around the world with Seidman Labs and I am so proud of their passionate work that is at the forefront of genetics research for our microtia community! This is an incredible team we have and I am forever grateful to Dr. Ron Eavey (Vanderbilt) for introducing me to Dr. Seidman! I am also incredibly grateful to Dr. Dan Quiat (Harvard) for his work during our last grant project for microtia and atresia research, including the many researchers who all worked very hard on finding the answers the microtia and atresia community is looking for. While we still have a lot to understand and figure out, the increased risk on FOXI3 is new information and is discussed in our published papers and in the presentation by Dr. Jon Seidman on our website.
Contributing Authors in collaboration with our work include:
Daniel Quiat, Andrew T. Timberlake, Justin J. Curran, Michael L. Cunningham, Barbara McDonough, Maria A. Artunduaga, Steven R. DePalma, Milagros M. Duenas-Roque, Joshua M. Gorham, Jonas A. Gustafson, Usama Hamdan, Anne V. Hing, Paula Hurtado-Villa, Yamileth Nicolau, Gabriel Osorno, Harry Pachajoa, Gloria L. Porras-Hurtado, Lourdes Quintanilla-Dieck, Luis Serrano, Melissa Tumblin, Ignacio Zarante, Daniela V. Luquetti, Roland D. Eavey, Carrie L. Heike, Jonathan G. Seidman and Christine E. Seidman.Genetics research is important to our rare community for so many reasons! As a mother, I can’t tell you how important it is to know about genetic information for our rare cause. This information helps give mothers some peace of mind that they did not do anything during their pregnancy to cause their child’s ear(s) to be missing as well as helping provide some of the missing puzzle pieces when it comes to microtia for our community!

Barbara McDonough – thank you for always taking the time to meet with me and catch up and for always being so welcoming and excited to discuss all things microtia! Thank you for helping change people’s lives with your work and with Drs. Jon and Christine Seidman, everyday!❤👂

More information on genetics research for microtia, along with our published papers, can be found on our Ear Community Organization’s website at:  https://earcommunity.org/genetic-research-on-microtia-and-aural-atresia/

Thank you,
Melissa Tumblin
Ear Community 

 

Ear Community presents at the American Cleft Palate Craniofacial Annual Meeting in Boston

Advocates Melissa Tumblin, Amy Schefer, Dina Zuckerberg, Marly Eugenio and Melissa McGowan present at the Annual ACPA Meeting in Boston during March 2026.

I am grateful for the opportunity to have attended and participated in the American Cleft Palate Craniofacial Association (ACPA) Meeting that was held in Boston last week! Each time I attend this annual meeting, I feel as though it is a second home for me, coming together with existing friends in the craniofacial field and making new friends each time.

While at the ACPA meeting, I had the opportunity to present along side four incredible advocates, sharing about our journey, what we have learned, struggled with and overcome, including the work we are doing to help give back to the community. What an honor it was to present along side these following incredible women advocates: Amy Schefer, Dina Zuckerberg, Marly Eugenio and Melissa McGowen! Each one of us is dedicated to creating change in our communities that will help make things easier for the next family that has a child born with a rare cause. A special thank you to Amy Schefer for submitting our abstract for our panel presenation so each one of our voices could be heard for the communities we serve! Thank you to the ACPA for spotlighting our panel in the captured moments of this year’s meeting and for creating a platform for medical professionals and advocates to share their voices, together! Thank you for everyone’s advocacy!

At ACPA, I embraced connecting with the Vanderbilt team I have worked with over the years with microtia and atresia. I am always happy to see members of our CARE Research team who have worked very hard on collaborative research for our microtia and atresia community over the past five years together. It is always wonderful to see Ear Community friends from Nemours Children’s, Seattle Children’s, Nationwide Kids, and Old Dominion U and of course everyone at the ACPA! THANK YOU to the ACPA for creating a much needed platform and a place for collaboration where medical professionals and advocates can come together to share our voices and work! Thank you for everyone’s advocacy!

It is always wonderful to be brought together throughout the craniofacial world as an advocate! Advocates come in all shapes and sizes and what we offer is often priceless!

I always look forward to seeing the incredible advocates in our community that include patients themselves as well as some pretty incredible organizations that help those in need, creating a home for so many! Whether it is a mother’s love for her child or a child who has overcome struggles along their journey, but is now advocating for others just like them – we all have a common goal of providing help, support, community and compassion that will ultimately lead to helping make someone else’s life easier or sharing the journey of hope and learning from each other.

Here’s to the advocates at ACPA and in the combined communities who make incredible change and provide the hope and help when in need! Advocates also include medical professionals and representatives who help market medical technology that can help make our lives better and along side researchers, writers and volunteers. Thank you for everyone’s advocacy – always! Thank you to the ACPA for always creating such a professional meeting for the craniofacial field and community! Executive Director Adam Levy always does such a great job for the ACPA!

The following are just some of the many friends and faces that I always appreciate seeing at meetings like ACPA! Choose kind! ❤👂

Thank you,
Melissa Tumblin
Founder – Executive Director
Ear Community

Microtia and Atresia picnics offered through the Ear Community Organization for summer of 2026

Ear Community’s picnics are coming up this summer and we look forward to seeing so many of our beautiful microtia and atresia families come together on one of our special days!

Our Ear Community picnics are priceless and FREE! For the past 16 years, our Ear Community Organization has been bringing our microtia and atresia families together so the kids can play and maybe make a new friend, parents can share their journeys and so no one ever feels alone with microtia and atresia!

* Please RSVP to Lauren at LaurenEarCommunity@gmail.com

Summer of 2026 Picnic Line up:
Brookline, MA – Saturday, June 6th
San Diego, CA – Saturday, June 13th
Jeffersonville, IN – Saturday, June 27th
San Antonio, TX – Saturday, July 11th
Broomfield, CO – Saturday, July 25th

Join us for lunch and a day of fun with face painters, balloon artists and magicians! We’ll learn about the latest in bone anchored hearing devices thanks to Cochlear Americas, MED-EL USA and Oticon Medical! We’ll also have our microtia glasses at our picnics thanks to Ear Community’s Pax’s Eyewear Fund and our friend, James Hermsen of SuhHermsen Adaptive Eyewear Solutions who designs these glasses for microtia kids along side Dr. Donny Suh! We’ll have medical professionals joining us so everyone can find the answers they are looking for including Su-Por educating on the porous polyethylene implant used in auricular reconstruction ! We’ll also have some anaplastologists joining us as well to help educate us about prosthetic ears! It will be a wonderful day to come together and learn about your options when it comes to microtia and atresia!

* Our Colorado Ear Community picnic this year is in collaboration with Dr. Sheryl Lewin! Please click on the following link for conference registration details with the Earicle’s Conference!

A HUGE THANK YOU to our Ear Community picnic hosts for bringing their community and our families together at this year’s events!
The Furze Family
The Smyth Family
The McClellan Family
The Quesada Family

The Parcher Family

A special thank you to all of our Ear Community Sponsors for helping make our special days possible for our community and for helping support the good work our Ear Community Organization does for our community!
See everyone soon!
Ear Community 👂❤️

Oticon Medical Undergoes Successful Ownership Transition Following Acquisition by Impilo


Gothenburg
31 March 2026

On Tuesday, March 31st, 2026, Oticon Medical is pleased to share that Demant has successfully finalized the agreement with Impilo, transferring ownership of Oticon Medical to Impilo and marking the beginning of a new strategic chapter for the organization.

The acquisition positions Oticon Medical to further accelerate innovation, strengthen its market presence, and continue delivering life changing bone anchored hearing solutions (BAHS) to patients worldwide.

The agreement includes a long-term collaboration between Oticon Medical, Impilo, and Demant, ensuring continuity and advancing joint development of next generation Ponto and Sentio sound processors, alongside continued manufacturing, and supply partnerships.

For customers, partners, and patients, the transition brings full operational continuity—daily operations, local sales structures, and customer support remain unchanged.

“Impilo shares our values and vision, and as our new owner, brings the investment and strategic focus needed to further strengthen our position in the BAHS market,” says René Govaerts, President & General Manager, Oticon Medical. “We are confident this partnership will help us continue delivering exceptional solutions and support.”

“We are delighted to partner with management on the acquisition of Oticon Medical to accelerate growth, drive innovation, and further improve patient outcomes. The company has established itself as a leading player in the attractive and underpenetrated global BAHS market and has strengthened its position with the recently launched transcutaneous product, Sentio, which has already demonstrated impressive results. We are deeply impressed by the management team’s expertise, their ability to deliver outstanding patient support, and their unwavering commitment to improving patient outcomes. We look forward to our partnership with management and to the journey ahead, advancing the development of cutting-edge BAHS solutions that will further enhance the lives of patients.” says Magnus Edlund, Partner at Impilo.

Oticon Medical remains dedicated to delivering solutions that elevate hearing and enrich lives. With a clear vision ahead and the support of its new owner, the company is poised to advance boldly into the next era of growth and innovation.


 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.

About Impilo

Impilo is a Nordic investment company focused solely on investments in lower-mid-market Nordic healthcare companies. It seeks majority buyouts of privately held companies across the pharmaceuticals, MedTech, specialist pharma services and other healthcare & related services industries. Target companies must contribute to the positive and sustainable development of the markets in which they operate, as well as have a credible path to becoming a market leader in their respective niche. Impilo has a well-diversified portfolio of healthcare investments and manages approximately €2 billion of capital from leading international investors.

Medical Professionals take to Capitol Hill to advocate for support of Ally’s Act, H.R. 4606 and S. 3400 honoring World Hearing Day

Melissa and Ally Tumblin World Hearing Day ASHAMarch 3rd was World Hearing Day!

This year’s theme for World Hearing Day is “From Communities to Classrooms – Hearing Care for Every Child.”World Hearing Day is an annual day to raise global awareness on preventing deafness and promoting proper ear and hearing care. Organized by the  World Health Organization (WHO), this event highlights ear care as a critical public health issue. The 2026 theme, “From Communities to Classrooms: Hearing Care for All Children,” focuses on early identification and prevention of hearing loss in children.

Over the last two weeks, members of AAO-HNS Government Affairs and American Academy of Otolaryngology—Head and Neck Surgery, advocated on Capitol Hill in Washington DC during Congressional Advocacy Day, advocating for legislation that would help improve hearing healthcare for children, like Ally Tumblin, and for legislation like Ally’s Act, H.R. 4606 and S. 3400 this week in DC!

Standing on the steps of the U.S. Capitol, these physicians represent more than their practices. They represent the patients and families who rely on access to high-quality ENT care every day. By meeting with lawmakers, they are sharing real patient stories and advocating for policies that protect access to care, advance hearing health equity, and strengthen the future of our healthcare system. Thank you to the dedicated members and medical professionals for lending their expertise and their voices on behalf of patients and thank you for advocating for support of Ally’s Act, H.R. 4606 and S. 3400! Your support and advocacy for this bill alone would help give hundreds of thousands of children and adults better quality lives with better access to bone anchored hearing systems and cochlear implants when it comes to private insurance coverage for these hearing devices! Thank you for your advocacy! A special thank you to Dr. Amelia Drake of Chapel Hill (ENT), Dr. Rahul Shah (CEO of the American Academy of Otolaryngology – Head and Neck Surgery (AAOHNS) and Harry DeCabo (Director of Advocacy AAOHNS) for your support of Ally’s Act!

ASHA – the American Speech-Language-Hearing Association also advocated for Ally’s Act on Capitol Hill in support of World Hearing Day! ASHA, along with speech therapists, advocated for how important hearing health care is and how important it is for children and adults to be able to benefit from hearing device technology, newborn hearing screenings and therapy services that help prevent the risk of speech delays and help improve the quality of life for those individuals who have hearing loss. A special thank you to Josh Krantz, Director of Federal Affairs at ASHA and Jerry White, Director of Federal and Political Affairs, for their advocacy in fighting for legislation that is needed, like Ally’s Act, H.R. 4606 and S. 3400. In addition to these congressional advocacy days on The Hill with meetings, many within the community made calls and sent emails to their Congressmen and Senators, asking them to cosponsor Ally’s Act, sharing their stories and explaining why this bill is needed and has been needed for decades. Many requested that their Representatives help with getting a hearing for our bill!
Video of Melissa and Ally Tumblin by ASHA

Passage of Ally’s Act would allow the children and adults within our community to be able to thrive in their communities and live a better quality of life. After all, hearing is essential to everyday life, allowing our loved ones to be able to contribute to society and be able to provide for themselves. Bone Anchored Hearing Device Systems and Cochlear Implants give children and adults their lives back! When these hearing device systems are the only hearing devices that these individuals can benefit from, it is unacceptable for private insurers to determine who gets to hear and who does not when these devices are medically necessary and needed. Ally’s Act would close the loop hole for private insurers to deny coverage for BAHS and CI hearing device implant systems for both children and adults from birth to age 64. These hearing device systems are already covered by Medicaid and Medicare.

Thank you again to everyone who is advocating for Ally’s Act, H.R. 4606 and S. 3400 to pass!
Melissa Tumblin
Ear Community

#entadvocacy #aaohnsadvocacy #patientaccess #otolaryngology #allysact #boneanchoredhearingdevices #cochlearimplant #EarCommunity

Ear Community welcomes new Program Director

Lauren and Paxton Hoyal

Welcome to our newest Ear Community staff member! Meet Lauren Hoyal, Ear Community’s new Program Director!

Lauren is responsible for managing our organization’s events, advocacy outreach for hearing device donations and fundraising. Lauren and her family found Ear Community after her youngest son, Paxton, was born with microtia and atresia. The Hoyal Family has since then been involved with our organization as a picnic host family, advocating for Ally’s Act and have fundraised for our organization.

Lauren earned her Masters in Elementary Education from Valdosta State University where she taught 1st grade for three years before deciding to stay home with her beautiful daughter, Vada. Lauren also serves on the Thomaston Upson Arts Council Board of Directors where she is the Children’s Art Chair. She is also the Director of the Thomaston First Methodist Church Preschool. Lauren’s husband, Perry, is a firefighter and flight paramedic who saves lives everyday!

I am grateful for Lauren and Perry and their beautiful family! Lauren has become an incredible advocate for our community and a wonderful friend to me! Thank you for helping me serve our community through the work of our Ear Community Organization, Lauren!

Welcome aboard! I am lucky to have you!
Melissa Tumblin
Founder – Executive Director
EarCommunity.org

The Ear Community welcomes newest Board Member, Dr. Kripa Raman!

The Ear Community announces it’s newest Board of Directors Member, Dr. Kripa Raman.

“We would like to welcome Dr. Kripa Raman to Ear Community’s Board of Directors, says Melissa Tumblin, Founder and Executive Director of the Ear Community Organization. I have had the honor of knowing Kripa over the past four years. She has already been doing incredible work in our community, helping make connections and advocate for our microtia and atresia families in the Ontario area and all over Canada! I am grateful for her help and her shared passion for helping our children as well as her dedication to our microtia and atresia community!”

Kripa is a mother to two boys in Ontario, Canada. Her oldest son, Jahnu, was born with unilateral microtia and atresia of his left ear. Currently he is unaided and thriving! Kripa has a PhD in Molecular Biology and Genetics from McMaster University. She works in pharmaceuticals leading health economic assessments to secure funding for new therapeutics. Her advanced scientific and healthcare background has been very helpful when navigating the Canadian health care system and advocating for her son. When she is not entertaining the boys, she is planning their next family trip, listening to an audiobook, or trying a new recipe.

Kripa has been the organizer behind the Ontario Ear Community picnic in both 2023 and 2025. For her, these events are all about connection. “Given the rarity of microtia, I felt quite lonely after the initial diagnosis. Balancing new motherhood with those
unknowns was a source of anxiety, but finding the Ear Community online gave me the connection I needed. The picnics are amazing since for many kids, it’s the first time they’ve ever seen little ears like their own. I want my son to know he belongs to a community, and seeing him meet others just like him is so special.”

Board Members for the Ear Community Organization consist of members of the community that include individuals who were born with microtia and aural atresia, family members and medical professionals. “It is important for our community to be informed of all options for microtia and aural atresia, says Melissa Tumblin, Founder of Ear Community. It is also important to hear from parents, like Kripa, and to see how her family journey with microtia and atresia is going. It is incredibly helpful for children and adults and their families to see what others in the community are doing regarding the decisions they make along the way on their journey. This is where advocates can play a big part in helping others understand decisions and choices and also to help give some perspective when talking with others in the same situation”.

“We are looking forward to Kripa joining our board,” said Ear Community Founder, Melissa Tumblin! Our community is made up of amazing advocates and role models and Kripa is already an amazing advocate in our community! We are honored to have her serve on our Board as she continues helping families and community members in Canada who have microtia and aural atresia!”
Melissa Tumblin
Founder – Executive Director
Ear Community

New Bill: Senator John R. Curtis introduces S. 3400: Ally’s Act


By: Quiver LegislationRadar
Dec. 9, 2025 

We have received text from S. 3400: Ally’s Act. This bill was received on 2025-12-09, and currently has 4 cosponsors.

Here is a short summary of the bill:

This bill, known as Ally’s Act, aims to enhance health insurance coverage related to hearing devices and systems by making specific requirements for group health plans and health insurance issuers. It seeks to ensure that individuals with hearing loss receive adequate support and services necessary for their auditory needs.

Key Provisions of the Bill

1. Coverage Requirements

The bill mandates that group health plans and health insurance issuers provide coverage for a variety of services and items related to auditory implant devices, including:

  • Auditory implant devices (e.g., cochlear implants) and external sound processors.
  • Maintenance of these devices.
  • Upgrades or replacements of devices every five years.
  • Adhesive adapters and softband headbands.
  • Repairs of devices.
  • A comprehensive hearing assessment.
  • A preoperative medical assessment.
  • Surgery related to the implantation of these devices.
  • Postoperative medical visits and audiological visits for fitting and activation.
  • Aural rehabilitation and treatment services as deemed necessary.

2. Financial Requirements and Treatment Limitations

The bill includes provisions to ensure that financial requirements and treatment limitations for the mandated services and items are not more restrictive than those applied to other medical and surgical benefits governed by the same health plans. Specifically:

  • The cost-sharing requirements for these auditory services cannot be more onerous than those for other covered medical benefits.
  • There must not be treatment limitations that are more restrictive than those that apply to other medical benefits covered by the plan.

3. Medical Necessity Review

Health plans are prohibited from denying or limiting coverage for any of the items or services identified in the bill that have been deemed medically necessary by a physician or qualified audiologist. This ensures that if a healthcare provider recommends a specific service or device, it will be covered under the health insurance plan.

4. Definition of Qualifying Individual

A ‘qualifying individual’ is defined in the bill as someone who has been determined by a physician or qualified audiologist to require an auditory implant device or external sound processor, based on criteria including degree of hearing loss.

Legislative Process

This bill has been introduced in the Senate and referred to the Committee on Health, Education, Labor, and Pensions for further consideration. It is set to take effect for plan years beginning on or after January 1, 2026, if passed.

Relevant Companies

  • WSO (Watsco, Inc.): As a leading distributor of HVAC equipment, Watsco could experience changes in market demand for hearing services due to this bill impacting health coverage.
  • CSCO (Cisco Systems, Inc.): Involved in various technologies, including those relevant to audiology and telehealth, which might see increased utilization.
  • ADBE (Adobe Inc.): As a provider of software solutions perhaps used in healthcare contexts, they might experience indirect impacts depending on the nature of compliance requirements with new regulations.

 Link to press release.

Gael Receives the Gift of Hearing Thanks to Cochlear Americas, the Evans and the Gross Family and the Ear Community Organization

Meet Gael! Gael is eight years old and was born with unilateral microtia and aural atresia of his right ear. When Gael’s family recently moved to North Carolina, his mom, Alba, started noticing that he was not hearing everything. In between moments of him looking a little lost in conversation to questioning what she just said, she realized he was struggling with his hearing! Thankfully, because Gael is old enough to communicate,  he was able to speak up about his hearing loss along with his mom paying attention to what Gael was missing out on and realizing what he needed. While trying out a loaner Baha (bone anchored hearing aid) through his audiologist at the UNC Medical Center Pediatric Audiology Department, both Gael and his mom realized how much better he could hear while wearing the Baha! Moving forward, when inquiring about obtaining a Baha of his own, Gael’s family realized they could not afford the cost of a bone anchored hearing device that could help him hear better. That’s when the audiology team over at UNC Health came together to help Gael find a way to hear!

Dr. Molly Widney of UNC Health, along with Ellie McIntosh – Audiology Extern at UNC Health and Dr. Shannon Culbertson – also of UNC Health and a Board Member for the Ear Community Organization, knew there was a way to help Gael hear! Together, they submitted an application to help Gael obtain a Cochlear Americas Baha 7 through the Ear Community Organization! In addition, Julie and Danny Evans wanted to help give back to our community when there was an opportunity for a child who needed help with a hearing device. I remember having a conversation with Julie at our Ear Community/Vanderbilt event in Nashville this summer about what happens when a child cannot afford a hearing device or is denied coverage by their insurance provider and I sadly explained that they often have to go without. Julie and Danny’s son, Asher, was born with bilateral microtia and atresia and even though their son has two hearing devices that help him hear, they couldn’t imagine another child having to do without. On National Microtia and Atresia Awareness Day, the Evans Family made a donation to our organization that would help cover Gael’s fitting and programming fee for his newly donated Baha 7! Together, Gael’s audiology team, Cochlear Americas and the Evans Family were able to all help together and give back!

On Tuesday, December 16th, 2025, Gael was able to receive the gift of hearing with his NEW Baha 7 thanks to the help of Cochlear Americas, his audiology team working together and the donation to our organization thanks to the Evans Family! In addition to receiving a the donated Baha 7, the Ear Community Organization also helped cover some of the cost of Gael’s fitting and programming! Thanks to programs like Pax’s Ear Fund that our organization has in place, to ensure that bone anchored hearing devices can still be programmed even if a family cannot afford the fitting fee or in the event insurance denies coverage for this service through audiology. Recipients can still receive the gift of hearing!

When a child receives the gift of hearing, it truly is a miracle. Otherwise, children and adults end up having to do without, continuing to struggle to hear and missing out on conversations like Gael was. Hearing loss is also a safety issue when someone cannot hear well. Just in time for Christmas, Gael was able to receive the gift of hearing, which was such a needed miracle that will allow him to hear better in the school classroom and thrive in his community along with no more parts of conversations missed!

Without helpful resources and organizations that are here to help, Gael might still be struggling to hear if it weren’t for the joint effort of his mom and his audiology team at UNC Health, reaching out to our Ear Community through Pax’s Ear Fund and for the help of the Evans’ family wanting to sponsor a child like their son, Asher – another child is able to hear!  It just takes one person to search for a way to help or to know what helpful resources might exist to help others. Thank you so much to Dr. Molly Widney, Ellie McIntosh and Dr. Shannon Culbertson for knowing where to find help for Gael! Thank you to Keesha Pfeiffer, Manager Health Policy Strategy and Advocacy at Cochlear Americas, for helping Gael receive a NEW Baha 7 just in time for Christmas and to Cochlear Americas for partnering with nonprofit organizations like the Ear Community to help give back to the microtia and atresia community! “Cochlear is the global leader in implantable hearing solutions, and has provided more than 750,000 implantable devices – more than any other company – helping people of all ages to hear and connect with life’s opportunities.” Since 2011, Cochlear Americas is a proud Platinum Sponsor to the Ear Community Organization, helping the microtia and atresia community. Thank you Cochlear Americas for being a leading company behind the hearing device technology that helps children like Gael benefit when it comes to restoring hearing loss! Children and adults with microtia and atresia can only benefit from the use of a bone conduction hearing device because of specific related conductive hearing loss. Thank you to the Evans Family for being a part of our beautiful community with their son and for wanting to help give back to another child in need who has microtia and atresia! A special thank you to the William, Jeff and Jennifer Gross Family Foundation and to Peter Stengaard for funding Pax’s Ear Fund to help give the gift of hearing when fittings and programmings are not covered by insurance or simply cannot be paid for. Pax’s Ear Fund was established because of a sweet little boy named Pax who believes in helping other children in our community just like him! This year, Pax’s Ear Fund was able to help nine children and adults receive the gift of hearing through our Ear Community Organization! Thank you so much for all of this incredible support to our Ear Community and to the microtia and atresia community!

We are so happy for Gael to be hearing his best and we are grateful for so many reaching out to help him receive the gift of hearing during the holidays this year!
Thank you to everyone who helped make this possible for Gael! Below are some images of Gael receiving his NEW Baha 7 and enjoying his new koala bear friend and also of Julie Evans and her son, Asher. Thank you for giving back!
Melissa Tumblin
Ear Community

MED-EL Becomes First to Receive FDA Approval for Cochlear Implantation at Seven Months

 


December 4, 2025

DURHAM, NORTH CAROLINA – MED-EL USA announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for MED-EL cochlear implants for children seven months and older with bilateral sensorineural hearing loss (SNHL). This approval makes MED-EL’s cochlear implant system the first and only FDA-approved option for infants this young, enabling earlier access to sound and crucial stages of speech and language development.

“Giving infants the opportunity to hear early in life is critical to maximizing the development of hearing and spoken language. It is extremely gratifying to have led this clinical trial demonstrating the safety and effectiveness of the latest implant technology for children as young as seven months. My hope is this will mean more children will experience the gift of sound soon after birth,” said Nancy M. Young, M.D., Lillian S. Wells Professor of Pediatric Otolaryngology and Medical Director of the Cochlear Implant Program at Ann & Robert H. Lurie Children’s Hospital of Chicago.

The expanded FDA indication also broadens audiologic and speech criteria for children aged 12 months and older, providing the widest pediatric eligibility of any hearing implant manufacturer.

“Many children with significant hearing loss use hearing aids but cannot hear all the sounds essential for understanding spoken language. They must work so much harder than their hearing peers. Expanding the eligibility of these children for cochlear implantation is so important to improving their hearing, language, literacy, and quality of life” 

–Nancy M. Young, M.D.

“This is an incredible step forward for families with young children with hearing loss,” said John Sparacio, President and CEO of MED-EL USA. “Giving children access to sound as early as possible can make a world of difference for their future. We are committed to giving every child the best possible start in life through our closest to natural hearing philosophy paired with our advancements in safety and technology.”

Key Data Highlights

  • An FDA study in two groups of children found MED-EL cochlear implants to be safe and effective for ages seven to 71 months with bilateral SNHL who do not receive sufficient benefit from hearing aids.
  • Among 123 children, 110 showed clinical success within the first year, including 81% in one study group and 88% in the other.
  • Major complication rates were low in both groups, and children implanted under 12 months did not experience higher complication rates than older children.
  • A post-approval study will collect additional data from children implanted between seven months and 17 years, 11 months who meet the new labeling criteria.

For more information about MED-EL cochlear implants, visit www.medel.com.

About MED-EL

Medical Electronics (MED-EL) is a global leader in implantable hearing solutions, driven by a mission to overcome hearing loss as a barrier to communication and quality of life. Founded in Austria by Ingeborg and Erwin Hochmair—whose early research led to the world’s first micro-electronic multi-channel cochlear implant in 1977—MED-EL has grown to more than 3,000 employees representing around 90 nationalities across 30 locations worldwide.

Today, MED-EL offers the broadest portfolio of implantable and non-implantable hearing solutions, supporting people in 139 countries. Its technologies include cochlear and middle ear implant systems, electric acoustic stimulation systems, and both surgical and non-surgical bone conduction devices. Learn more at www.medel.com.

 

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