Acclarent receives first and only FDA clearance for new treatment alternative for children needing repeat ear tubes

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IRVINE, California , December 20, 2023 (press release) –

Expanded indication for AERA® Eustachian Tube Balloon Dilation System broadens access to meet the needs of some pediatric patients in the U.S.


Acclarent, Inc., part of Johnson & Johnson MedTech,i and a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, has received clearance from the U.S. Food and Drug Administration (FDA) for the Acclarent AERA® Eustachian Tube Balloon Dilation System in the treatment of children, ages 8-17, with persistent obstructive Eustachian tube dysfunction (OETD). Today’s news expands access to treatment options for pediatric patients with OETD, previously only indicated for adults. Acclarent is the first and only company to receive FDA clearance for Eustachian tube balloon dilation in children.

Approximately 1.48 million adolescents in the US suffer from OETD,1 a common ear condition where the Eustachian tube has difficulty opening. This causes a buildup of fluid in the ear, leading to hearing loss, discomfort, pain and/or pressure. If left untreated, OETD in children may cause delays in learning and development, or more serious ear conditions requiring invasive surgery.2

Until now, treatment options for children with persistent OETD were limited to tympanostomy (ear) tubes, adenoidectomy (removal of the adenoids) and oral therapies to fight infection and inflammation. However, these options do not always treat the source of the problem. In addition, recurrent ear tube procedures may be associated with long-term complications, such as ear drum perforation, conductive hearing loss or cholesteatoma.ii,3,4,5 With Acclarent’s expanded indication of the AERA® Eustachian Tube Balloon Dilation System, parents now have access to an effective alternative to treat their children with persistent ear symptoms.

“In cases where symptoms continue and additional procedures are required, Eustachian tube balloon dilation could treat the underlying cause of persistent OETD. With this FDA clearance, physicians will be able to offer their pediatric patients an effective alternative that provides enduring relief, reducing stress and concerns for parents,” said Dennis Poe, M.D., Ph.D., Professor of Otolaryngology–Head and Neck Surgery, Harvard Medical School, and Associate in the Department of Otolaryngology and Communication Enhancement at Boston Children's Hospital.iii

Acclarent AERA® was specifically designed for the Eustachian tube anatomy with flexibility to reach the source of the problem in a minimally invasive way without incision in the ear drum. A robust and growing body of Eustachian tube balloon dilation evidence in adults has shown significant short-term improvement, long-term durability, favorable safety profile and superior performance compared to medical management.6,7 The Eustachian tube anatomy of children aged 8 and older closely matches that of adult patients.8 Real-world evidence was analyzed to evaluate the safety and effectiveness of Acclarent AERA® in patients aged 8-17 with OETD, which supports that Eustachian tube balloon dilation is comparable, if not superior, to tympanostomy tube placement alone.9 With the FDA clearance of Acclarent AERA®, the established benefits seen in studies for adults will now be accessible to children aged 8 and above.8,10,11,12

“The expanded indication of the Acclarent AERA® Eustachian Tube Balloon Dilation System is a transformational moment for families and children suffering with chronic ear issues,” said Jeff Hopkins, President, Acclarent, Inc. “Today’s milestone is an example of how Acclarent collaborates with surgeons to pioneer innovation, driving better outcomes for patients with ENT conditions.”

For more information, visit the AERA® Eustachian Tube Balloon Dilation System page on our website.

Media contact:
Diane Pressman
Dpressm1@its.jnj.com

About Acclarent AERA® Eustachian Tube Ballon Dilation System
The Acclarent AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

For patients ages 8-17 years, the Acclarent AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

About Acclarent
Acclarent, Inc., part of Johnson & Johnson MedTech, is located in Irvine, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat. For more than a decade, Acclarent has led the field in delivering innovative technologies to ENT surgeons. For more information, visit acclarent.com  In December 2023, Johnson & Johnson entered into an agreement with Integra LifeSciences to acquire Acclarent. The transaction is expected to close by Q2 2024, subject to customary closing conditions and regulatory approvals.

About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

Important Safety Information
Acclarent Technology is intended for use by or under the direction of a physician. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and expertise.

Cautions Concerning Forward-Looking Statements 
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding AERA® Eustachian Tube Balloon Dilation System Use in Children Ages 8 Years and Older. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Acclarent, Inc., any of the other Johnson & Johnson MedTech companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Acclarent, Inc., Johnson & Johnson MedTech nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

© Johnson & Johnson Acclarent, Inc. 2023. All rights reserved. US_ACC_AENT_302032

  1. Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
  2. An ear cholesteatoma is a cyst-like growth behind the eardrum.
  3. Dr. Dennis Poe is a paid consultant to Acclarent, Inc.
  1. Kim AS, Betz JF, Goman AM, et al. Prevalence and Population Estimates of Obstructive Eustachian Tube Dysfunction in US Adolescents. JAMA Otolaryngology–Head and Neck Surgery. 2020;146(8):763-765. doi:10.1001/jamaoto.2020.0962
  2. Aboueisha MA, Attia AS, McCoul ED, et al. Efficacy and safety of balloon dilation of eustachian tube in children: Systematic review and meta-analysis. International Journal of Pediatric Otorhinolaryngology. 2022; 154. doi:10.1016/j.ijporl.2022.111048
  3. Adil E, Poe D. What is the full range of medical and surgical treatments available for patients with Eustachian tube dysfunction? Current Opinion in Otolaryngology & Head and Neck Surgery. 2014;22(1): 8-15. doi:10.1097/MOO.0000000000000020
  4. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngology–Head and Neck Surgery. 2001;124(4):374-380. doi:10.1067/mhn.2001.113941
  5. Ho S, Kay DJ (2016) Tympanostomy Tube Selection: A Review of the Evidence. International Journal of Head Neck Surgery. 2016;7(1):17-22. doi:10.5005/jp-journals-10001-1259
  6. Huisman JM, Froukje JV, Stegeman I, et al. Treatment of Eustachian tube dysfunction with balloon dilation: A systematic review. Laryngoscope. 2018;128(1): 237-247. doi: 10.1002/lary.26800
  7. Froehlich MH, Phong TL, Nguyen SA, et al. Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes. Otolaryngol Head Neck Surg. 2020;163(5):870-882. doi: 10.1177/0194599820924322
  8. Magro I, Pastel D, Hilton J, et al. Developmental Anatomy of the Eustachian Tube: Implications for Balloon Dilation. Otolaryngology–Head and Neck Surgery. 2021;165(6):862–867. doi:10.1177/0194599821994817
  9. Acclarent AERA® Eustachian Tube Balloon Dilation System Traditional 510(k) K230742
  10. Takasaki, K. et al. Measurement of angle and length of the eustachian tube on computed tomography using the multiplanar reconstruction technique. Laryngoscope. 2007;117(7):1251–1254. doi:10.1097/MLG.0b013e318058a09f
  11. Yu Y, Geffen B, McCrary H, et al. Measurements of The Pediatric Cartilaginous Eustachian Tube: Implications for Balloon Dilation. Laryngoscope. 2023;133(2):396–402. doi: 10.1002/lary.30113
  12. Janzen-Senn I, Schuon RA, Tavassol F, et al. Dimensions and position of the Eustachian tube in Humans. PLoS One. 2020;15(5). doi:10.1371/journal.pone.0232655

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