Acclarent Receives FDA Clearance for New Treatment Alternative for Children Needing Repeat Ear Tubes

acclarent etd treatment
HHTM
December 27, 2023

IRVINE, CALIFORNIA — Acclarent, Inc., part of Johnson & Johnson MedTech and a leader in minimally invasive ear, nose and throat (ENT) technologies, has received clearance from the U.S. Food and Drug Administration (FDA) for use of its Acclarent AERA® Eustachian Tube Balloon Dilation System to treat children ages 8-17 with persistent obstructive Eustachian tube dysfunction (OETD).

This clearance expands access to treatment options for pediatric patients with the ear condition, as the system was previously only indicated for use in adults aged 18 and older.

FDA Expands Clearance to Treat Children

Acclarent is the first company to gain FDA clearance for Eustachian tube balloon dilation in children. Approximately 1.48 million adolescents in the U.S. suffer from OETD, a common condition where the Eustachian tube has difficulty opening, causing fluid buildup and hearing loss, discomfort, pain and/or pressure in the ear. If untreated, OETD in children can lead to delays in learning and development or more serious ear conditions requiring surgery.

Until now, treatment options for children with persistent OETD were limited to tympanostomy tubes, adenoidectomy, and medications to fight infection and inflammation. However, these do not always address the underlying cause. Recurrent ear tube procedures also have potential long-term risks like eardrum perforation, hearing loss and cholesteatoma.

Acclarent AERA System

The Acclarent AERA system was designed specifically for Eustachian tube anatomy with flexibility to reach the source of OETD through a minimally invasive approach without incision of the eardrum. Studies of Eustachian tube balloon dilation in adults have shown significant short and long-term improvement, favorable safety profile and better performance compared to standard medical management.

As Eustachian tube anatomy is similar between children 8 and older and adults, analysis of real-world evidence was done to evaluate the safety and effectiveness of Acclarent AERA in pediatric patients. This data found the system is comparable or superior to tympanostomy tube placement alone for treating persistent OETD.

With this new FDA clearance, the benefits seen in adults can now extend to children 8 years and older. It provides an alternative to recurrent ear tube procedures or medications that may not address the underlying anatomical cause of persistent OETD.

“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. Today’s milestone is an example of how Acclarent collaborates with surgeons to pioneer innovation, driving better outcomes for patients with ENT conditions.”

–Jeff Hopkins, President, Acclarent, Inc.

More information on the AERA Eustachian Tube Balloon Dilation System is available on the company’s website. Acclarent was acquired by Johnson & Johnson MedTech in late 2023, with the transaction expected to close in Q2 2024 pending approvals.

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.

 

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

i. Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii. An ear cholesteatoma is a cyst-like growth behind the eardrum.
iii. Dr. Dennis Poe is a paid consultant to Acclarent, Inc.

 

References:

  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
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  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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