Hearing management

19 September 2016

FDA approves balloon device to clear Eustachian tube

The American FDA approved a device designed to treat Eustachian tube dysfunction (ETD), a condition that leads to sensations of pain, pressure or clogging inside the ear.

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A small device inflated inside the tube that helps regulate pressure inside the ear has been approved by the US Food and Drug Administration.

Reduced hearing

The Aera Eustachian Tube Balloon Dilation System is designed to treat Eustachian tube dysfunction (ETD), a condition that leads to sensations of pain, pressure or clogging inside the ear.

The Eustachian tube is a valve-like apparatus that connects the middle ear to the back of the throat. It's normally filled with air and helps equalise pressure inside the ear with the surrounding environment, the FDA explained in a news release.

Read: Nasal balloon a possible solution for 'glue ear'

When the tube doesn't function properly, it can lead to symptoms including reduced hearing, frequent ear infections and ringing in the ears.

The new device is inserted through the nose into the Eustachian tube, where a small balloon is inflated and creates a path for mucus and air. The balloon is then deflated and removed, the agency said.

Side effects

In clinical trials, 52 percent of participants given the device had normal Eustachian tube test results six weeks after the procedure, compared with 14 percent who were treated with a conventional nasal spray.

Read: SEE: 7 noises that can cause permanent hearing loss

The most common side effects included Eustachian tube puncture, minor bleeding and worsening ETD.

The device shouldn't be used by people under age 22, among those whose Eustachian tube is always open, or among people with a condition in which the carotid artery protrudes through a gap in the bone that surrounds the Eustachian tube.

The device is produced by Irvine, Calif.-based Acclarent Inc.

Read more:

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Symptoms of hearing loss

Types of hearing loss

 

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AuD degree obtained in 2013 at AT Still University Health Science Depart-ment, Arizona. Masters in Communication Pathology at the University of Pretoria, 2003. Remedial Teaching Diploma at Rand University, 1996. Degree in Speech-Language Pathology and Audiology at the University of Pretoria, 1993. Owner of a private practice in Pretoria since 1999. Educating the community regarding early identification of hearing problems and screening of new-borns. Providing assistance and services at retirement homes. Part-time lecturer at the University of Pretoria and the University of Limpopo. External examiner at the University of Pretoria and the University of Limpopo. Presenter at conferences and seminars.

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