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Hearing management

Updated 29 November 2017

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:

What is hearing loss?

Symptoms of hearing loss

Types of hearing loss

 

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Hearing Expert

Dr Kara Hoffman graduated from UCT in 2004, thereafter she completed her year of community service in Durban. In 2010 she completed her Masters Degree in Paediatric Aural Rehabilitation from UKZN. In 2016, she became a Doctor of Audiology through the University of Arizona (ATSU). Dr Hoffman and her partner Lauren Thompson opened a fully diagnostic audiology practice called Thompson & Hoffman Audiology Inc. In 2011 with world-class technology and equipment to be able to offer the broad public all hearing-related services including hearing testing for adults and babies, vestibular (balance) assessments and rehabilitation, industrial audiology, hearing devices, central auditory processing assessments for school-aged children, school screening, neonatal hearing screening programmes at Alberlito and Parklands Hospital, cochlear implants and other implantable devices, medicolegal assessments and advanced electroacoustic assessments of hearing. Thompson and Hoffman Audiology Inc. are based at Alberlito Hospital in Ballito, St Augustines Hospital in Durban and at 345 Essenwood Road, Musgrave. The practices are all wheelchair friendly. There are three audiologists that practice from Thompson & Hoffman – including Dr Kara Hoffman, Lauren Thompson & Minette Lister. The practice boasts professional, highly qualified, and extensive diagnostic services where all your hearing healthcare needs can be met. The additional licensing in vestibular assessment and rehabilitation, paediatric rehabilitation and cochlear implantation places this practice in one of the top specialist audiological positions in South Africa, with a wealth of experience in all clinical areas of audiology and is a very well respected and sought-after practice.

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