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  • FDA Approved Balloon Device For Treating Persistent Eustachian Tube Dysfunction Now Offered By Three Rivers Health And Dr. Doug Ready

    January 29, 2017

    Three Rivers Health just announced that Dr. Doug Ready, West Michigan Ear, Nose & Throat specialist, will offer the first-ever FDA approved treatment or patients suffering with Eustachian Tube Dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. Three Rivers Health will be one of the first facilities to offer this procedure in Southwest Michigan.

    “The Aera Eustachian Tube Balloon Dilation System is a promising new treatment option for patients with ETD symptoms. The goal is to restore function to this important part of the middle ear to bring relief from the pain, sensation or discomfort associated with ETD,” said Chief Executive Officer William Russell.

    Acclarent, part of the Johnson & Johnson family of companies, announced on September 16, 2016, the FDA clearance of the ACCLARENT AERATM Eustachian Tube Balloon Dilation System, the first balloon dilation system designed for Eustachian Tube Dilation in the United States. ACCLARENT AERATM is designed to provide ENTs the ability to adapt to sensitive Eustachian tube anatomy with minimal risk and little trauma to the tissue.

    According to the FDA, with the Aera system, a doctor uses a catheter to insert a small balloon through the patient’s nose and into the Eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through the Eustachian tube, which may help restore proper function. After the Eustachian tube is dilated, a doctor deflates and removes the balloon.

    ETD is a condition affecting approximately 1 percent of adults in the U.S. and is often marked by ear pain, pressure and dulled hearing. The release of ACCLARENT AERATM provides surgeons and patients with an important minimally invasive option to help address the source of persistent ETD. If left untreated, ETD can lead to chronic ear symptoms or serious conditions including middle ear effusion, infections and related long-term complications.

    ACCLARENT AERATM clinical trial evidence demonstrated a technical success rate of 99.7% Eustachian tubes dilated. Additionally, there were zero serious device- or procedure-related adverse events reported during the length of study.