2 The procedure
2.1.1 The Eustachian tube is a narrow tube that connects the middle ear with the back of the nose. If it is blocked (does not open physiologically), symptoms such as muffled hearing, pain, a feeling of fullness in the ear, tinnitus or dizziness may occur. The Eustachian tube typically becomes blocked following the onset of an upper respiratory tract infection or allergic rhinitis. It is usually a temporary problem that resolves spontaneously, but sometimes symptoms persist and treatment is necessary. Long-term Eustachian tube dysfunction is associated with damage to the eardrum and middle-ear transformer mechanism.
2.1.2 Medical treatments include decongestants, oral and nasal steroids and antihistamines. Autoinflation is a technique whereby the Eustachian tube is reopened by raising the pressure in the nose. This can be achieved in several ways, including forced exhalation against a closed mouth and nose.
2.1.3 If troublesome Eustachian tube dysfunction persists, a tympanostomy tube (also known as a ventilation tube or grommet) may be inserted through a small incision: repeated tube insertions may be required. Special long-acting tubes are sometimes used but these are subject to crusting, infection, obstruction and permanent tympanic membrane perforation.
2.2.1 Balloon dilatation of the Eustachian tube is used in adults with the aim of widening the Eustachian tube and improving its function.
2.2.2 Preoperative tubomanometry is initially used to quantify the degree of Eustachian tube dysfunction. Balloon dilatation of the Eustachian tube is usually performed with the patient under general anaesthesia. A balloon catheter is introduced into the Eustachian tube via the nose, under transnasal endoscopic vision. Once the balloon is correctly positioned within the Eustachian tube, it is filled with saline up to a pressure of about 10 bars. Pressure is maintained for approximately 2 minutes. The balloon is then emptied and removed.
2.2.3 The aim is to dilate the Eustachian tube without structural damage.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 A case series of 8 patients (a total of 13 treated Eustachian tubes) reported that the mean Eustachian tube score (range 0–10) improved from 1.08 at baseline to 4.15, 5.85 and 7.54 at follow-up of 1, 2 and 8 weeks postoperatively respectively (p < 0.05).
2.3.2 A case series of 30 patients (a total of 53 treated Eustachian tubes) reported that 60% of patients felt that their aural fullness had resolved (follow-up not stated).
2.3.3 The Specialist Advisers listed key efficacy outcomes as improvement of tubal function, resolution of symptoms, and fluid drainage from the middle ear.
2.4.1 The case series of 8 patients reported that there were no intraoperative or postoperative complications.
2.4.2 A case series of 30 patients reported that no patients had any postoperative pain, hearing loss or infection. A case series of 11 patients reported that the procedures were well tolerated, without pain or complications.
2.4.3 The Specialist Advisers listed adverse events reported in the literature as mucosal tears in the cartilaginous portion of the Eustachian tube. They considered theoretical adverse events to include rupture of the internal carotid artery, permanent conductive hearing loss, damage to the Eustachian tube, scarring, stenosis, ear infection and pain.