Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.

Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.

U.K. startup Tympahealth Technologies Ltd. has received $8 million in seed financing for commercialization of its point-of-care hearing health assessment system. The Tympa system is a CE marked and FDA-registered device for high-resolution ear drum visualization, ear wax removal and hearing screening assessments. Health care entrepreneurs Maurice Ferre and Arjun Desai led the financing round.

Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.

Each year, more than 250,000 Americans undergo sinus surgery to treat a range of nose and sinus complaints. Full recovery can take several weeks, during which patients typically use opioids to treat their postoperative pain. Given the risk of opioid addiction, Tivic Health Systems Inc. is testing a bioelectronic device that offers an alternative to potent narcotics following sinus surgery.

PARIS – The team from the ENT surgery department at Clermont-Ferrand University Hospital recently placed a cochlear implant into a patient with profound deafness using the Collin Medical SAS otologic robot in a hybrid operating room known as Imabloc.

The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.