Researchers from the University of Auckland have developed a smartphone app called Mindear that reduced the impact of tinnitus in two-thirds of users over eight weeks.Tinnitus, often referred to as ringing in the ears, is the perception of sound without an external source and affects 10% to 15% of the global adult population. Previous studies to treat tinnitus have focused on neuromodulation devices, but a smartphone app could make treatment more accessible to a wider population.
To restore hearing function in patients with hearing loss or deafness, cochlear implantation is seen as the only method that works, but insertion of the electrode array may cause direct mechanical injury to the cochlea, with the subsequent loss attributed to an inflammatory response driven by proinflammatory cytokines, reactive oxygen species and apoptotic signals.
The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
Aerin Medical Inc.’s funding nosed up to $190.5 million with its latest venture capital round, which brought in $60 million in fresh cash. The provider of noninvasive solutions for chronic nasal conditions plans to use the funds to ramp up commercialization and expand market access to its Vivaer and Rhinaer products. New investor Ally Bridge Group led the round with support from returning major investors KCK Medtech, Questa Capital and Orbimed.
Lyra Therapeutics Inc.’s $100.5 million private placement has investors moving to the tune of the ear, nose and throat specialty therapeutics company. Lyra’s stock (NASDAQ:LYRA) jumped from early April trading in the $4.20 range to $6.02 with the announcement April 8 of the pending placement. The stock shot up again on April 13 when the placement finalized and surged in after-hours trading, ultimately spiking over $7 shortly after the opening bell April 14.
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.