A new study published in JAMA demonstrated equal benefit for self-fitting, over-the-counter (OTC) hearing aids compared to prescription ones. Researchers at the University of Colorado and the University of Pretoria published their study. It went out in the April 13 issue of the Journal of the American Medical Association (JAMA) – Otolaryngology–Head & Neck Surgery. Using […]
Otolaryngology/Ear, Nose & Throat (ENT)
Neuromod Devices closes $33.2M financing for tinnitus-treating neuromodulation tech
Neuromod Devices announced today that it closed a $33.2 million (€30 million) financing round to support its tinnitus treatment device. Dublin, Ireland–based Neuromod Devices develops Lenire, a neuromodulation device for reducing tinnitus severity. The system received FDA de novo approval in March and has availability throughout Europe. Lenire delivers mild electrical pulses to the tongue […]
EvoEndo CEO to leave, replacement named
EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood. Denver-based EvoEndo, which develops transnasal endoscopy technology, named Jonathan Hartmann as president and CEO. It appointed Ryan Hartman to the COO position. Underwood intends to remain with the company through April to support the leadership transition. Underwood […]
Lenire non-invasive neuromod for tinnitus wins FDA de novo nod
Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for treating tinnitus. According to a news release, Lenire becomes the first bimodal neuromodulation device of its kind to receive FDA approval for treating tinnitus. “Lenire’s approval not only means that millions of Americans living with tinnitus can get the […]
Hearing aids start selling over-the-counter in U.S.
The White House announced the rollout of over-the-counter hearing aids at major U.S. retailers today. “Starting this week, we’re making hearing aids available over the counter, so people don’t have to pay for expensive visits to specialists,” President Joe Biden said on Twitter. In August, the FDA issued a final ruling to create a new […]
Sony launches its first over-the-counter, self-fitting hearing aids
Sony Electronics announced today that it launched its first over-the-counter (OTC) hearing aids for the U.S. market. The company developed unique products in partnership with hearing aid technology developer WS Audiology. Sony said they combine ease of use with comfort and wearability for an “unprecedented hearing experience.” Sony and WS Audiology began by launching two products […]
Lyra Therapeutics enrolls first patient in Phase 3 chronic rhinosinusitis trial
Lyra Therapeutics (Nasdaq:LYRA) announced today that it enrolled the first patient in its Phase 3 Enlighten II clinical trial. Enlighten II is evaluating the company’s LYR-210 in adult patients with chronic rhinosinusitis (CRS). Lyra’s proprietary XTreo platform delivers LYR-210. Watertown, Massachusetts-based Lyra designed the proprietary XTreo platform for precise, sustained and local delivery. The platform […]
FDA clears next-generation RhinAer stylus from Aerin Medical
Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus. Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session. The new RhinAer provides physicians with improved […]
FDA clears expanded labeling for Preceptis Medical’s ear tube system
Preceptis Medical announced earlier this week that the FDA cleared expanded indications for its Hummingbird tympanostomy tube system (TTS). New labeling for the Hummingbird system for office-based pediatric ear tube procedures allows for in-office procedures in all children 6 months and older. Previous FDA clearance allowed for the use in children between 6 months old […]
New FDA ruling may lower costs for over-the-counter hearing aids
The FDA today issued a final rule that may improve access to hearing aids by potentially lowering costs for the devices. By establishing a new category of over-the-counter (OTC) hearing aids, consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without the need for a medical […]
J&J’s Acclarent wins FDA clearance for navigated shaver blade for ENT procedures
Johnson & Johnson MedTech’s Acclarent business announced FDA 510(k) clearance for its TruDi shaver blade and its advanced navigation features. In a news release posted yesterday, Acclarent described TruDI as a single-use electromagnetically navigated blade. It’s used with the company’s Bien-Air S120 shaver for the incision and removal of soft and hard tissue or bone […]
