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 […]
Otolaryngology/Ear, Nose & Throat (ENT)
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 […]
Inspire Medical appoints new independent board directors
Inspire Medical Systems (NYSE:INSP) announced today that it appointed Cynthia Burks and Dr. Charisse Sparks as board directors. The appointment of Burks and Sparks as independent directors to the board of the minimally invasive sleep apnea treatment developer was made effective on July 28, 2022. Burks previously served as chief human resources officer for Genentech […]
Bose partners with Lexie Hearing on self-fitting hearing aids
Lexie Hearing and Bose announced today that they partnered to bring Bose’s self-fitting hearing aid technology to Lexie’s product line. The new Lexie B1 hearing aids will be powered by Bose to allow wearers to fit, program and control their hearing aids with clinically proven, audiologist-quality results, without requiring a doctor visit, hearing test or […]
New data backs Aerin’s RhinAer for treating chronic rhinitis
Aerin Medical today announced the publication of positive results from a 12-month study of its RhinAer platform. Results from Sunnyvale, California–based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum of Allergy & Rhinology (IFAR), demonstrated that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer. Findings build on […]
Lyra Therapeutics appoints new chief medical officer
Lyra Therapeutics (Nasdaq:LYRA) announced today that it appointed Dr. Richard Nieman as its new chief medical officer (CMO). Nieman’s appointment as CMO of Lyra, which develops the XTreo — a platform for enabling precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues — will be made […]
Aerin Medical reports positive 4-year results for VivAer treatment
Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, California–based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the […]
Envoy Medical wins FDA IDE for Acclaim cochlear implant
Envoy Medical announced today that it received FDA investigational device exemption (IDE) for its Acclaim cochlear implant. White Bear Lake, Minnesota–based Envoy Medical will begin a single-center IDE early feasibility study with the fully implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota. The company said in a news release that its Acclaim implant […]