FDA Clears Automated Ear Cleaning Device for Earwax Removal
OtoSet is an automated ear cleaning device that resembles a set of headphones.
Otic Disorders
Generic Version of Ciprodex Otic Suspension Now Available
The otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid.
Ear Precipitate Formation Following Otitis Externa Treatment
Upon examination, the patient’s external ear canal was found to be inflamed, red, and swollen, and she was subsequently diagnosed with otitis externa.
Pedmark Receives Priority Review for Prevention of Cisplatin-Induced Ototoxicity
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
FDA Clears TOMi Scope for Noninvasive Imaging of Middle Ear
The Food and Drug Administration has granted 510(k) clearance to TOMi Scope (PhotoniCare) as an imaging tool for visualization of the human tympanic membrane and middle ear space.
FDA Approves Ear Tube Delivery System That Does Not Require General Anesthesia
The FDA has approved the Tubes Under Local Anesthesia (Tula) System (Tusker Medical) for the treatment of recurrent otitis media in patients ≥6 months of age.
MPR Weekly Dose Podcast: Episode 14
This week on the Pod we talk about the FDA Advisory Committee vote on Vascepa; Antibiotic resistant threats; New contact lenses approved to slow myopia in children; A new treatment for sickle cell disease; And an approval for the rare disease, acute hepatic porphyria.
FDA Grants Fast Track Status to FX-322 for Sensorineural Hearing Loss
Based on results from the phase 1/2 trial, FX-322 was found to be safe and well-tolerated with no serious adverse events.
New OTC Artificial Tear Formulations Available for Relieving Eye Dryness
Allergan has announced the addition of 3 new over-the-counter artificial tear products to their Refresh line.
