Otic Disorders

The approval was based on data from the phase 3 BUTTERFLEYE and FIREFLEYE trials.

Socially disadvantaged children less likely to receive treatment for recurrent or suppurative otitis media

Pedmark is the first FDA-approved therapy indicated to reduce the risk of cisplatin-induced hearing loss in children.

The approval was based on data from 2 pivotal phase 3 trials, which evaluated Pedmark in pediatric patients undergoing treatment with cisplatin-based chemotherapy.

The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.

No increased risk for tinnitus seen with low-dose aspirin, but increase seen with moderate-dose aspirin for those younger than 60 years, NSAIDS, acetaminophen

The application could not be approved in its present form due to manufacturing deficiencies.

Proposal would create a category of hearing aids that could be sold directly to consumers, without medical exam or audiologist fitting

Study findings did show high adherence to guidelines with respect to medication use.

Cumulative incidence highest in patients aged 5 years and younger; factors that influence development include cumulative dose of cisplatin

Magnitude of elevated risk similar among women who did and did not use bisphosphonates

Rate of episodes of acute otitis media not significantly lower with tympanostomy-tube placement versus medical management

Current evidence insufficient for assessing balance of benefits and harms of screening for asymptomatic older adults

OtoSet is an automated ear cleaning device that resembles a set of headphones.

The otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid.

Upon examination, the patient’s external ear canal was found to be inflamed, red, and swollen, and she was subsequently diagnosed with otitis externa.

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.

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.

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.

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.