FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Otic Disorders
FDA Eases Access to Cheaper Over-the-Counter Hearing Aids
Proposal would create a category of hearing aids that could be sold directly to consumers, without medical exam or audiologist fitting
Watchful Waiting for Acute Otitis Media Often Not Followed in Primary, Acute Care Settings
Study findings did show high adherence to guidelines with respect to medication use.
Cisplatin-Induced Hearing Loss Up for Young Children With Cancer
Cumulative incidence highest in patients aged 5 years and younger; factors that influence development include cumulative dose of cisplatin
Osteoporosis, Low Bone Density May Contribute to Hearing Loss
Magnitude of elevated risk similar among women who did and did not use bisphosphonates
Tympanostomy-Tube Placement No Better for Recurrent Otitis Media
Rate of episodes of acute otitis media not significantly lower with tympanostomy-tube placement versus medical management
USPSTF: Evidence Lacking for Screening Seniors for Hearing Loss
Current evidence insufficient for assessing balance of benefits and harms of screening for asymptomatic older adults
FDA Clears Automated Ear Cleaning Device for Earwax Removal
OtoSet is an automated ear cleaning device that resembles a set of headphones.
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.
