FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Miscellaneous Ear Disorders
Osteoporosis, Low Bone Density May Contribute to Hearing Loss
Magnitude of elevated risk similar among women who did and did not use bisphosphonates
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
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.
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.
Cochlear Implants for Single-Sided Deafness, Asymmetric Hearing Loss Get FDA Approval
The FDA has approved SYNCHRONY and SYNCHRONY 2 (MED-EL) cochlear implant systems for single-sided deafness and asymmetric hearing loss.
Smartphone App Could Help Diagnose Ear Infections
By using smartphone microphone, speaker to assess eardrum mobility, app can detect middle ear fluid
Guidelines Developed for Polymyxin Antibiotic Use
Recommendations have been developed for use of polymyxins, focusing on polymyxin B and polymyxin E (colistin); the guidelines were recently published in Pharmacotherapy.
