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
Miscellaneous Ear Disorders
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.
FDA Approves Marketing of First User-Fitted Hearing Aid
“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device,” said Malvina Eydelman, MD, director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices.
Hearing Assessment Test Now Available for At-Home Screening
The approval of the test was based on a clinical study (N=96) which compared the iHEARtest with the WHO method for determining hearing impairment.
