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.
Based on results from the phase 1/2 trial, FX-322 was found to be safe and well-tolerated with no serious adverse events.
The FDA has approved SYNCHRONY and SYNCHRONY 2 (MED-EL) cochlear implant systems for single-sided deafness and asymmetric hearing loss.
By using smartphone microphone, speaker to assess eardrum mobility, app can detect middle ear fluid
Recommendations have been developed for use of polymyxins, focusing on polymyxin B and polymyxin E (colistin); the guidelines were recently published in Pharmacotherapy.
“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.
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.
For the migraine and non-migraine cohorts, the incidence rates of cochlear disorders were 81.4 and 29.4 per 1 million person-years, respectively.
