FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Hearing Loss
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
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
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.
Smartphone App Could Help Diagnose Ear Infections
By using smartphone microphone, speaker to assess eardrum mobility, app can detect middle ear fluid
Portable Music Player Use Linked to Hearing Loss in Children
Overall, 14.2% of all children had audiometric notches and high-frequency hearing loss; 4.5, 7.6, and 2.1% fulfilled the criteria of a notch, high-frequency hearing loss, and both, respectively.
FDA Fast Tracks Pedmark for Prevention of Cisplatin-Induced Ototoxicity
The Clinical Oncology Group Protocol ACCL0431 trial enrolled 125 pediatric patients newly diagnosed with a germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
HRT May Up Hearing Loss Risk in Postmenopausal Women
Older age at menopause also appears to increase the risk
