Pedmark Approved for Pediatric Cisplatin-Associated Ototoxicity
The approval was based on data from 2 pivotal phase 3 trials, which evaluated Pedmark in pediatric patients undergoing treatment with cisplatin-based chemotherapy.
Diagnosis & Disease Information
FDA Issues Final Rule for Over-the-Counter Hearing Aids
The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.
FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Hearing Loss Rates Expected to Double in US by 2060
Increase will be greatest among adults over 70, researchers say.
Hearing Impairment Decreasing in Americans Under 70
Hearing impairments are still common, but noise-safety rules and changing smoking patterns may have helped its downward trend.
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