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20Q: Ototoxicity and Audiology - Insights from an Innovator

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1.  The author provides the following advice for audiologists wishing to gain expertise in ototoxicity? A strong basic science and clinical audiology background combined with a PhD from a university doing research in this area Familiarity with ASHA and AAA guidelines for ototoxicity monitoring, as well as Common Terminology Criteria for Adverse Events classification system Experience serving on committees developing and writing guidelines All of the above

2.  How do patents or other forms of intellectual property protection help get new technologies to patients? They don't - they only drive up costs to consumers Technologies in the public domain get fast-tracked through the FDA approval process They enable companies to support the technologies through extensive clinical and pre-clinical trials testing, knowing they have the opportunity to eventually make a profit or at least break even They allow other companies to immediately develop the same technologies and generics so that the market is flooded the new technology

3.  To participate in an audiology clinical trial, it is important to be able to: Follow strict protocols, adhere to the rigid test schedule, and follow standard data collection and reporting processes Follow a protocol that is best for your patients, and be flexible to adapt processes to your schedule Have a PhD Hire staff to manage all the paperwork

4.  Which area of ototoxicity research does the author suggest may move ahead the fastest? inner hair cell regeneration auditory nerve regeneration agents for cisplatin-induced hearing loss reversal of blast-induced barotrauma

5.  Which of the following is a challenge to conducting clinical trials to address noise-induced hearing loss? There are no potential otoprotective agents to test There is no funding for this type of research There is no interest among researchers to participate in this type of research Difficult to identify clinical trials populations with sufficient numbers who meet study criteria, and issues with differences in placebo v. study groups