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Open Letter to FDA Drug Trials re Sound Pharmaceuticals Feb 2018 SPI-1005 clinicaltrials.govNCT02779192

[October 30, 2018: still not recruiting] Feel free to use content of this letter as needed. FDA Drug Trials Email: CDER-OSI-GCPReferrals@fda.hhs.gov Regarding: https://clinicaltrials.gov/ct2/show/NCT02779192 To whom it may concern, Please terminate Sound Pharmaceuticals, Inc. clinicaltrials.govNCT02779192 planning to recruit participants with noise-induced hearing loss with anticipated start date in February 2018. The noise trauma TTS methodology designed …

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Ethics of NIHL, HHL-TTS Denial & Scientific Journal Trust

Physically there is no difference between occupational and recreational noise trauma. Loud noise or music causes triple hearing system damage: permanent hidden hearing nerve damage [HHL], temporary or permanent tinnitus-hyperacusis, and NIHL [Noise-Induced Hearing Loss] that is either temporary from short/occasional unprotected exposure or permanent from chronic unprotected exposure. Kujawa and Liberman identified HHL or …

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Hidden Hearing Loss? No Effect of Common Recreational Noise Exposure?

[Oct 30, 2018-still not recruiting] This study by Grinn et al. (2017),¬†Hidden Hearing Loss? No Effect of Common Recreational Noise Exposure on Cochlear Nerve Response Amplitude in Humans, concludes that researchers should use noise trauma causing TTS on human subjects to study otoprotective pharmaceutical drugs. This is not only highly unethical, but appears to be …

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