FDA
Hearing loss is a communication disorder that affects physical and emotional health. It calls for intervention and treatment. However, professional help may be hard to find and hearing aids are often unaffordable for many of those with hearing loss. To provide more accessible and affordable options, FDA-regulated Over-the-Counter (OTC) hearing aids were released for retail…
Read MoreSPI-1005 finished Phase 3 clinical trials with positive results In 2021, I wrote a blog about an investigational new oral drug for treating Ménière’s Disease. Known as SPI-1005, it contains ebselen, a new chemical with antioxidant and anti-inflammatory activity. At the time, participants with a definite history of Ménière’s Disease were recruited for SPI-1005 Phase 3…
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OTC hearing aids will be “self-fitting,” non-prescription devices. They will be regulated by the Food and Drug Administration (FDA) but people can buy them Over-the-Counter without a prescription or the input of any professional help. Would-be users will be on their own when it comes to deciding if they qualify for these devices because they are…
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