As we reported in March, the FDA has been debating whether to create a class of over-the-counter (OTC) hearing aids to inspire new products costing hundreds, not thousands, of dollars. Congress and the president pushed the effort forward over the summer, approving the Over-the-Counter Hearing Aid Act in August. It gives the FDA three years to establish the OTC hearing aid category and develop safety and labeling rules for the devices. Last December, the FDA said it would no longer require adults to receive a medical evaluation or sign a waiver before purchasing most hearing aids. So now people with mild to moderate hearing loss don't need a doctor's prescription to get an OTC hearing aid, and don't need to see an audiologist for a fitting. OTC hearing devices aren't the same as prescription hearing aids, however. They're amplification devices, and they may not be right for your particular type of hearing problem. Without an evaluation by a doctor, an underlying condition may go undiagnosed. Discuss the risks and benefits with your primary care doctor.
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