Hearing loss is associated with a wide range of health problems, including stress, anxiety, depression, high blood pressure, and heart disease, according to the Centers for Disease Control and Prevention (CDC).
Lower maximum sound output to reduce the risk of hearing damage.The regulations also call for some safety measures designed to prevent hearing loss or damage to the ear canal, including:
Children and teens with hearing loss, and some adults with severe hearing impairment, will still need prescriptions. Under the new regulations, hearing aids will become available without a prescription for people 18 and older. Califf said.Ī study published in October 2020 put the average out-of-pocket costs for prescription hearing aids at about $2,500, a price too steep for three-quarters of Americans with functional hearing loss to afford. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” Dr. “Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said the FDA's commissioner, Robert M. Hearing aids could be in stores as early as mid-October, the FDA said. Food and Drug Administration (FDA) has approved the sale of over-the-counter hearing aids, a move that may make the devices cheaper and easier to access for millions of Americans.Ĭonsumers with mild to moderate hearing loss will be able to purchase hearing aids at retail stores and online without a medical exam, prescription, or fitting adjustment from an audiologist, the FDA said in an August 16 statement.
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