Millions of Americans could have access this fall to less expensive hearing aids sold over the counter without a required doctor exam and prescription.
Millions of Americans will have access to purchase hearing aids over-the-counter under a new FDA rule.Millions of Americans could have access this fall to less expensive hearing aids sold over the counter without a required doctor exam and prescription. by mid-October for people with mild to moderate hearing loss. Regulators said the new rule should give millions of adults less expensive options and broaden access for those who can't afford hearing aids.
The agency estimates the new class of devices would save consumers about $2,800 for a pair of hearing aids, officials said. Some hearing aids cost more than $5,000 between the price of the device and a professional fitting. Medicare covers a diagnostic test but does not pay for the device. Califf said the agency evaluated safety concerns about sound output limits for the new class of hearing aids. Devices with high sound output levels could potentially jeopardize long-term hearing while devices without enough sound could be ineffective. The rule comes five years after Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to authorize the sale of over-the-counter hearing aids.
While the new rule could provide affordable options for millions of people with hearing loss, some urged consumers to be careful. A limited number of hearing aids are being sold directly to consumers now. Bose received FDA clearance in 2018 to sell hearing aids directly to consumers. The companythis year and now partners with Lexie Hearing, which sells a device incorporating Bose's technology for $899.
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