Amplifon, a large Italian retailer of hearing aids, is expecting its first marketed products to be sold without a prescription in the US during the second half of 2022, the company revealed during its capital markets day on Monday.
The hearing healthcare company's expectation is that the proposed regulations on the OTC market, which would enable over-the-counter sales of hearing aids to adults with mild to moderate hearing loss – sidestepping an appointment with an audiologist – willl be presented by the US Food and Drug Administration (FDA) in November.
Hereafter, there will be a short window for industry objections and recommendations, before approximately six months of implementation commence.
The timeline therefore fits with the executive order that President Joe Biden signed at the beginning of July, which sent ripples through the hearing aid market.
In the order, Biden criticized the prices of hearing aids, which he thinks have become too expensive for US families. He therefore directed the FDA to propose rules for the over-the-counter sales of hearing aids within 120 days.