MedWatch

Senators fear inadequate OTC regulation could harm hearing device users

In an open letter to US President Joe Biden, four senators sound the alarm over the chaos reigning on the hearing device market. Due to a lack of clear regulation ahead of the over-the-counter sales channel, low-cost manufacturers have begun selling "amplifiers" masked as real hearing aids, potentially harming users.

Photo: Evelyn Hockstein/Reuters/Ritzau Scanpix

Chaos reigns on the American hearing aid market, and Biden must act immediately. This message comes from four senators, who in a direct letter to President Joe Biden describe what they call "chaotic" and "confusing" conditions on a hearing aid market that is currently so unregulated, it might cause serious harm for hearing impaired people.

The letter, which MedWatch is in possession of and is dated Sep. 16, comes shortly after Biden's July announcement, which was an assault on the price of the established hearing aid industry's expensive products. In an executive order, Biden directed the US Department of Health and Human Services (HHS) to have proposed rules on the over-the-counter (OTC) sales of hearing aids – that is, without prescriptions or an audiologist appointment –  within 120 days.

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