July 26, 2005, the Hearing Industries Association (HIA) contacted eBay, a popular online marketplace, requesting that the company discontinue the sale of hearing aids on its website. The current eBay policy states that "Sellers may not list medical devices on eBay that require a prescription..." Repeated visits to eBay's site reveal that several hundred items appear when a visitor searches for "hearing aids." While these items include hearing aid batteries, a majority are hearing aids and, as such, violate the stated eBay policy.
The US Food & Drug Administration (FDA) considers hearing aids to be "restricted" Class I medical devices. Within the context of FDA regulation, "restricted" status gives "FDA explicit authority to establish standards for medical devices and to place conditions upon sale or distribution of a device...." Those conditions are delineated in 21 CFR Part 801 - Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale. Among those conditions for sale is the requirement for a medical evaluation by a licensed physician prior to purchase, although adults over the age of 18 may elect to waive that requirement by signing a statement to that effect, and the assumption that the hearing aid will be dispensed by a trained professional licensed to dispense hearing aids by virtually every state. Neither of these conditions can be met without a face-to-face interaction between seller and purchaser.
While a portion of the hearing aids on eBay are non-custom, one size fits and may fit a percentage of purchasers to some degree, other sale items have been custom-manufactured to fit inside someone else's ears and, despite a disclaimer that "some modification may improve fit," will never be of any use to the purchaser. Rather than trying to make distinctions between these types of hearing aids, HIA has urged eBay to abide by its own medical device policy and restrict the sale of hearing aids on the site. HIA has contacted eBay's General Counsel for further discussion.
