HIA Asks eBay to Stop the Listing of Hearing Aids On Its Site
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July 26, 2005
Michael Jacobson
Senior Vice President & General Counsel
eBay, Inc.
2145 Hamilton Avenue
San Jose, CA 95125
Dear Mr. Jacobson:
In the best interests of 31.5 million Americans who report some degree of hearing loss, the Hearing Industries Association (HIA) respectfully requests that eBay halt the sale of hearing aids on its website.
Repeated visits to your site reveal that, on average, several hundred items appear when a visitor searches for hearing aids. While a substantial number of these items are actually hearing aid batteries, a majority are hearing aids and, as such, violate the stated eBay policy that Sellers may not list medical devices on eBay that require a prescription. Further, the eBay Medical Devices Policy encourages individuals to contact the US Food & Drug Administrations Center for Devices and Radiological Health, where the website warning cautions that consumers using the eBay Website should avoid: Any prescription drug or prescription device.
The 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.
A more difficult problem is encountered when one assesses the actual types of hearing aids for sale on eBay. Some of the hearing aids are behind-the-ear hearing aids that may be beneficial for a purchaser who has used that particular hearing aid model before and can purchase a custom earmold separately. Other sale items are non-custom, one size fits all, in-the-ear hearing aids that may indeed fit some percentage of purchasers to some degree. Other items, however, are in-the-ear hearing aids that have been custom-manufactured to fit inside someone elses 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 urges eBay to abide by its own medical device policy and restrict the sale of hearing aids on the site in the best interests of consumers with hearing losses. Our organization would be glad to amplify any aspects of the information in this letter as you consider this issue.
Sincerely,
Carole M. Rogin
Executive Director
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