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FDA Issues PSAP Guidance

As FDA Clinical Deputy Director, Dr. Eric Mann advised HIA at its February Annual Meeting, the Agency has issued "Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs)."

A guidance document "represents the Food & Drug Administration's (FDA's) current thinking on this topic," and does not bind either FDA or the public to the approach. Dr. Mann outlined the likely approach to HIA members, and the document reflects what he described at the meeting. Basically, if the amplifier advertising does not state that it is intended to compensate for impaired hearing but says it will help when a person hunts or eavesdrops on a neighbor; it is a PSAP due to its intended use.

The Agency's position was anticipated by HIA but does little if anything to alert potential purchasers to the fact that PSAPs are not hearing aids. The industry's concern continues to be that people will be disappointed by PSAPs and will generalize to hearing aids, thus delaying even more the usual 8 years after which people acknowledge their hearing problem but do not take corrective action. While more studies are needed to confirm, an article in the March 2009 The Hearing Journal, authored by Dr. David Hawkins and AuD student Greta Stampler summarizes, "If someone with a typical sloping, high frequency hearing loss buys a device...little if any benefit would be expected. Perhaps if the "but wait...there's more!" part of the offer was a set of knives, a pasta cooker or a highly absorbent cloth, that would give the purchase some redeeming value."

HIA is pursuing options for better disclosure in concert with the consumer organizations.

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