FDA proposes guidance to clarify differences between hearing aids and PSAPs

By David H. Kirkwood ROCKVILLE, MD–The U.S. Food and Drug Administration (FDA) issued a draft guidance document on November 7 designed to clarify “the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the regulatory controls that apply to each.” It invited public response to the draft by February 5, 2014.…

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Professional groups ask FDA to stop sale of hearing aids disguised as personal amplifiers

By David H. Kirkwood WASHINGTON, DC–Three national associations of hearing care professionals have added their voices to that of the Hearing Industries Association (HIA) in calling on the Food and Drug Administration (FDA) to take action to curb the sale of hearing aids under the guise of personal sound amplification products (PSAPs). Although the manufacture,…

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Hearing aid sales to hi HealthInnovations help put IntriCon back in the black

ARDEN HILLS, MN—While a warning letter from the Food and Drug Administration (FDA) has put a hitch, at least temporarily, in hi HealthInnovations’ (HI) online hearing testing and hearing aid dispensing program, the company that manufactures the devices for HI is thriving. IntriCon Corporation reported that its sales increased by 20% in the first quarter…

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Manufacturers group asks FDA to crack down on crypto-hearing aids

By David H. Kirkwood WASHINGTON, DC—The Hearing Industries Association (HIA) has called on the Food and Drug Administration (FDA) to start enforcing its regulations governing hearing aids, even when the devices are ostensibly “personal sound amplification devices” or PSAPs. In an April 19 letter to Steven Silverman, director of the Office of Compliance at FDA’s…

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