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TIA Files Comments with FDA on Personal Sound Amplification Devices

Arlington, VA (February 6, 2014) – The Telecommunications Industry Association (TIA), the leading association representing the manufacturers and suppliers of high-tech communications networks, has filed comments with the Food and Drug Administration (FDA) on its draft guidance regarding hearing aids and personal sound amplification devices (PSAPs).

TIA believes that the FDA’s guidance documents are crucial towards enhancing healthcare in the United States.  The guidance will provide clarity in the FDA’s treatment, particularly for hearing aids and PSAPs, for the developers of innovative products and solutions that benefit millions of Americans with hearing loss.

In its filing, TIA:

• Encouraged the FDA to provide more clarity to the understanding of what a PSAP is by addressing definitional scope, using numerous and easily-understood examples, and reiterating that its “intended use” standard is an objective intent test;

• Urged for the use of enforcement discretion for PSAPs which may meet the definition of medical device but which pose little or no potential risk to consumers; and

• Encouraged the FDA to allow PSAPs’ labeling and marketing materials to address hearing loss to prevent any potential consumer confusion and to allow for informed purchases.

TIA’s full comments to the FDA are available here.

About TIA

The Telecommunications Industry Association (TIA) represents manufacturers and suppliers of global communications networks through standards development, policy and advocacy, business opportunities, market intelligence, and events and networking. TIA enhances the business environment for broadband, mobile wireless, information technology, networks, cable, satellite and unified communications. Members' products and services empower communications in every industry and market, including healthcare, education, security, public safety, transportation, government, the military, the environment, and entertainment. Visit tiaonline.org for more details.

TIA is accredited by the American National Standards Institute (ANSI), and is a proud sponsor of ANSI’s Standards Boost Business campaign. Visit www.standardsboostbusiness.org for details.

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