September 7, 2012

ASHA Files Joint Letter With FDA Regarding Retail Sale of Hearing Aids and PSAPs

The American Speech-Language-Hearing Association (ASHA), Academy of Doctors of Audiology (ADA), and International Hearing Society (IHS) filed a joint letter to the U.S. Food and Drug Administration (FDA) urging the agency to address concerns with hearing aids being sold as Personal Sound Amplification Products (PSAPs).

We stated our belief to the FDA that many companies—themselves or through retailers—may be marketing hearing aids directly to consumers as personal sound amplifiers. In at least one case, different sellers are marketing the same product (i.e., hearing aids) differently—in some instances as hearing aids and in others as PSAPs. We urged FDA to investigate several products sold by retailers to determine whether they are violating FDA disclosure regulations and, if appropriate, to send warning letters instructing violating parties to cease and desist marketing and/or distributing these products for not complying with FDA requirements.

FDA regulates hearing aids as medical devices under the Food, Drug, and Cosmetic Act. A PSAP is a device to enhance normal hearing, rather than to address a hearing deficiency; as such, PSAPs are not subject to FDA hearing aid device regulations. Our letter identifies several products that are advertised as being "designed for mild to moderate hearing loss"—or provide significant decibel (dB) gain—and are labeled as PSAPs rather than hearing aids. We urged the FDA to investigate these unregulated products, which may in fact address hearing impairment. In addition, we, ADA, and IHS encouraged FDA to clarify and strengthen its regulations over companies that may be illegally marketing hearing aids as PSAPs.


  

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