Wednesday, February 5, 2014

HLAA Comments on PSAPs and Hearing Aids

Of Interest to Chapter Members Coast to Coast
HLAA Comments on PSAPs and Hearing Aids

The Hearing Loss Association of America filed comments with the Food and Drug Administration (FDA) regarding their draft guidance titled  "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.''

This draft guidance is intended to clarify the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is not final nor is it in effect at this time.

In our comments, HLAA raises concerns with the draft guidance, and urged the FDA to seek input from a broad range of stakeholders to work together to craft a document that is helpful to industry, providers and consumers alike as well as provide for greater education of consumers.

To read the comments, click here.

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