FDA - Archive

FDA is extending public comment time for Hearing aids

January 8, 2016 in Hearing Aids, Legislation, Technology

 

The Hill
By Tim Devaney – 01/06/16

Hearing aids: The Food and Drug Administration (FDA) is delaying new guidelines for hearing aids.

The FDA issued draft guidance for “hearing aid devices and personal sound amplification products” in 2013 but is now reopening the comment period to give the public more time to discuss.

The public has 120 days to comment.

Source The Hill

The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

January 7, 2016 in Advocacy & Access, Hearing Aids

 

For Immediate Release

January 6, 2016

The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).

According to statistics compiled by the National Institute on Deafness and Other Communication Disorders (NIDCD), 37.5 million adults aged 18 and older in America report some form of hearing loss. However, only 30 percent of adults aged 70 and older and 16 percent of adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them. NIDCD is part of the National Institutes of Health.

“The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”

Read entire FDA Press Release

What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

June 26, 2015 in Advocacy & Access, Community News, Hearing Loss & Deafness

 

 

Regulatory Affairs Professional Society
By Alexander Gaffney, RAC
June 24, 2015

 

The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising.

Background

The study, announced in a 24 June 2015 posting in the Federal Register, is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug advertising and how one’s spouse might affect one’s understanding of drug risks and benefits.

As FDA explains in its Federal Register notice, the elderly often find themselves in a difficult situation: At a time when they are often taking an increasing number of prescription pharmaceutical products to counteract the effects of aging, their ability to understand the benefits and risks presented by those products is often diminished.

Read More  . . .  Drug Ad 

Manufacturers Group Asks FDA to Crack Down on Crypto-Hearing Aids

June 5, 2012 in Technology

By David H. Kirkwood, Hearing Health Matters 4/2/2012 http://tinyurl.com/8xyun8x
Thanks to Bob MacPherson
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 Center for Devices and Radiological Health, Jeffrey Gibbs, HIA’s counsel, cited a number of products that are being sold online without FDA’s clearance even though, he said, they are clearly intended to be used as hearing aids, and not as PSAPs, which are not approved for use by people with hearing loss.   Read more . . . →