The hearing aid market is growing slowly. So, what else is new?

By David H. Kirkwood WASHINGTON, DC–Consider all the reasons why hearing aid sales should have risen through the roof over the past decade or two. For one thing, there have been dramatic improvements in technology, fueled largely by the introduction of digital signal processing in the 1990s. Powerful 21st century hearing aid hardware and software…

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Soundhawk unveils its “smart listening system”; insists it’s not a hearing aid

CUPERTINO, CA—Soundhawk, a high-tech start-up company with an impressive pedigree, began taking advance orders last week on its web site for a $279 “smart listening system.” According to Soundhawk’s founder, Rodney Perkins, MD, an otologist at Stanford University School of Medicine and founder of the California Ear Institute, the new system “is the culmination of a…

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Hearing aid dispensing groups back new FDA restrictions on PSAPs; HLAA does not

  The following post was originally published on February 5 and updated on February 6. By David H. Kirkwood ROCKVILLE, MD–Three more organizations concerned with hearing submitted comments to the U.S. Food and Drug Administration (FDA) this week on the agency’s proposed guidance document, which would tighten existing restrictions on the marketing of personal sound amplification products…

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Hearing aid establishment and PSAP advocates clash over proposed FDA regulations

For an updated post on this subject, click here. By David H. Kirkwood ROCKVILLE, MD–A U.S. Food and Drug Administration (FDA) proposal to tighten existing restrictions on the marketing of personal sound amplification products (PSAPs) is arousing both a storm of criticism and strong support from various interested parties. Although the February 5 deadline for…

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After leading ReSound and InSound to success, two entrepreneurs try something different

By David H. Kirkwood SAN FRANCISCO/SAN LEANDRO—Hardly a week passes without at least one announcement of some new device being developed to help people with hearing loss. Whether these products are categorized as hearing aids, personal sound amplification products (PSAPs), or assistive hearing technology, they nearly all have a few things in common: (1) Although…

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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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Audiologists wage grassroots campaign against direct-to-consumer hearing aid sales

  By David H. Kirkwood When hi HealthInnovations announced two years ago that it would start selling “high-tech, lower cost hearing devices” directly to consumers, hearing healthcare organizations immediately denounced the plan. They contended that in bypassing the hearing professional, hi’s distribution model would provide inferior hearing solutions and would also endanger patients whose hearing…

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AAA kit helps audiologists make the case against direct-to-consumer hearing aid sales

By David H. Kirkwood For audiologists and other hearing healthcare providers, there’s been no more disturbing development in recent years than the explosion in the sale of hearing aids directly to consumer sales. When hard-of-hearing consumers buy hearing aids without the care of a trained professional, practitioners lose out on the revenues they would have…

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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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