A rising IntriCon will provide hearing aids to the UK’s National Health Service

By David H. Kirkwood ARDEN HILLS, MN—Hearing care providers are familiar with the world’s “Big Six” hearing aid manufacturers, or at least their flagship brands. That’s only natural, as together Sonova, William Demant, GN Store Nord, Siemens, Starkey, and Widex account for over 90% of the devices sold in the U.S. and Western Europe. However,…

Read More

Consumer Electronics Association calls PSAPs an affordable alternative to hearing aids

By David H. Kirkwood ARLINGTON, VA—A Consumer Electronics Association (CEA) report concludes that personal sound amplification products (PSAPs) “offer a viable solution to hearing aids for consumers who have hearing difficulty.” It continues, “While consumers who suffer from more severe hearing difficulties may still require hearing aids, PSAPs offer a simpler and often less expensive…

Read More

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…

Read More

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…

Read More

Product performing functions of a hearing aid and a cochlear implant is approved

SILVER SPRING, MD–A new hybrid cochlear implant system that combines the functions of a cochlear implant and a hearing aid received clearance on March 20 from the U.S. Food and Drug Administration (FDA). Developed by the Australian company Cochlear Limited, the Cochlear™ Nucleus® Hybrid Implant System is the first solution designed for adults who have…

Read More

FDA’s proposed new PSAP policy draws mixed response, but mostly opposed

  By David H. Kirkwood SILVER SPRING, MD–The U.S. Food and Drug Administration (FDA) has  more than 100, highly diverse, public comments to consider in deciding if it should implement or rethink a proposed new guidance document that it issued on November 7. The document, drafted by the Ear, Nose, and Throat Devices Branch of…

Read More

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…

Read More

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…

Read More

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…

Read More

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.…

Read More