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

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

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…

Read More

Ohio tries to curb online hearing aid sales

COLUMBUS, OH—Reacting to the growing prevalence of direct-to-consumer hearing aid sales, the Ohio House of Representatives is considering legislation that would ban the sale of hearing aids to any Ohio resident who has not received an in-person hearing evaluation at a location within the state. Introduced in March by Rep. Rex Damschroder (R-Fremont), House Bill…

Read More

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…

Read More

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…

Read More