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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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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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…

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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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Professional groups take unified stand on direct-to-consumer hearing aid sales

LIVONIA, MI–Although United Healthcare (UHC) and leaders of several professional associations in hearing care sat down last month to talk with one another (see our February 7 post), there’s little sign that the differences between them can be reconciled. On the one hand, UHC’s subsidiary, hi HealthInnovations, seems fully committed to selling hearing aids directly…

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New online hearing aid debuts; online hearing test to follow

PHILADELPHIA–One of the latest entries in the fast-growing field of direct-to-consumer hearing aid sales is Embrace Hearing. Founded by two former classmates at Stanford University, Sam Tanzer and Ross Porter, the Philadelphia-based retailer claims to offer “high-quality hearing aids” for $299 and up. According to Embrace, its digital, custom-programmed hearing aids are manufactured in the…

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