The U.S. Food and Drug Administration (FDA) is continuing to split hairs as it attempts to draw a clear distinction between hearing aids, which are Class I medical devices subject to government regulatory oversight, and personal sound amplification products (PSAPs), which are not. While its recent draft guidance document updating its 2009 Regulatory Requirements has more … [Read more...] about FDA Still Struggles To Explain Difference Between Hearing Aids And PSAPs
Hearing Protection
Naming Names: Hearing Health Groups Ask FDA To Force Four Personal Amplifier Marketers To Stop Calling Their Products Hearing Aids
Many of the established players in the hearing industry have long been upset about lack of clarity in the lines drawn between hearing aids, which are regulated medical devices, and personal sound amplification products (PSAPs), which are unregulated. Now three major hearing health organizations are tackling the issue head on by calling on the U.S. Food and Drug Administration … [Read more...] about Naming Names: Hearing Health Groups Ask FDA To Force Four Personal Amplifier Marketers To Stop Calling Their Products Hearing Aids
Private Equity Investment Positions Westone Labs To Drive Growth In Consumer Hearing Device Markets
Now that private equity firm CID Capital has made a major investment in Westone Laboratories, watch for the Colorado company turn on the burners with a further expansion of its hearing-assistance products into new consumer markets beyond the hearing-aid industry. Not that long ago, Westone was little more than a staid maker of ugly but essential custom ear molds for hearing … [Read more...] about Private Equity Investment Positions Westone Labs To Drive Growth In Consumer Hearing Device Markets
Why Lantos Technologies’ Search For The Perfect Earmold Is A Game-Changer For The Hearing Aid And High-End Audio Industries
Lantos Technologies, a Cambridge, Massachusetts startup company working with patented technology developed at MIT, is on a quest for the perfect ear mold fitting. With $1.6 million in venture capital funding, the company is developing a unique scanner that will create an exact digital image of the inner ear, enabling ear mold manufacturers to produce hearing-aid shells, … [Read more...] about Why Lantos Technologies’ Search For The Perfect Earmold Is A Game-Changer For The Hearing Aid And High-End Audio Industries
How Much Government Regulation Should There Be Of Noise And Hearing Loss In The Workplace?
Manufacturers of personal hearing protection solutions are missing an opportunity by not raising their voices to be heard in the debate over government regulations limiting noise in the workplace. When two U.S. Senators this week persuaded the U.S. Labor Department to back off from proposed rule changes that would have required large and small companies to more aggressively … [Read more...] about How Much Government Regulation Should There Be Of Noise And Hearing Loss In The Workplace?