Government Regulation of Hearing Healthcare, part 2

Several posts ago, Hearing Economics looked at the Supply Curve in a free market and likened independent Audiologists to wheat farmers, in the sense that they exercise little if any influence on Pricing.  That post evoked comment from a regular reader: C:  Holly, you using the analogy of how hearing aid professionals are like wheat…

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Back to the Future, part VIII: Bimodal Is as Bimodal Does

Editor’s note:  This series follows predictions by Lars Kolind[1] in the 1990s.    Today’s post– the grand finale in this series–considers Dr. Kolind’s final prediction of a Brave New World that looks a good deal like a high volume version of the Old World.  We have arrived at this point after posts on Predictions I through VII,…

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Regulation of Hearing Aids in the US, part 7 (the end!)

  Back to the Future:  Current Thinking at the FDA and in the Marketplace The burden of regulation continues to haunt the hearing aid industry and cost consumers.  Notwithstanding the entrenched regulatory mentality described in Parts 5 and 6 of this series, there were two interesting Citizen’s Petitions that were filed with the FDA in…

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Regulation of Hearing Aids in the US, Part 6 (it’s a long story)

The 1977 Final Rule Revisited… Revisited… Revisited …and Kept   Technological progress and market needs moved the industry forward, but the Final Rule remained as stated in 1977.  For example, in 1985, the FDA approved the Nuclear 22 Channel Cochlear Implant system for general use in adult patients with profound hearing loss after the device…

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Regulation of Hearing Aids in the US, Part 5

The FDA Regulation: 1977 Final Rule By 1977, the momentum driving hearing aids into the medical device arena was unstoppable. On Feb. 15, 1977, the FDA published its Final Rule, which made hearing aids restricted devices, promulgated regulations governing professional and patient labeling, and set forth conditions for the sale of hearing aids.1 The detail…

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