Hearing Economics

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 had spent 10 years in

My feng sui is restored, thanks to the most unlikely of sources…. My state government!  At the end of 2010, I wrote about extreme discomfort brought about by the continuing education process in my State for dispensing audiologists, which required the craft skills of a kindergarten aide and not much else.  The worst part, however, was the discovery that my

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 and scope of the Final

 “Dress up and put on diamonds even to answer the phone, as it changes the way you are.”  Mae West Let’s take a break from the hearing aid history series and go check out the future of hearing aids. It’s probably safe to say that all economists agree that technology drives production and prosperity.  In most cases, prosperity translates into improvements

The evolution of the hearing aid industry sketched out in parts 1-3 of this post series is that of a consumer product.  From hand to horn to telephone-like device, the hearing aid was developed and thought of by manufacturers and consumers alike as an appliance that boosted sound.  In that regard, hearing aids were a closer fit to the personal stereo niche

The US Hearing Aid Industry Comes Under Scrutiny and Regulation by the FTC1 The industry’s expanding sales and capital were the result of technological innovation as well as intense marketing campaigns by the manufacturers.   Celebrity marketing and fake testimonials were a big part of these campaigns.  Luminaries ranging from Bob Hope to Bernard Baruch were used to endorse the products.

Electronic Hearing Aids At the turn of the 19th century, hearing aids underwent a technological revolution by emulating telephone technology.  The first electronic hearing aids used carbon microphones that modulated electrical current in response to sound pressure variations. Hearing Aids Become a Business Batteries and electronic components created a market for wearable amplification among people with hearing loss. Hearing aid

Hearing aids are categorized as Class 1 or Class 2 medical devices by the Food and Drug Administration. The large majority of hearing aids are in the Class 1 category, which means they are exempted from the premarket notification and FDA clearance requirement. Hearing aid manufacturers are required to register their establishments and bring their products into compliance with a

In the very first post (https://hearinghealthmatters.org/hearingeconomics/2011/case-of-the-de-capitated-audiologists/), we heard from Dr Rick Lazich and his partner, who were negotiating a contract for audiology services in state long-term care facilities. … and there were a bunch of dentists involved somehow.  At that point, his group had just ponied up big bucks to hire actuaries to help with the process. Today, he’s sent in an update as

The hearing aid industry made the financial pages recently, when the CEO, CFO, and Chairman of Sonova Holding AG announced their resignations, simultaneously and suddenly.  Sonova says it is the “world’s largest hearing-aid maker” and I’ll take their word for it.  Sonova owns a number of well-known hearing aid brands, such as Phonak, Lyric, Hearing Planet, and others.  Here is