The FDA jumps to approve when Apple approaches. This sounded familiar, and merits a look back to a blog post from September 2018: “When Apple speaks, a puzzled market listens.When Apple announces, industries crane their necks to hear. They announced two features of a new watch, ECG monitoring and fall detection. In July, Tim Cook apparently did not want to get into the world of FDA regulation. Well, that was then – or he just wasn’t saying. In this new watch, both the ECG feature and fall detection have received FDA clearance within 30 days of applying, startling some observers who noted that closer to 150 days was more typical for a medical device. Healthcare observers are concerned that false positives from ECG readings could propel people unnecessarily to already-overloaded Emergency Rooms. To date, the Apple Watch may have been of greatest interest to 40 year old males. Interestingly, 70% of cases of atrial fibrillation are among the 65+ population. Does Apple really want the 65+ population to buy an Apple watch?” Did it happen?
The population is aging – and still, the tech solution market is immature. Investors of all types demonstrate interest in a product here and an offering there. Competitions highlight product winners; money is raised for one product at a time. One reason for the immaturity of the market is the behavior of buyers. Senior living companies buy a product for this and an offering for that. The future is predicted to incorporate new technology like AI – but that is always ‘in the future.’ Everyone agrees that AI could enhance retirement living and healthcare, but deployment of new offerings is always described as in the future. No other software categories in tech history – consider office, finance, supply chain – remain a laundry list of point products when markets expect suites.
BELLEVUE, Wash., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Medical device and consumer electronics manufacturer Nuheara Limited (ASX:NUH) (Company or Nuheara) is pleased to announce a major expansion of its US retail footprint, from circa 300 points of sale currently to circa 4,600 over the coming months, with US FDA cleared self-fit hearing aids now being manufactured to fulfill initial orders from Best Buy and other US retail customers.
Memorandum of Understanding (MoU) signed with InnerScope to sell Nuheara OTC self-fit hearing aids in c1,500 Walmart and c1,700 Rite Aid stores
Was this a ‘breakthrough’ on hearing aid pricing? Mull over the phrase from the KFF announcement (italics are mine), “Prices and features will vary for the new OTC hearing aids — much as they do for prescription aids. A pair of prescription devices typically sells for $2,000 to $8,000. Some of the technology found in the pricier prescription aids will be available in the cheaper OTC aids.” This was also true of the Personal Sound Amplification Product” (PSAP), described in 2017 as being helpful to people with mild to moderate hearing loss. What took the FDA 5 years to complete final review of essentially the same technology available in 2017, especially when they were ordered by Congress to do so? Note hat 48 million Americans have some degree of hearing loss (more than 400 million worldwide) and most do not have any hearing assistance devices. Note that uncorrected hearing loss is correlated with dementia.
The FDA jumps to approve when Apple approaches. This sounded familiar, and merits a look back to a 
The population is aging – and still, the tech solution market is immature. Investors of all types demonstrate interest in a product here and an offering there. Competitions highlight product winners; money is raised for one product at a time. One reason for the immaturity of the market is the behavior of buyers. Senior living companies buy a product for this and 
