Apple May Break Into The Hearing Aid Industry

September 17, 2024 by Jenny List 33 Comments

When the entry of a tech giant such as Apple into a market represents its liberation from exploitation, that market must be really broken, yet the reported FDA approval of the hearing aid feature in the latest AirPod earbuds seems to represent just that. The digital hearing aid business is notorious for its sharp sales practices and eye-watering prices, so for all Apple’s own notoriety the news might actually represent a leap forward for consumers in that sector. We have to ask though, if Apple of all people are now the Good Guys, where has the world of electronics gone so badly wrong?

Your grandparents decades ago would have had a simple analogue hearing aid if they had one, usually a small transistor circuit and perhaps with some kind of analogue filtering. Digital aids with DSP algorithms to pick out speech arrived some time in the 1990s, and from there evolved a market in which their high prices increasingly didn’t match the cost of the technology or software involved. At least in the UK, they were sold aggressively to older people as less cumbersome or better than the National Health Service aids, and if you had an older person in the family it was routine to see pages and pages of targeted junk mail offering dubious financial schemes to pay for them.

The question then, given that a modern hearing aid has a relatively cheap microcontroller and DSP at its heart, why has the open source community not risen to the challenge? The answer is that they have, though the Tympan seems an over-expensive trinket for what it is and the LoCHAid and Open Speech Platform seem to have sunk without trace. Can we do better?

Header: Gregory Varnum, CC BY-SA 4.0 .

Software Bug Results In Insulin Pump Injuries, Spurs Recall

May 11, 2024 by Dan Maloney 24 Comments

Managing Type 1 diabetes is a high-stakes balancing act — too much or too little insulin is a bad thing, resulting in blood glucose levels that deviate from a narrow range with potentially dire consequences on either side. Many diabetics choose to use an insulin pump to make managing all this easier, but as a recent recall of insulin pump software by the US Food and Drug Administration shows, technology isn’t foolproof.

Thankfully, the recall is very narrow in scope. It’s targeted at users of the Tandem t:slim X2 insulin pump, and specifically the companion application running on iOS devices. The mobile app is intended to run on the user’s phone to monitor and control the pump. The pump itself is a small, rechargeable device that users often keep on their belt or tucked into a pocket that delivers a slow, steady infusion of insulin during the day, plus larger bolus doses to compensate for meals.

But version 2.7 of the t:connect mobile app can crash unexpectedly, and on iOS devices, that can lead to the OS continually relaunching it. Each time it does this, the app tries to reconnect with the pump via Bluetooth, which eventually runs down the battery in the pump. Once the battery is dead, no more insulin can be delivered, potentially leading to a condition called hyperglycemia (“hyper” meaning an excess, “gly” referring to sugar, and “emia” meaning presence in blood — excess sugar in the blood.)

Untreated hyperglycemia can progress to a much more serious state called diabetic ketoacidosis, which can lead to coma and death. Thankfully, nobody has suffered that fate from this bug, but the FDA has received over 200 reports of injuries, hence the recall. Tandem sent out a notice to all affected customers back in March to update their apps, but it’s still possible that some users didn’t get the message.

Apart from the human cost of this bug, there’s a lesson here about software design and unintended consequences. While it intuitively seems like a great idea to automatically relaunch a crashed app, especially one with a critical life-safety function, in hindsight, the better course might have been to just go into a safe mode and alert the user with an alarm. That’s a lesson we’ve learned by exploring space, and it seems to apply here as well.

Images: AdobeStock, Tandem Diabetes

FDA Approves Ventilator Designed By NASA’s Jet Propulsion Laboratory

May 1, 2020 by Mike Szczys 28 Comments

Yesterday NASA’s Jet Propulsion Laboratory announced that their ventilator design has received Emergency Use Authorization from the US Food and Drug Administration. This paves the way for the design to be manufactured for use in the treatment of COVID-19 patients.

JPL, which is tightly partnered with the California Institute of Technology, designed the ventilator for rapid manufacturing to meet the current need for respiratory tools made scarce by the pandemic. The design process took only 37 days and was submitted for FDA approval around April 23rd. They call it VITAL — Ventilator Intervention Technology Accessible Locally — a nod to NASA’s proclivity for acronyms.

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The Strain Of Flu Shot Logistics

November 26, 2019 by Kristina Panos 43 Comments

Did you get a flu shot this year? How about last year? In a world of next-day delivery and instant downloads, making the yearly pilgrimage to the doctor or the minute clinic feels like an outdated concept. Even if you get your shots free at the office, it’s still a pain to have to get vaccinated every year.

Unfortunately, there’s really no other way to deal with the annual threat of influenza. There’s no single vaccine for the flu because there are multiple strains that are always mutating. Unlike other viruses with one-and-done vaccinations, influenza is a moving target. Developing, producing, and distributing millions of vaccines every year is a massive operation that never stops, or even slows down a little bit. It’s basically Santa Claus territory — if Santa Claus delivered us all from mass epidemics.

The numbers are staggering. For the 2018-19 season, as in last year, there were 169.1 million doses distributed in the United States, up from 155.3 million doses the year before. How do they do it? We’re gonna roll up our sleeves and take a stab at it.

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Homebrew Pancreas Gets 30 Minutes Of Fame

August 9, 2018 by Al Williams 25 Comments

It is pretty unusual to be reading Bloomberg Businessweek and see an article with the main picture featuring a purple PCB (the picture above, in fact). But that’s just what we saw this morning. The story is about an open source modification to an insulin pump known as the RileyLink. This takes advantage of older Medtronic brand insulin pumps and allows you to control the BLE device from a smartphone remotely and use more sophisticated software to control blood sugar levels.

Of course, the FDA isn’t involved. If they were, the electronics would cost $7,000 instead of $250 — although, in fairness, that $250 doesn’t cover the cost of the used pump. Why it has to be a used pump is a rather interesting story. The only reason the RileyLink is possible is due to a security flaw and an active hacker community.

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Making The Case For Open Source Medical Devices

January 30, 2018 by Mike Szczys 53 Comments

Engineering for medical, automotive, and aerospace is highly regulated. It’s not difficult to see why: lives are often at stake when devices in these fields fail. The cost of certifying and working within established regulations is not insignificant and this is likely the main reason we don’t see a lot of work on Open Hardware in these areas.

Ashwin K. Whitchurch wants to change this and see the introduction of simple but important Open Source medical devices for those who will benefit the most from them. His talk at the Hackaday Superconference explores the possible benefits of Open Medical devices and the challenges that need to be solved for success.

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3D Prints And Food

October 17, 2017 by Al Williams 55 Comments

We recently ran a post about a cute little 3D printed elephant that could dispense booze. The design didn’t actually have the plastic touching the liquid — there was a silicone tube carrying the shots. However, it did spark a conversation at the secret Hackaday bunker about how safe it is to use 3D printed objects for food. In particular, when I say 3D printing, I’m talking fused deposition modeling. Yes, there are other technologies, but most of us are printing using filament laid out in layers with a hot nozzle.

There’s a common idea that ABS is bad in general, but that PET and PLA are no problem because there are food-safe versions of those plastics available. However, the plastic is only a small part of the total food safety picture. Let me be clear: I am not a medical professional and although my computers have run a few plastics plants in years past, I am not really an expert on polymer chemistry, either. However, I don’t use 3D printed materials to hold or handle food and while you might not drop dead if you do, you might want to reconsider.

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