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Now new technology and a rare bipartisan push from lawmakers who are trying to reduce regulations for the sale of hearing aids are raising hopes that more people with mild to moderate hearing loss will be able to buy hearing devices a lot more cheaply and without seeing a doctor.
It's a modest-sounding goal, but supporters believe the measure on Capitol Hill could lower prices, spur innovation, and ultimately get hearing aids into the ears of far more people. Only 15 to 30 percent of people who need hearing aids actually get them, according to some estimates.
Currently, regulations in most states, including Massachusetts, require consumers to go to a licensed audiologist or other specialist to purchase a hearing aid. The average cost: $2,300 per ear.
Legislation sponsored by Democratic Massachusetts Senator Elizabeth Warren and Republican Senator Chuck Grassley of Iowa would supersede individual state rules and force over-the-counter hearing aids into the national market. It has the support of AARP, which is the largest lobbying group for seniors and advocates for people with hearing loss. But it is drawing opposition from hearing aid makers and a major trade association for audiologists.
Supporters say the bill could unleash competition and put hearing aids that cost a few hundred dollars on the shelves. It could also foster technology that, among other benefits, allows consumers to use smartphones to control their hearing aids.
(Score: 2) by epitaxial on Thursday April 13 2017, @09:13PM (3 children)
Hearing aids are classified as a "medical device" so that means you add an extra zero or two onto the price. Good hearing aids require a bit of tuning. The doctor will generate a curve based on the frequency and severity of the loss. Program in that filter and you're done.
(Score: 2) by Grishnakh on Thursday April 13 2017, @09:26PM (2 children)
Sounds like there's a business opportunity here: sell (relatively) inexpensive but nice Chinese-made hearing aids with this tuning ability, and let buyers use a software program to test their hearing themselves and program the hearing aids at home.
(Score: 0) by Anonymous Coward on Friday April 14 2017, @01:23AM (1 child)
Yeah, but if you do that in the US, either the FDA will shut you down for offering unlicensed medical devices, or you'll have to go through a lengthy and expensive process to get the combination of hardware and software approved as a medical device, and it will no longer be cheap. If you do it outside the US, but shipping to the US, you may escape, but customs will soon start seizing your packages, and you'll go out of business anyway.
You can sell audio amplifiers for healthy people to eavesdrop on distant songbirds, but if you make them with tunable filtering, and supply software to test hearing loss, they're going to call it a medical device, no matter how many songbirds you draw on the packaging. While ordinary hearing aids are laxly regulated, as medical devices go, I'm pretty sure incorporating the diagnosis capability (regardless whether it's in the device proper, a separately downloadable android app, or whatever) is going to get you out of that class.
(Score: 2) by kaszz on Friday April 14 2017, @02:14AM
Package it as a "fun audio amplifier that makes people sound funny". Then let some hacks leak.. (to adjust the DSP for a frequency curve)
Alternatively have it sent to Mexico and pick it up there?