OVER THE COUNTER
You have heard a lot about self-fitting hearing aids – here is the story
While hearing devices have been around for the millennium, ie hearing horns, only in the last century have they become objects of commerce.
Led by, (for some reason or other) several large Nordic companies, five Multinational companies produce over 95% of all hearing aids sold worldwide https://www.statista.com/statistics/1087388/global-hearing-aid-market-share-by-company/These companies along with Health Care Professionals have had a monopoly on the worldwide market that is unprecedented.
A $15 billion industry.
Under hundreds of different brand names, these hearing aids were sold “prescription only” and at pricing levels $2,500-$18,000. Common thought is that these are sold on a 4x (or more) markup. This pricing level restricted the use of the hearing devices by pricing them to the level beyond the reach of what people were willing to pay for the convenience. This level would make hearing aids the third priciest common purchase behind a house and a car.
Costco entered the market five years ago and disrupted the pricing structure – now selling 11% of all hearing aids (increasing 20% per year). Costco’s product are produced by all the big 5 and blurred the lines of “prescription”- providing light professional care. Costco hearing aids cost about $1,400. Prices have been coming down, with now a two-tiered system of Medical Doctors and Audiologists still having the “high” ground and pricing, and large retail outlets like Costco covering the lower end. Costco offers the lowest prices for quality “prescription” hearing aids, and manufactured by all of the big five. FDA says over 800 different hearing aids are in the marketplace. (Costco’s Kirkland brand, made by WS, have recently been pulled off the shelves because of battery recharging issues)
Technology
OTC (self fitting) became inevitable because of technology-not government largess! Popular headphones and earphones developed “noise cancellation” which provided an exterior microphone that picked up outside sounds. Eureka! Once these outside sounds were brought into the device, software, and algorithms were used to modify them to amplify certain tones. It was discovered that Head-phones and Earphones could hear! Apple, Bose, and Google have been using their devices in the “Transparency Mode” and “sound amplifier” for over three years but have not marketed them as “hearing aids” because they were running under the radar of the FDA regulations. (by the way the external sound collection was developed in conjunction with the Big five’s engineering and patents). These devices are under $250!
Legislation
Legislation was started in 2017 (before the pandemic) by the Trump administration, which called for the FDA to take steps allowing hearing aids over the counter. Congress passed a bipartisan legislation requiring the FDA to create a category of OTC hearing aids by 2019. This was recently implemented as a final rule by the Biden administration, effective October 27, 2022. One might wonder if the five-year delay was due to heavy money and lobbying by the big five makers and the medical/audio complex. But the new law is seen as a promise for “expanding access to high-quality health care and lowering health care costs for the American public, while fostering innovation and competition in the hearing aid technology marketplace.Basically, the prescription hearing aids that have been sold have been deemed no longer necessary for mild and moderate hearing loss.
80% of all hearing aids sold can be replaced by OTC hearing aids without Medical supervision. Profound hearing loss still needs Medical help.
Previous prices were tiered based upon perceived technology level not size or style, and the bundling of medical practices. OTC technology has caught up to high-end Hearing Aids. This legislation had unbundled the device from the medical establishment.
Medicare
At this time, Medicare parts A & B do not cover any part of the Hearing Aid process—Audiologist, MD, or the actual hearing aid. Most plans pay for one Audiologist test per year. Medicare Advantage plans can cover, but there are over 4,000 plans that range from full coverage to no coverage.
Trying to find an agnostic insurance agent for health care is difficult! Come to think of it—I have not bothered to check my Blue Cross Blue Shield coverage! – now after three hours of checking, I still cannot decipher whether my BCBS Support-plan F covers hearing. The website did refer me to “True Hearing”, which would sell me hearing aids for as little as $2,642. I would surmise my plan does not cover hearing.
Medicaid
Medicaid in general does not pay for hearing aids for those over 21. In some states—very few, it pays limited costs.
Clawing back profits
The only way the existing Prescription Hearing market will survive is if Congress passes a bill allowing MEDICAID/MEDICARE to pay for prescription services and the higher priced Hearing aids they sell. Oh, what a surprise that the bill has been introduced and passed by the House. The Senate did not pass it, but there is too much money behind the scenes pushing this! What it will do is allow the two-tier pricing to continue and keep overall pricing high—to the benefit of the MEDICAL COMPLEX and the High-end hearing aids. Never bet against technology and change, OR the 5 manufactures of hearing aids worth billions of dollars. But if you can have the government pay most of the cost of prescription hearing aids, then OTC hearing aids will have some wind cut out of OTC’s sail.
Pricing disrupted
Pricing now being disrupted, there have been a multitude of “hearing devices“ hit the market. These were not allowed to be called Hearing Aids because the FDA had not approved them, they were not provided through the prescription Medical Complex.. Again, almost all of these devices were “down-specked” , manufactured in China and sold almost entirely online. Pricing for these devices are now under $1,000 and as low as $85. Some of these devices are Eargo, Olive, Lively(just merged with Jabra), Audicus, Hear.com , MDHearing, Audien Oticon, MiracleEar and Bossa ($85). The difference is low tech vs high tech.
What do OTC hearing aids do?
AMPLIFY SOUNDS. Hearing aids are not magic they just make tones louder so you can hear them better. (They do refine the sounds and amplify them according to the algorithm in the chip – reduce background noise, increase volume to the higher pitches etc. ), but their basic job is to amplify.
Even the very best hearing aids fitted by the best Audiologist and MDs do not bring back hearing to the normal level. This is unlike glasses that can bring your vision back to 20×20.
Of course some hearing aids and devices are a lot better than others. Years of engineering and research have gone into providing bells and whistles—background noise reduction, directional hearing, bluetooth pairing, tinnitus masking , enhanced high range/low range, rechargeable batteries, etc.
Styles of hearing aids:
- BTE(behind the Ear)
- in-the-canal (ITC)
- Completely in the canal (CITC)
- in-the-ear (ITE)
- receiver-in-canal (RIC)
- Open Ear
- Ear Bud
Battery Life
Until recently, all hearing aids needed a battery change about every three days. These C10 batteries are relatively cheap but difficult for the elderly to change—another reason they are not used. However, with technology catching up, the newer models (also more expensive) are rechargeable and are 100x more practical than re-placing batteries every three days. The high-end rechargeable aids have the following characteristics;
– used for 3-8 hours straight in ear, then have to put back in case to recharge.
– 3 hours to fully charge
– 30-minute charge for 8 hours of use
– 30 hours total battery life when fully-charged (don’t break fooled by this- this means that when your aids loose charge, you then put them back in the case and they recharge there, so you use them for say four hours, put them in the case. The case charges them for 30 minutes and then the case has 24 hours of charge left. Currently, earbuds and AirPods only have a 4-hour usage, but can quickly be re-charged in their case .
Most new OTC products are sold as rechargeable, but with differing charged lives. Currently, the smaller the device, the less battery life. If your plan is to wear the hearing aid 14 hours a day, there are very few rechargeable OTC devices that can last that long.
No rechargeable battery lasts forever, so you are going to have to think about replacing your device device every 3-4 years . At a lower price point and the way technology is changing the business, replacement is not all bad. Wear and tear, dirt, earwax, water, and loss, make hearing aids a product that most people don’t hang on to for many years. The average life for even the best prescription in-the-ear hearing aid is said to be 3-4 years, with the behind-the-ear models lasting longer but not much. That means that if someone starts wearing hearing aids when they are 70 and live to be 90, they will spend over $20,000 on the devices alone! Time for change.
WILD WILD WEST
No one believes that the FDA intends to enforce the new regulations stringently. Either the regulations are soft or there is really nothing to making Hearing Aids for the masses.
FTC Requirements: (incredibly easy!)
– Maximum volume the devices are allowed to output to 111 db – the equivalent sound to a power lawn mower) Car horn: 110 decibels. Nightclub: 110 deci-bels. Ambulance siren: 112 decibels (it is hard for me to believe that the vol-ume allowed is above the threshold that can cause damage over prolonged use: Noise above 70 dB over a prolonged period of time may start to damage your hearing. Loud noise above 120 dB can cause immediate harm to your ears.
– must meet certain device performance and design requirements that include limits on sound distortion, delay, and range of output frequencies.
– Limits on how far the hearing aid can go into the ear canal to prevent injury and
– Sets labeling requirements to ensure consumers know the limitations of their device and how to report adverse events.
– Regulations also said that marketers also have to spell out clearly the return policy – they cowered out of stating how long you have (as a “free trial”- return policy) short is 45 days, and long for 90-120 days.
“Self-fitting” OTC hearing aids will require 510(k) clearance, while other OTC hearing aids will not. Clearance: When a medical device is cleared, this means it has under-gone a 510(k) submission, which FDA has reviewed and provided clearance.
Everyone now is calling their devices a Hearing Aid whether Cleared or not!
The first cleared self-fitting OTC hearing aid cleared was the Sony CR10 . Sony re-branded a current WS model —one of the Big 5 manufactures who already had an identical model for sale in the UK – Signia. So much for innovation
Right now (soon after the roll out) it looks like business as usual with the Big Five buying out US marketing brands like Sony Bose, HP, and, Jabra. There has been no stimulating innovation nor significantly lower prices. The higher quality OTC devices will be selling around $1,000, not $250 where the AirPods are. Apple could break this? I hope so. Prices should and need to be in the $250 range to really have an impact on the industry.
But I doubt even Apple can break the monopoly of the Big Five.
To date nothing has happened
However, everyone is coming down in pricing slightly to the Costco pricing level. the big five introducing their existing devices – re-branded with American marketing companies like Sony/WS.
OTC promises will be real when pricing comes down to AirPod Pro’s pricing, quality, and benefits at $250. At that price, you could afford to lose them, get them wet, upgrade them the next time a better comes around, and just see how much you like them and how they make your Everyday Life Better.
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