Here is the story of OTC (Self Fitting) Hearing Aids

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. Today, five or maybe six Multinational companies produce over 95% of all hearing aids sold worldwide1These 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”.  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 or need. 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”. Costco led the “unbundling” of MD  and hearing specialists.  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 with unbundled services.  Costco offers the lowest prices for quality “prescription” hearing aids. (Costco’s Kirkland brand 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 – noise-cancelling. 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 Headphones 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 antenna of Apple 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, Prescription hearing aids that have been sold have been deemed no longer necessary.  This is for  mild and moderate hearing loss. Severe hearing loss must still be treated as a medical  condition.

 OTC Hearing aids can replace the hearing aids that were previously prescription only.

Previous prices were tiered based upon perceived Technology Level not size or style. OTC technology has caught up to high end Hearing aids technology-wise.

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. Some plans pay for one 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 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

Medicare in general does not pay for hearing aids for those over 21. In some states—very few, it pays limited costs.

Legislation

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 their sail.

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.$85 hearing aids

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 eye 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 masking², enhanced high range/low range, rechargeable batteries, etc.

Styles of hearing aids: These are all offered as OTC:

• 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 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 replacing batteries every three days.

Currently, OTC earbuds and AirPods only have a 4-hour usage, but can quickly be recharged in their case .  The occasional user finds that this works for their most of their needs.

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 onto for many years. The average life for even the best 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.

REGULATIONS (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 decibels. Ambulance siren: 112 decibels (it is hard for me to believe that the volume 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 physically  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 undergone a 510(k) submission, which FDA has reviewed and provided clearance. Got that? Bottom line is that if you can state that someone has already gotten clearance for what you do, you don’t necessarily need to have specific clearance.

Everyone now is calling their devices Hearing a Aid whether Cleared or not!

The first cleared self-fitting OTC hearing aid 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. See my post about Apple Don’t shade me – I’m Hard of Hearing – Apple Ashamed?

The Sony model CR11e is my favorite OTC hearing aid bud out there at this time. – $1,200.

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.  see my post OTC hearing aids Disruptive

To date nothing has happened

However, everyone is coming down in pricing slightly to the Costco pricing level and introducing their existing devices – re-branded with American marketing companies like Sony/WS.

OTC 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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1. https://www.statista.com/statistics/1087388/global-hearing-aid-market-share-by-company/ ↩
2. https://hearinghealthmatters.org/hearing-news-watch/2016/hearing-device-brands-mapped-hearing-tracker-1001/
3. Tinnitus masking is a way of training your brain into just pushing your noises from tinnitus into the background—not eliminating them. ↩