Common misconceptions about OTC hearing aids

More food for thought, found on my LinkedIn feed.

In my LinkedIn feed, I recently saw a few comments suggesting the newly introduced Bose SoundControl and Signia Active Pro hearing aids are overpriced.

But both of those products are priced well below the “average price” for traditional hearing aid offerings. Why are they then perceived as “expensive”? What stands behind this seeming paradox?

In both cases, the product was perceived as expensive - because it diverged from the common understanding of a traditional hearing aid. It was different! - It seemed that the primary expectation from a novel, different hearing aid is lower price. The possibility that novel product could also be better, instead only cheaper, - or maybe cheaper and better at the same time - is all but ignored.

Selective Assumptions and Hidden Expectations

The discussion that developed as a reaction to the advent of the OTC hearing aid category involves several fallacies. This is understandable since every argument is a part of a broader agenda: pro or against OTC, pro or against traditional hearing aids. Unfortunately this curbs the discussion.

Here are some of the misinterpretations:

Incorrect Assumption #1: Traditional hearing aids are safe and effective because they are subject to FDA regulation.

This is not necessarily true. The majority of hearing aids are exempt from FDA’s premarket notification and most of their features are not subject to safety approvals .

Not all FDA-regulated hearing aids are of equal quality : some of them are carefully designed and manufactured, some others struggle in copying the leaders, some of them are quite bad - which means that the judgment about safety and efficacy is partly left to the market. The value of non-regulated features and the value of the product quality is determined only by the market.

This " freedom from regulation " that traditionalists assume acceptable in case of traditional HAs is at the same time their main complaint blamed on OTC.

Incorrect Assumption #2: The current price of traditional hearing aids is a valid benchmark for OTC hearing aids.

Price tags of traditional hearing aids have not changed much in 10 years. But even on the wholesale level, the price stability is less an effect of the underlying cost of technology than it is an effect of the immutable distribution model.

Both the benefit and the price of a traditional hearing aid are driven by the fitting-service. OTC devices can be compared with them only if their benefit is proven equivalent. This might be claimed in some cases (of mild hearing loss), but even then it is inadequate to benchmark the price of OTC devices against the now-famous 6k US$, assigned to a pair of premium traditional hearing aids. If OTC HAs one day provide equivalent benefits as the professional channel, there will be no need to benchmark against it.

Also, not all product-levels provide the same value. I was amused to read a claim by a company that distributes not-so-premium OEM hearing aids directly-to-consumer that they “have shaved 80% off the hearing aid price”. Their reference was the famous 6k US$! Same as if Toyota Corolla would claim saving you 80% price of a Rolls Royce vehicle.

Incorrect Assumption #3: Self-fitting doesn’t work, otherwise, the large manufacturers would have introduced it.

Actually, the large manufacturers do believe in the self-fitting use case. They only do not see the related business case. Not yet.

Traditional hearing aids include many self-fitting features: In-situ audiometry is a part of hearing aids for many years, providing the full toolbox for diagnostics within the hearing aid. (Why such HAs were never regulated under FDA class II category “Audiometer”?) Some hearing aid apps are already allowing the user to correct multidimensional parameters of prescribed amplification in her hearing aid according to her listening preference - without any involvement of the professional practitioner… Self-fitting in action!

Large hearing aid companies are making another important move towards Self-fitting products: they are withholding the purchase decision from healthcare professionals and advertizing directly to the patients: by introducing fashionable and lifestyle lines of products and by licensing brands widely known outside of professional community. Once the patients make their own purchase decisions, they might be ready to take ownership in controlling/fitting their Philips, Bose or Sennheiser devices.

Incorrect Assumption #4: Big hearing aid manufacturers have a technological advance and specific know-how, that is out-of-reach for newcomers

Some comments belittle Bose’s self-fitting hearing aid, comparing unfavorably to an entry-level product by Widex (which is slightly more expensive but includes fitting service).

This assumption (that incumbent products are more credible than newcomers) doesn’t have to be true: for targeted mild-to-moderate hearing-loss, users’ sound preference might be more suitable than precision-fitting - and Bose has a reputation for designing high-quality audio products. So it can be just as well claimed, that Bose device is relatively underpriced.

Some hearing technologies, such as spatial hearing, de-noising and acoustic source separation, are rapidly advancing outside of hearing healthcare. Resolving hearing problem traditionally through loudness restoration is only one approach - signal augmentation is another way. It is likely that the big hearing aid manufacturers are technologically lagging in this respect.

Incorrect Assumption #5: OTC is essentially about fraud, traditional hearing aids are honest products.

Indeed, the emerging OTC/DTC marketplace sometimes resembles a lawless gold rush . It is not clear where the serious competition ends and where the gray market begins. The competitive advantage is often solely a suspiciously low price.

For that reason, it is now urgent that OTC hearing-aid category becomes regulated. - In order to increase the quality of the OTC products (and protect potential buyers). It would be great if the energy of the gold rush soon fuels a technological innovation race .

On the other side, the traditional hearing aid industry itself was not always free of dubious propositions . The second-tier manufacturers, lacking tangible innovation (using same off-the-shelf audio-processing components) and with limited audiology and marketing skills, they traditionally rationalize their prices by incrementing a single spec, usually the number of WDRC channels. This approach is not driven by audiological reasoning, but it is very handy as a competitive comparison. (To my knowledge, the products claiming 128 channels and “no channels” are currently leading this spec-war).

And among the more serious crowd of the top-tier , creative marketing speak produces sometimes very juicy benefit claims - unusual for the dry conventions from the realm of medical devices. I also guess that in-house researchers are not very surprised when in a clinical trial their own product easily outperforms the competitors A, B and C! This happens so frequently, that such scientific publications in the meanwhile carry almost no information and are indistinguishable from marketing brochures.

Doesn’t have to be a Zero-sum game

The discussion about OTC is today unnecessarily ideological - the answer is known before the question. Which is a pity. The OTC proponents complain only about high price, the traditionalists claim (without proof, even without trying) that no technology can replace current distribution-model.

Most of the “affordable” OTC/DTC offerings would be perceived as extremely expensive by consumer-electronics standards, if the famous 6k US$ benchmark would not be there. By skipping the fitting service, it is not a big feat to underprice that figure several times.

But the defensive assumption that self-fitting OTC HAs can be price-competitive only through reducing the benefit below an acceptable level is also not valid: The current distribution-and-fitting paradigm is established long before the technological advances that have ushered digital health, platform-economy, and extensive changes in human communications. Building on technology, an OTC device with superior price/performance ratio is very likely to appear soon.

From that point of view, it is only plausible to project that OTC HAs will accelerate the hearing healthcare technology, increase user benefits - and eventually rejuvenate the whole industry.

Source: What we talk about when we talk about OTC hearing aids...


The Congressional Act was motivated in bringing costs down so many more could obtain hearing assistance that is beyond their means (big applause from me. I am a fan of the principle). I believe all you misconceptions are accurate and not always addressed in discussions about OTC aids.

My personal target to compare an OTC aid with a traditional aid is to the basic level and basic performance among prescription aids that are professionally fitted. That price has come down quite a bit over the last several years. Thanks to my reading here, you can get a very capable device that exceeds a basic level of performance and features, with fitting, for $1,400 at Costco. I think it’s more appropriate to use that for comparison.

If that’s your basis for a side by side look of OTC vs. RX, then I believe a 50% savings, or more, would make them attractive to the mass market who can’t go over that magic four number barrier of $1,000.

I think Bose is a little too close in pricing at $849. If your goal is to really reach the large number of folks for whom RX HAs are out of reach, a price point of $500-700 would be more appealing. The goal of the legislation was to significantly lower costs for those with fewer means. I would like to see the market drive those prices lower for greater market acceptance.

As to the Wild West we already have with aids sold online, the FDA needs to be able to start holding them responsible for fulfilling performance guidelines. Unfortunately, without a final set of rules, there’s nothing to enforce and some will continue to abuse the market with sketchy claims and substandard products.


I’m probably one of the ones that thought the Bose OTC hearing aids were too expensive at ~$800. Factoring into my bias is that Bose has never been known for offering bargain prices. Although it is notably less expensive than Costco’s KS10 at $1400, the value just doesn’t seem there TO ME. There’s no service. Although warranty wasn’t specified, I’m guessing it’s a year versus Costco’s 3-5 years. It’s not hard to imagine costs for supplies and repairs exceeding $1400 over 3-5 years. For all but the diligent Do it yourselfer, I think having a human resource that one can go to for help is valuable.


The other perspective is the opportunity to take something like AirPods Pro with noise cancellation, get a decent directional mic so it’s going to enhance the speech of someone facing you, and you’ve improved the quality of life for a larger number of older people for under $400. That’s value. You can have some very basic enhancements in there as well, but it’s not be a great solution for a multiple person conversation in a noisy restaurant, but the price is right and the most basic of features are there ( and let’s face it, any HA struggles in that environment short if maybe a top end premium HA, which is also $6-7K).


The real question is “are they good enough?” for the majority of potential users without unusual or severe hearing deficiencies.

Only then can the cost and hence value to the individual can be assessed properly over say 3 to five years.

At the rate of technical change it may be better to start using these cheaper OTC aids and almost regard them as “disposable” and replace them with better, newer models every year or so.

This might work for many people (near the center of the bell curve) - but not those with more difficult hearing problems.


This is a pretty fair and balanced review by an audiologist that details some of the pros and cons of OTC hearing aid devices vs lower cost alternatives (i.e. hearables): Nuheara IQBuds Max 2 Hearing Aid Review | IQBuds2 - YouTube

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