Levo Tinnitus System — It Works but at What Cost?

The Levo System is an FDA-cleared medical device created by Otoharmonics. This device is used to recreate the individual’s specific tinnitus sounds that they then listen to through custom earbuds.

This program happens while they sleep for a course of three months.

Otoharmonics claims that over time, the brain will learn to naturally ignore these sounds and aims to improve the individual’s quality of life.

Levo software allows the individual to listen to their personalized sound match on an Apple iPod touch. It’s unclear if this software is available on any other types of devices.

It’s also listed that Levo is for individuals who have “atonal” tinnitus, or tinnitus that is very high or very low in pitch (<200Hz or >10000Hz).

This method of tinnitus relief is unique as it focuses on treatment during sleep and works to retrain the brain to ignore the individual’s tinnitus sounds. Otoharmonics also claims that the custom-fit earbuds are critical to the success of the program so the patient can get the most from this sound therapy treatment.

So for those who suffer from tinnitus, they can complete treatment during the night without interrupting their daily life. However, it’s unclear how easy it is to sleep with this patented nightly sound therapy. Otoharmonics also claims that they utilize a “neuroscience-based approach” in their nightly sound therapy designed for treating tinnitus. Although, their website doesn’t seem to have any research or studies for patients to read up on. There are a few mentions of research, but doesn’t include specific studies.

Does Levo Reduce Tinnitus?

If you do some of your own research online, you may find a recent study on the impact of reduction of tinnitus symptoms on the individual’s quality of life.

Twelve people with chronic tinnitus were chosen for this 3-month study. Each patient was given a customized sound that reproduced their personal tinnitus sounds. This stimulus was uploaded into a device and played through customized earbuds during sleep. After three months, the study found that “the intensity reduction achieved through the protocol used in this study had a direct impact on the improvement in the patients’ quality of life.”

Although not much is known about tinnitus, it’s widely agreed that whatever tinnitus treatment is used, is that the system needs to be a personal approach to the individual’s tinnitus needs. “One size fits all” does not seem to be effective for reducing tinnitus. It’s also difficult to pinpoint the perfect treatment when there are so many different causes of tinnitus.

Levo Tinnitus vs Traditional Tinnitus Masker

The National Center for Rehabilitative Auditory Research at the VA Portland Health Care System released a study in 2017 comparing the Levo Tinnitus System versus a traditional tinnitus masker. Their aim was to “determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus.”

They used tinnitus-matched (Levo System with Sound Match), noise stimulus (Levo System without a match), and a traditional bedside sound generator methods to compare results. They found, through this randomized study, that the Levo System Sound Mask showed better tinnitus reduction than the traditional masker.

“We are at least 87% certain that treatment with tinnitus-matched or noise stimulus reduces mean Tinnitus Functional Index compared to treatment with bedside sound generator,” the study concluded. “We are at least 95% certain that treatment with tinnitus-matched results in greater reduction in mean numeric rating scale of tinnitus loudness compared to the other groups.”

Although it is only one study, it shows potential for devices like the Levo Tinnitus System. However it’s important to note that both in-ear devices used in the study were Levo System products and the study was funded by Baker Group LLP, which manufactures Levo System devices.

Levo Tinnitus Reviews

Because this product is not sold on places like Amazon or eBay, it’s hard to find genuine reviews of the Levo Tinnitus Systems. Of course, there are some testimonials on the Otoharmonics website, but it’s only positive reviews (as one would expect).

But is sound therapy designed to improve tinnitus symptoms actually working for its customers? It’s hard to say.

Some comments on articles about Levo include:

I purchased the Levo system one month ago from an audiologist. The cost was $4,500. Insurance does not cover it. I have worn it every night since and there is no difference yet. I was told that it will take 90 days for Neuroplasticity to work. Which they tell me means, that once the brain retrains itself it will ignore the ringing.

I also received mixed information on what happens if it does not work after 90 days. The audiologist said I could get a refund minus a charge of around $500. But, when I met with the rep from the manufacturer I was told there is only a refund within 30 days if there is a problem with the iPod or software. If after 90 days it does not work, then basically too bad, no refund.

Paul

I went to Levo System because it was FDA approved. They gave me a hearing test and I was mildly impaired. They rejected because I had not had tinnitus long enough and I could not identify a consistent sound.

Forum post

How much does Levo Tinnitus System cost?

It’s hard to find definitively how much the Levo Tinnitus System costs in the US, but one user noted that it’s around £4,500, $7,500 CDN or $5,700 USD.

The Tinnitus Clinic in the UK has noted that the Levo System with Universal earbuds is £3,999 including VAT. It also says that “there is a 2-week comfort testing period during which the Levo System can be returned. In the event of a return, The Tinnitus Clinic retains £500 to cover the fitting and return of the device to the manufacturer. Should you select custom build earphones at any time, these costs £500 including VAT. This includes the taking of moulds and a short fitting session at your local clinic.”

For such an expensive program, it’s incredibly important to read the fine-print in terms of how much it will cost and what your refund options are if the program doesn’t work for you.

Of course, these prices will most likely include a meeting with a hearing professional to choose the right pitch and frequency for the individual, as well as getting fitted for custom earbuds.

Yes, this is a personal and patented nightly sound therapy designed to improve the quality of your daily life. However, the sheer cost is going to be the biggest downside of this sound therapy treatment. Few tinnitus sufferers will be able to afford such an expensive treatment, especially if there are concerns about refunds and returns as mentioned by Paul’s comment.

Conclusion

This is the first tinnitus treatment option that isn’t overwhelmed with red flags, like Tinnitus 911, Tonaki Tinnitus Protocol and Silence Complete. There is some real science behind this FDA cleared neuroscience based system, and sound therapy in general for tinnitus treatment.

However, the biggest downside for this tinnitus treatment is the cost. Although there are various prices listed online, it looks like on average you may be looking at a bill of about $5,000 USD. For many, this is simply unrealistic, especially for a treatment that may not work for their personal symptoms.

It would also be beneficial to hear more balanced reviews on the program, rather than just positive testimonials sent out by the manufacturer.

Effectiveness50
Ingredients0
Value20
Positives
Real science behind sound therapy
Legitimate company
Negatives
Huge price tag
No full refund if it doesn't work
50
Potential but expensive
There is some solid science behind Levo, but it comes at a huge cost. It would be great to see a more accessible option on the market in the future

Quiet Mind is a blog dedicated to turning a critical eye to tinnitus treatments and supplements.  So many don’t work and are overhyped, we’re here to shed some light on some of the scams and successful products that claim to stop the ringing.

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