Otoharmonics (The Levo® Therapy System for Tinnitus)

A new sound therapy called Otoharmonics is being introduced in the U.S. The company is located in Portland, Oregon, but, I believe also has its origin in Uruguay. The therapy utilizes an iPod and an ear piece. An audiologist matches your tinnitus tone, inputs it into an iPod, and you listen to that tone every night while you sleep.

In 2010, the International Tinnitus Journal (ITJ) published a pilot study that I believe was the basis for the Otoharmonics device. The article may be accessed by clicking here.

Here is the abstract from the study:

A new strategy for idiopathic subjective tinnitus treatment - sound stimulation during sleep - has been applied. It was based on the knowledgement that the auditory system also works during sleep, processing the incoming information. Eleven patients were stimulated every night during 6 months. The stimulus was a sound that mimetized the tinnitus and was fixed at the same tinnitus intensity, applied through an iPod. All patients decreased their tinnitus intensity in the first month of treatment (statistically significant), most of them in the first week. Tinnitus intensity continued decreasing in the following weeks; three patients presented periods of total silence.
​

This is the link to the company's webpage: http://otoharmonics.com/home

A 2012, YouTube video exists that explains the technology. I'm presuming the video is from a CNN channel in Uruguay.

CNN - Otoharmonics - Tinnitus

Finally, Otoharmonics is a corporate sponsor of the ATA. Here is their description:

The team at Otoharmonics – a group of world-class scientists, clinicians, business professionals and patients – has developed a new home therapy system to enable a comfortable and personalized method for managing tinnitus. Understanding that no two people are alike, our team harnessed advanced discoveries in neuroscience to develop a therapy that is uniquely tailored to the patient. No more one size fits all solutions. No more trying to drown out tinnitus with ambient noise. With a personal approach and a deep understanding of the impact tinnitus can have, the Levo System by Otoharmonics is designed to be user friendly and capable of delivering custom sound therapy that is based on the specific needs of each person.​

 

Sounds promising. And testable. If anyone can get an audiologist to record their t tone. However only tested on 11 patients?

 

Yes, the small number is disappointing. Nor did I see evidence of clinical trials except for the initial pilot study cited above. Though also subject to criticism, Neuromonics did perform several studies. See, for example, this one on the long-term effects of the treatment.

That said, no tinnitus treatment passes the strength of evidence (SOE) requirements to insure efficacy--according to a 2013 study conducted by the US Agency for Healthcare Research and Quality.

Why are treatments not adequately tested? The main factor is probably financial. Large scale clinical trials are quite costly. Without the backing of venture capital or the major pharmaceutical companies, most companies cannot afford to rigorously test their products. And so the public becomes the product testers.

But audiologists typically offer a free trial period. These periods range from one to several months. If anyone tries Otoharmonics, you must request a trial period--as long as possible--since unwinding the maladaptive neuroplasticity of tinnitus does take time.

I do hope people on TT try this therapy and report on it. This is the first therapy that utilizes sleep to induce neuroplastic changes. Perhaps, the inventors are onto something!

 

What if you have multiple tones?

 

I'm not sure. I have two tones and I've always wondered if any sound therapy would work for me. This is why you need a trial period. When I've read about multiple tones in other sound therapies, you are typically asked to match your dominant tone or the tone that bothers you the most. I believe you only work on quieting one tone at a time.

 

Yeah, I have little hope in all these sound therapy treatments that are based on "matching the tone". Before I got hyperacusis and TTS in november my regular T consisted of 2-3 sinus tones, one tone in the middle of the head, one that was in the ears and one that was super high pitched so I could barley hear it at all unless I clenched my jaw. Now I have tons of more tones, some of them are shifting in pitch too, like they don't know what pitch they should stay in, kinda wobbly tones. I can't see how it would even be possible to find the most dominant tone. But if it is as you think, that you do it one tone at a time, then it could possibly work, but take longer time.

 

I have multiple tones also. I hope they can not only match the pitch, but the actual quality of the tone also. My most annoying tone is a nasal motorized (revving engine) tone that moves a semi tone up and down.
Having said this, it is probably something that we could put together ourselves on any good sound engineering/recording system.
@jazz @Steve H

 

Nice paper, but I have two comments/questions :

1. Perhaps the decrease in tinnitus intensity was due to better sleep quality, induced by the generated sound (acting as a masker). In other words, perhaps a better study should have had a control group receiving a regular masking sound (e.g. white noise) during sleep, and compared it to the group receiving the tinnitus frequency matched sound.

2. The proposed mechanism of action of this technique seems to be :

• "The reduced spontaneous activity for nerve fibers with [frequencies] in the hearing loss range may result in a reduction of inhibition, mediated by the auditory efferent system, at more central levels4. This reduced inhibition of neurons with CFs induces hypersensitivity and hyperactivity in these neurons, generating a "phantom sensation"
  
• "Thus, it should be possible to reverse [this] by proper sound treatment taking advantages of the neural plasticity properties of the CNS."

In other words, if loss of neural input from hair cells for a certain frequency F causes tinnitus (via a compensatory mechanism, i.e. reduced inhibition, downstream), then inputting sound at that frequency may reverse this (supposedly by increasing inhibition downstream).

The obvious question here is how would inputting sound at frequency F help, if hair cells for F are already non functional and so have no neural output? I guess this question can be asked generally about all tinnitus frequency maskers - how can sound input (of any loudness) at a matched tinnitus frequency mask tinnitus, if tinnitus is caused by the inability to receive neural input at that frequency from the hair cells?

 

Great questions! I'd presume the "filling in" frequencies are compensating for lost or diminished input from the cochlea to the auditory parts of the brain, beginning with the DCN.

Several theories exist on how sound therapy may facilitate habituation. The "filling in" mechanism is one; "notch therapy" is another. The bottom line is that researchers don't know why some people get relief from sound therapy and others do not. I'm not sure about the percentage of people who are helped, but some studies suggest perhaps 50% of tinnitus sufferers do get relief from sound therapy--regardless of its exact mechanism of action.

Using sound therapy for sleep, however, is a new concept. It's interesting if this methodology would effect changes that differ from waking sound therapies.

 

Yes, agreed, Steve. I think if the exact tone and quality/texture is replicated, this could be a very good thing for residual inhibition. Also, while some people may think they have just one tone, it could be two tones together. For example, my nasal engine sound is often two tones sounding simultaneously, one half step apart.

 

Right, but if input from the cochlea to, say, the DCN, was truly lost for some specific frequency, then how would you be able to 'fill in' for it using any external sound generating device at that frequency? The cochlea simply would not be capable of transmitting any signal for that frequency.

Now it could be the case that the 'filling in' frequencies are not the exact frequency that was lost, but close to (surrounding) it. Perhaps that somehow 'tricks' the brain into thinking it is getting input from the lost frequency. I'm not sure I find this too plausible though, because regardless of the surrounding frequencies' amplitude, the input from the lost frequency remains at 0. And so if the tinnitus is caused by a neurological/biological mechanism due to a non existing tonal component (signal = 0), I don't see why it would be reversed.

It could also be the case that the effective frequency is able to be perceived, just in a diminished capacity. (Perhaps more than one hair cell is responsible for it, and some of these hair cells became dysfunctional while others remained intact. In that case, you can use the remaining ones to input the affected frequency at a higher loudness level.)

 

Yes, numerous studies talk about tinnitus filling in the "edge" frequencies of hearing loss--rather than tinnitus being a homeostatic adaption to one's maximum hearing loss. But I don't believe this. If there is "filling in," I believe it's in the hearing loss region.

Here is an interesting article that examines how tinnitus frequency is most likely determined:

Relationship between Audiometric Slope and Tinnitus Pitch in Tinnitus Patients: Insights into the Mechanisms of Tinnitus Generation

• Martin Schecklmann,
• Veronika Vielsmeier,
• Thomas Steffens,
• Michael Landgrebe,
• Berthold Langguth,
• Tobias Kleinjung mail
  

• Published: April 18, 2012
• DOI: 10.1371/journal.pone.0034878

Background
Different mechanisms have been proposed to be involved in tinnitus generation, among them reduced lateral inhibition and homeostatic plasticity. On a perceptual level these different mechanisms should be reflected by the relationship between the individual audiometric slope and the perceived tinnitus pitch. Whereas some studies found the tinnitus pitch corresponding to the maximum hearing loss, others stressed the relevance of the edge frequency. This study investigates the relationship between tinnitus pitch and audiometric slope in a large sample.

Methodology
This retrospective observational study analyzed 286 patients. The matched tinnitus pitch was compared to the frequency of maximum hearing loss and the edge of the audiogram (steepest hearing loss) by t-tests and correlation coefficients. These analyses were performed for the whole group and for sub-groups (uni- vs. bilateral (117 vs. 338 ears), pure-tone vs. narrow-band (340 vs. 115 ears), and low and high audiometric slope (114 vs. 113 ears)).

Findings
For the right ear, tinnitus pitch was in the same range and correlated significantly with the frequency of maximum hearing loss, but differed from and did not correlate with the edge frequency. For the left ear, similar results were found but the correlation between tinnitus pitch and maximum hearing loss did not reach significance. Sub-group analyses (bi- and unilateral, tinnitus character, slope steepness) revealed identical results except for the sub-group with high audiometric slope which revealed a higher frequency of maximum hearing loss as compared to the tinnitus pitch.​

Conclusion
The study-results confirm a relationship between tinnitus pitch and maximum hearing loss but not to the edge frequency, suggesting that tinnitus is rather a fill-in-phenomenon resulting from homeostatic mechanisms, than the result of deficient lateral inhibition. Sub-group analyses suggest that audiometric steepness and the side of affected ear affect this relationship. Future studies should control for these potential confounding factors.​

Reference:

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0034878​

 

Otoharmonics received FDA clearance in the beginning of September and they've begun training medical professionals. The device only seeks to facilitate habituation, like all sound therapies to date. (tinAway is the exception as they claim to be able to cure tinnitus; but we shall see. I don't believe any sound therapy will cure tinnitus.)

The invention is backed by Cedars-Sinai Hospital (a large, prestigious US non-profit hospital), and Otoharmonics current CEO is Michael Baker of the Baker Group, LLP. The Baker Group describes themselves as "A Technology Advancement Company." You can read more about the Baker Group by clicking here.

Personally, I don't believe this device will be different from the current offerings of sound therapies. But I am intrigued by the sleeping application of sound therapy. I only hope it's not some gimmick. That said, maybe the interest of big money behind the invention portends something better than your average sound therapy. Of course, like Neuromonics and SoundCure, the therapy will probably not be covered by insurance--unless you're a veteran.

Here are some excerpts from a MobihHealthNews.com about Otoharmonics, including a non-technical description of how it works:

Otoharmonics, a startup out of the Baker Group supported by Cedars-Sinai Medical Center, has received FDA 510(k) clearance for an iPad or iPod Touch application that treats a medical condition called tinnitus. Technology behind the Levo system, originally developed at Cedars-Sinai, uses sound therapy to train the brain to ignore the ringing sounds caused by tinnitus.

...​

The FDA clearance is for the whole system: the software, the earbuds, and the Apple devices themselves. This means Otoharmonics will need to get additional clearances if they want to develop future versions for Android or other platforms, or even for subsequent generations of Apple products.

With the Levo system, a doctor prescribes the system to a patient and takes molds of their ears to make custom earbuds. Then, on a follow-up visit, the doctor gives the patient the earbuds and a device with the system pre-installed. The patient uses the app to “map” the sound they’re hearing, and the app generates a therapy based on that sound. Patients listen to the app at night in order to take advantage of unconscious brain processes.

“Like ‘defragging’ a computer’s hard drive, the brain efficiently reorganizes itself while we sleep,” Otoharmonics writes on its website. “Selectively removing the unnecessary bits of information, our brain prioritizes new and stored information to lock in learning and memory. As a result, new neural connections are created, rerouted or reduced to make way for new learning and problem solving activities. By using the Levo System at night, patients leverage the brain’s natural ability to diminish the effects of tinnitus over time.”

Otoharmonics received the clearance just 90 days after submitting, according to Edin. The rollout will take some time, she said, because Otoharmonics needs to train audiologists on the system. They’re currently training professionals in Los Angeles; Portland, Oregon; New York, and Chicago.

“Unlike traditional audiology equipment, with the software on the iPod we see the patient and the provider sitting side by side and using the app together,” Edin said. “That’s kind of a new thing in that industry. Normally you see an audiologist at a desktop and they’ll turn and ask a question, go back to the desktop. You see a lot of backs of audiologists, and with hard of hearing people you need to have that face-to-face contact.”

The company will sell the system to hospitals, who will then sell to patients. Edin said that right now, because the system is considered a therapy rather than a treatment, it will be difficult for most patients to get reimbursement from payers. The exception is veterans, one of the largest groups of tinnitus sufferers, who can often get reimbursement from the VA.
​

Reference:

http://mobihealthnews.com/36288/cedars-sinai-developed-tinnitus-app-gets-fda-clearance/
​

 

I'm surprised this even needed FDA clearance. I mean, it's just an ipod with an app.

Isn't that at odds with both the study it's supposed to be based on and the supposed mechanism of action?

The study abstract says "All patients decreased their tinnitus intensity in the first month of treatment (statistically significant), most of them in the first week.". 'Decreased tinnitus intensity' sounds like a lowered volume effect, not a habituation (i.e. same volume, but less attention to it) effect, to me.

Also, the mechanism of action, as I understood it, was the reinhibition of central neurons at the affected frequencies
via sound input was supposed to reduce tinnitus. Again, this is an excitation reducing (i.e. volume reducing) effect, not habituation.

 

The LEVO system from Otoharmonics is apparently up and running.
I wonder if it works:
1) on chronic patients?
2) for those with multiple or moving tones?
@jazz
http://otoharmonics.com/public/

 

Interesting

 

http://www.prnewswire.com/news-rele...or-people-living-with-tinnitus-300150022.html

 

Well...that's just a press release, not an actually helpful review. From the sort of vague descriptions of the product I'm extremely skeptical. The fact that you have to buy into their program (which apparently involves buying an iPad and iPod Touch?) seems even more fishy. If it's just an app, then let me purchase it for a nominal fee on my existing Apple device. It would be great if this were an actual, effective treatment. If anyone tries it please let us know if you get results, but for now I'll remain skeptical.

 

Yoy can trick the brain into hearing a frequency that you cannot hear, utilizing the sum& difference.
This where the brain will create the fundamental ( freq you cannot hear) if you listen to the sum and difference of what yoy cannot hear.
In theory at least

 

this may suggest that neurofeedback may really help us? haha! by training the brain to get a certain wave in our brain?

anyway, found this elsewhere in TT. going to repost it here.
http://www.sciencedirect.com/science/article/pii/S1984006314000492

 

Could be a subsidiary of Apple computers?

 

Hi, I'm new to the forum. Was wondering if anyone has actually tried the Otoharmonics Levo system?

I've had T for over 3 months now from noise induced hearing loss at a concert. My audiologist recommended the levo system. It is really expensive and I don't want to spend the money if it's not effective.

Thanks for any info you can provide. Hope you all are doing well.

 

Well, I can't find a single person who has used this. And no response here either. The system I was offered was priced at $5,000. Perhaps that's why no one is using it. I did find an app that can help to match tinnitus frequency and could essentially be used for the same purpose, and it's only $1.99, they even have a free version. If the Levo system does work it's very unfortunate they have it priced so high. Not many people can afford five grand out of pocket for an iphone app that may or may not help.

Here's the tinnitus matching app: https://itunes.apple.com/us/app/whist-tinnitus-relief/id898838716?mt=8

 

Thanks for posting that link. For $2 I figured I'd try it out. This one matches the tone instead of notching an octave around it. I guess if someone has tonal T but can't hear at that frequency, notching is a better option. I'm currently listening and will post a follow-up either before going to bed or in the morning. The app doesn't really do anything other than match your T's frequency and volume, although the balance option is nice for the times when it's louder in one ear than the other I suppose. There's a "noise" slider where you can adjust the "noise" level so the tone you hear is less like a solid beeeeeeeeep and more like a beep mixed with static or something.

However, despite not being overly impressed by the features, my initial impressions are that this is BETTER than ACRN. Both get rid of my high-pitched tone, but the ACRN method leaves me with a hiss. In the short time I've been using this app, it has not left me with a hiss OR a tone. The sudden silence is a little startling. I hope it continues doing this.

Interestingly, when I first start listening I can hear the tone from the app clearly. Then as the minutes pass by that becomes less true. The sound seems to fade. When I noticed that happening I took out my earbuds to make sure I wasn't losing my hearing. I wasn't, but the silence when taking out the earbuds was a complete surprise.

 

So I've been listening to this app during several T spikes today and it does help get rid of both my high frequency T and hiss, but the effects don't last as long as notched white noise. I'm curious as to why it gets rid of both sounds.

There's a free version available which doesn't allow saving of your settings but does allow you to try the app to see if it works for you. There are probably other apps that do the same thing. https://itunes.apple.com/us/app/whist-tinnitus-relief-free/id937351306?mt=8

 

I live in Texas where the Levo system is not available yet, but had a nice chat with an audiologist who is both a provider and user. She resides in another state and I don't want to give her name for privacy reasons but she contends that she has had great results with it. The provider checks the initial results after thirty days on the Ipad by the data that shows if you are continually turning the sound that matches your tinnitus down on a regular basis. They claim results in ninety days. The company is seeking to provide it in this state and when they do I may do a test run.

 

It looks to me like they are selling a $1000 iPad with custom software and charging $5000 for it.

I'd buy one, if it worked. I'd love to see some actual research or data, though.

This seems like something that could be made available as a $50 mobile application.