Editor's Note: There is no "cure" for tinnitus. This is true of Arches and all other tinnitus products. But there are valid, science-based treatments that will be effective for some and not others. Knowing this, it has always been our policy to present to our readers other valid treatments. Neuromonics and Tinnitus
by Barry Keate
Australian audiologist Dr. Paul Davis developed Neuromonics Tinnitus Treatment in the late 1990s and has continued to improve it since then. The goal of this treatment is not to reduce tinnitus but to desensitize the brain to the sounds of tinnitus and to reduce the patient’s annoyance with the sound. In this regard it is similar to an older treatment protocol,Tinnitus Retraining Therapy (TRT).
With both TRT and Neuromonics, the aim is to reduce both the perception and the annoyance of tinnitus. Neuromonics approaches this using a specialized acoustic stimulus aimed at targeting the effects of auditory deprivation and combining this with relaxing music. The acoustic stimulus component is used to desensitize the brain to tinnitus by “reprogramming” neuronal responses. The music component is used to reduce the involvement of the limbic and autonomic nervous systems in the perception of tinnitus. The limbic system is responsible for emotions, among other functions. The autonomic system regulates the “fight or flight” response, the biological reaction of animals to acute stress. Both of these nervous system responses combine to add a level of distress to the perception of tinnitus.
Both therapies involve the use of sound generators and counseling, which are used to address the auditory, psychological and neurological elements of tinnitus. The treatment protocol for TRT consists of an in-the-ear sound generator to mask tinnitus sound. Neuromonics uses a customized acoustic stimulus that matches the auditory profile of the patient instead of the one-size-fits-all sound generator used in TRT. It embeds this sound within relaxing music. It is played on an MP3-like device and listened to with high fidelity headphones.
Neuromonics can be considered an advancement on TRT. Whereas TRT treatment requires up to two years, typical Neuromonics treatment is for six to eight months.
Until recently, the only studies available on Neuromonics were funded and conducted by the company. Now there is an independent clinical study, published in the International Tinnitus Journal and conducted at the House Ear Clinic in Los Angeles, that sheds more light on the treatment.
All patients who initiated treatment at the House Ear Clinic between August 2007 and July 2009 were included in the study. A total of 47 patients underwent the initial assessment and received the Neuromonics device. They were divided into three groups; 14 patients who had completed the 6-8 month course, 18 patients who were still in active treatment and 15 patients who had returned the device and did not complete the treatment.
Procedure An initial patient assessment was performed on the first visit and each patient completed a Tinnitus Reaction Questionnaire (TRQ). The TRQ is designed as a means of assessing the effect tinnitus has on an individual’s quality of life. TRQ scores range from 0 (no bothersome tinnitus) to 104 (maximally bothersome tinnitus). Tinnitus pitch matching, broadband masking threshold, measurement of loudness sensitivity and other tests were also conducted.
During the second visit, the patients were fitted for the Neuromonics Device. The audiologist set the minimum volume, determined the levels for use at different stages in the protocol, and discussed device usage and management. The patient was counseled to use the device for 2-4 hours per day.
During phase one of the treatment, the background stimulus noise was consistently present while the intensity of the relaxing music was periodically altered.
After two months, patients repeated audiological testing, completed a new TRQ and were transitioned into phase two of the treatment. During this phase, the stimulus noise was dropped completely and the patient listened only to the relaxing music during treatment sessions.
After four months, patients completed another TRQ and were retested for several parameters. They were told to turn the volume of the device down so they could hear their tinnitus 60% of the time and the music the other 40%. This was for the purpose of desensitizing to the tinnitus. They were also instructed to decrease use of the device to 2-4 hours per week and eventually use it only when needed. At 6 months, they completed a new TRQ and underwent a repeat of the audiological test battery.
Results The study began with three groups; those who had previously finished the treatment protocol, those who were still in treatment, and those who elected to not continue treatment.
Fifteen patients (31.9%) elected to discontinue treatment and returned the device. Most claimed the device was of no help while 4 patients reported that it made their tinnitus worse.
For the 18 patients in the active group (38.3%) who had not finished therapy, the mean reduction in TRQ score was 56%.
For the 14 patients in the completed group (29.8%), the average reduction in TRQ scores was 61.6%.
Across all 47 patients in the study, 48.9% achieved a successful reduction of 40% or more in TRQ score.
The researchers compared TRQ test scores to the duration of tinnitus in the patient. They found what appears to be a tendency for those with early onset tinnitus (a very short duration of symptoms) to show the most improvement. Across all patients, the percentage of improvement declined with the longer they had their tinnitus.
Researchers stated, “It will be important to delineate which candidates are more likely to benefit from treatment with the Neuromonics device, and initial severity of symptoms is one factor warranting further study.” Also, further studies will be needed to determine long-term efficacy of the treatment device.
The authors state in this paper that “Tinnitus is not a disease but rather a complex symptom believed to result from abnormalities in central and peripheral auditory pathways.” Also, “Unlike those with a specific disease process, patients with tinnitus need not necessarily go through a series of progressively more involved treatments.”
Author's Comments There are three shortcomings to this study that I will address here.
1 – Very small number of participants. As stated in the referenced article, “The number of patients in any one group and duration category are too small for statistical analysis.” Clinical trials need to consist of at least several hundred patients before trends can be seen clearly.
2 - No placebo group. A placebo group is a control group given what they think is a real treatment but is actually a sham treatment. This study was not a double-blind, placebo controlled trial. All participants were given the real Neuromonics device; all patients knew this as well as the researchers. The patients therefore expected to improve and many may have improved who otherwise may not have. This is known as the placebo effect. It is thought that, by not using a placebo control, results in clinical trials can be skewed by up to 40%.
3 – Lack of follow-up on long-term benefits from the device. No one knows the extent of relief after 6 months, one year or five years. It is possible the reprogramming of neuronal responses is only temporary and the patient will have to undergo continuous therapy.
My own belief is that there is a place in the tinnitus treatment protocol for Neuromonics. It is one valid therapy among many others. There is no single treatment that is helpful for all people and this is true for Neuromonics; it will help some people but not others.
As far as practical matters including time involved and cost, both are quite high for Neuromonics. Pricing ranges from about $3,500 to $6,000 (including counseling visits), and must be used for 2-4 hours per day over several months. I can envision a very high non-compliance rate; people who enthusiastically start treatment but lose enthusiasm and discipline after so much involvement and time is required.
The stated success rate of Neuromonics is 48.9% of patients achieving a 40% or more reduction in annoyance level. If the results of this non-placebo controlled study are to be believed, at best it’s success rate is no better than the approximate success rate of Arches Tinnitus Formulas. Dr. Seidman states, “Approximately half of my patients are satisfied with their results and elect to continue taking the products, requiring no further treatment from me.” Also, numerous clinical studies on the ingredients used in Arches Tinnitus Formulas, (placebo controlled, double-blind studies), conducted on thousands of tinnitus patients, show statistically significant reductions in tinnitus in the majority of patients.
The cost of the Arches Tinnitus Combo Pack is about $165.00. This is a three-month supply of all our products designed to reduce tinnitus noise. At the end of three months, the patient can determine whether to continue with the product or, if there has not been substantial relief, the patient can discontinue use.
A logical course would be to follow Dr. Seidman’s standard tinnitus protocol by starting with the simplest and least expensive treatment, Arches Tinnitus Formulas. Then, based on results from that, the individual can determine whether to continue or go to the more expensive and time-consuming treatments.
1 -Goddard JC, Berliner K, Luxford WM. Recent Experience with the Neuromonics Tinnitus Treatment. International Tinnitus Journal, Vol. 15, No. 2, 168-173 (2009).