BeyondTinnitus® is established on foundation of previously done or ongoing independent clinical studies and has raised from several years of research and experience. These studies and the basis of the BeyondTInnitus protocols have been funded by grants from the National Institutes of Health, The U.S. Military, as well as the American Tinnitus Association
In the first study, 20 subjects had tinnitus pitch matching performed using the web-based interface developed by Elinava Technologies and by an audiologist using an audiometer. It was found that a web-based protocol for tinnitus frequency matching was as accurate as the standard audiometric protocol but took less time. This study was presented at the American Academy of Otolaryngology - Head and Neck Surgery in San Francisco, CA in September 2011. The study was published in the journal Annals of Otology Rhinology and Laryngology in 2012. Please click here for the study information.
In the second study, 32 subjects were enrolled. The subjects matched their tinnitus frequency using a web-based protocol. A customized Harmonic Sound Therapy file was downloaded by the patient onto an MP3 player. The subjects listened to the sound file for one hour using open-ear headphones at a level equal to tinnitus loudness (mixing-point). Tinnitus loudness mean decreased from 6 (range, 0-10) to 3.3 (range, 0-6) after one hour of sound therapy. A reduction in loudness was seen in 88% of subjects, while 72% experienced a reduction of 25% or more, 34% of subjects had 50% reduction and finally 13% of subjects were completely releived from having tinnitus temporarily. Tinnitus annoyance decreased from an average of 6.1 (range, 1-10) to 3.1 (range, 0-8). Median duration of residual inhibition was 60 minutes, with an average of 86 minutes (range, 0-720). The two key conclusions of this second study applicable to this proposal are that 1) customized sound therapy can be delivered via the internet, and 2) Harmonic Sound Therapy is effective in reducing the loudness and annoyance of tinnitus in a diverse group of subjects. This study was presented at the American Academy of Otolaryngology - Head and Neck Surgery in San Francisco, CA in September 2011. The study was published in the International Tinnitus Journal. Click here for the study details.
In a third study, 28 subjects were enrolled in the full Elinava Technologies Tinnitus Rehabilitation Program, including the education, induction, and the harmonic sound and music therapy. Overall, 24 of 28 subjects (89%) had a reduction in the tinnitus loudness and annoyance. The residual inhibition after 1 minute of stimulation increased over time. No adverse events have occurred and no increase in tinnitus loudness has been found in any of the subjects. The results of this study were presented at the International State of the Science Meeting on Blast Induced Tinnitus in Chantilly, VA in November 2011. Click here for more information from the meeting.
In a fourth study, the Elinava Technologies Tinnitus Rehabilitation Program was compared to white noise therapy – the standard of treatment by audiologists. The study’s main aim was to see if there was any additional benefit of using a customized sound therapy over white noise therapy. A group of 18 subjects were randomized into two treatment groups. One group initially received white noise therapy for 2 hours a day for 3 months. The other group received the Elinava Technologies Tinnitus Rehabilitation Program. After 3 months of treatment, we re-measured the patients’ tinnitus loudness, annoyance, and minimum masking level (how much sound is needed to cover up the tinnitus – a measure of the tinnitus loudness). Then the two groups were given 1 month without sound therapy, also called a “washout” period to take away the effect of the treatment. Then, the two groups were switched – so the group that used the white noise therapy received customized sound therapy for this portion of the study and vice versa. The treatment was continued for another 3 months and the tinnitus was re-measured. The study found that with customized sound therapy, mean loudness decreased by 23%, mean Tinnitus Handicap Inventory score decreased 25%, mean anxiety decreased 22%, and MML decreased from 23%. After 3 months of broadband white noise therapy there was no significant change in the parameters measured (loudness, annoyance, Tinnitus Handicap Inventory, etc. This study was published in 2017 in the Annals of Otology Rhinology and Laryngology. Click here for more information on this study.
In a fifth study, the Elinava Technologies Tinnitus Rehabilitation Program was combined with an online cognitive behavioral therapy developed by Elinava Technologies. The group of 20 patients were treated with the combination of tinnitus customized sound therapy and cognitive behavioral therapy all delivered through an app on a mobile device. A group of 10 patients were used as control to see if just waiting 2 months would on its own improve tinnitus. After 8 weeks of therapy, the treatment group had a significantly greater improvement in Tinnitus Handicap Inventory score compared to control. The improvement in the treatment group was 3.3 times more than the control group. Click Click here for more information on this study.