New hope has been offered to the UK’s 6 million tinnitus sufferers following a trial conducted by the National Center for Rehabilitative Auditory Research (NCRAR) in the United States.
The independent trial demonstrated that individuals treated with Levo® Sound Therapy experienced a reduction in perceived tinnitus loudness of more than 20 per cent, as well as a drop in tinnitus distress of more than a third, compared with those treated with the standard care therapy and a placebo.
Over a 12-week period, participants with primary tinnitus demonstrated:
- A reduction of 21.9% in reported tinnitus loudness perception compared to a reduction of 4.5% in those using the standard of care
- A reduction of 37.6% in tinnitus distress compared to a reduction of 23.5% in those using the standard of care
The patients were asked to grade the loudness of their tinnitus using a sensitive numerical rating scale. The distress impact of the tinnitus was also assessed using a questionnaire which evaluates the emotional impact of the condition.
Tinnitus affects around 10% of the adult population in the UK and in its severe form can cause sleep loss, anxiety, depression and a significant reduction in quality of life.
The Levo® System for tinnitus therapy uses iPod technology to deliver a personalised tinnitus sound straight to the brain while the patient sleeps. The brain learns to ignore the hissing or buzzing associated with this debilitating and often stressful condition and over time, the patient notices the tinnitus less during the day.
The sound-based therapy, which sees an iPod being approved for use as a medical device for the first time, has already been providing relief for tinnitus sufferers in the US since 2014.
Now, the FDA cleared and CE approved product is available exclusively in the UK at the Tinnitus Clinic.
Mark Williams, Chief Audiologist at the Tinnitus Clinic in Harley Street, commented:
“This important piece of work demonstrates the effectiveness of the Levo® Sound System in treating bothersome tinnitus in adults.
“The study, because it is independently executed, provides a higher grade of evidence to support the use of this product in clinical practice.
“The prospect of being able to treat a patient with tinnitus while they sleep is a new and exciting proposition which will hopefully improve the patient usability of the device.”
The randomised control trial (RCT) was conducted, independently, at NCRAR at the VA Portland Health Care System (VAPORHCS). Sixty participants, with primary tinnitus,
were divided into three groups each receiving different therapy treatment for 12 weeks.
The study demonstrated Levo® targeted sound therapy to reduce perceived tinnitus loudness and distress by a statistically significant degree over a 12-week period and to be more effective than conventional nocturnal sound enrichment treatments.