Clinical Experience

Paired VNS™ treatment uses Vagus Nerve Stimulation (VNS) paired with tones

Rigorous Design
  • - Multicenter (4 site), U.S. study with 100% data monitoring through blinded phase; ongoing monitoring
  • -FDA reviewed, IDE (investigational) study of 30 patients
  • - Double blind, randomized, controlled study (one of the few tinnitus studies to use this design)
  • - All subjects implanted but Control subjects received unpaired, ineffective VNS and tones for 6 weeks while VNS subjects received Paired VNS™; all subjects received effective VNS after 6 weeks.
  • - Patients in both groups had tried an average of four previous tinnitus treatments
Rigorous Execution
  • - Blinded results at 6-weeks, continuing long-term data at 3-months, 6-months, 9-months, and 12-months
  • - 96% compliance with daily at-home therapy using the Serenity® System
  • - Study used most-common tinnitus study endpoint (Tinnitus Handicap Inventory - THI) Source: Tinnitus Research Initiative meeting, Regensburg, July 2006. Prog Brain Res. 2007;166:525-36; Laryngoscope. 2011 Jul;121(7):1555-64.
  • - VNS was statistically different (improved) compared to baseline while Control was not improved

Clinical Results from our Tinnitus Study, a randomized, sham-controlled, multi-center 30 patient U.S. trial demonstrate that vagus nerve stimulation paired with tones (Paired VNS™) using the Serenity® System is a promising new method of treating chronic tinnitus.

Efficacy:
Overall, 56% of patients experienced a clinically significant improvement, which is defined as a 20% or greater change in their Tinnitus Handicap Index (THI) score. (Fig. 1)

The Paired VNS™ treatment group showed a 31% reduction after 12 weeks in their THI score compared to a 5% reduction in the control group receiving sham stimulation (non-paired VNS). (Fig 2)

Additionally, each of our responders in the study had a reduction in their severity level by at least one category as defined by the THI (i.e. from severe to moderate or from moderate to slight).

THI Responder Rate
THI Change Chart

The average patient in the study had tinnitus for 18 years and had tried 4 other treatments

96% patient compliance with daily therapy

The subjects in the U.S. tinnitus trial used the Serenity® System at home. During the first 12 weeks, the patients did the therapy for 2.5 hours daily. The daily sessions could be divided into two time periods if desired. Based on the initial therapy outcomes, an audiologist or doctor may adjust the therapy settings and treatment duration. The goal of adjusting the therapy settings is to provide the greatest effectiveness for the therapy.

Tinnitus Clinical Study Design

Tinnitus Study Design
Key Inclusion Criteria
  • - 22 to 65 years of age
  • - Diagnosed with sensorineural tinnitus with at least some tonal quality
  • - Unilateral or bilateral tinnitus
  • - Tinnitus for at least one year and failed at least one tinnitus therapy
  • - MML >= 7 dB
  • - 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
  • - Willing and able to understand and comply with all study-related procedures during the course of the study
Key Exclusion Criteria
  • - Severe hearing loss in any ear
  • - Meniere’s disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
  • - Pregnant or plan on becoming pregnant
  • - Likely to require MRI during the study duration
  • - Any drug thought to impact the effects of the vagus (any other neuromodulator)
  • - Significant cardiac history

Demographics and Characteristics

Baseline Characteristic Active VNS Control
Mean (SD) (n=16) (n=14)
Age (years) 55.9 (7.6) 54.9(9.1)
Tinnitus duration (years) 18.8 (17.1) 10.1(10.3)
Tinnitus Handicap Inventory (THI) 52.5(22.6) 53.6(18.5)

Safety

The Serenity® System was well tolerated with similar safety and adverse events as VNS treatment for epilepsy, which has now been implanted in over 100,000 patients worldwide over the past 21 years.

In general, adverse events were mild and resolved. Two out of 30 subjects did experience some vocal cord paralysis (hoarseness or voice weakness) after implant that lasted longer than 12 weeks, although there has been ongoing improvement over time. This was an expected event, similar to the rate seen in Cyberonics first two epilepsy studies (where 1 of 16 subjects had vocal cord paralysis). The added auditory stimuli (tones) with VNS did not affect speech or hearing. This study showed that therapy pairing VNS with tones had a similar side effect and safety profile as VNS therapy for epilepsy and depression.

Click HERE to see a list of publications from MicroTransponder on tinnitus.

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