1 Tinnitus Alleviation Via Sensory Substitution
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      This is a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound
      that arrives at the ears naturally will be presented in the form of touch patterns on the
      tongue. By learning to associate the sounds in the ears with the sound patterns on the
      tongue, investigators aim to demonstrate that the brain will learn to discriminate the real
      sounds from legitimate external sounds from the imaginary tinnitus sounds that are created
      inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing
      in the ears' that affects an estimated 40 million people globally (American Tinnitus
      Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception
      of illusory sound that has no legitimate external source and normally arises from a small
      number of underlying neuropathologies. There are broadly two categories of tinnitus Somatic
      Tinnitus and Hearing Loss Related Tinnitus.

      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The
      study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The
      objective of the study will be to determine the impact of acoustic and tactile multi-modal
      neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and
      subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking
      (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale
      (VAS).
    

Detailed description: 
      This study will be a prospective single arm pilot study. It will be conducted with approval
      from the Research Ethics Committee of NUI Maynooth and The Hermitage Medical Clinic Lucan in
      collaboration with Mutebutton Ltd, Nova UCD. This study will be conducted over a 16-week
      period with 60 suffering from permanent intractable tinnitus (>6 months) and with an
      accompanying/ co-existing high-frequency hearing-loss. Participants will be screened for a
      4-week run-in period prior to commencement of treatment where baseline measures will be
      obtained and sampled every 2 weeks. Following this run-in period they will receive treatment
      for 10 weeks and will be followed up 2 weeks post-treatment. For the duration of the study
      they will be assessed every 2 weeks in the clinical environment. Participants will be given
      the IFU (Appendix 3) along with the device and given step by step instructions on how to use
      it, and a detailed description of each control, indicator and connection. Participants will
      use the MuteButton device for minimum of 1 hour a day for a period of 10 weeks.

      The efficacy of the intervention will be assessed by the change in several psychoascoutic
      assessments assessed every at each of the 6 follow up visits with the investigators at 2 week
      intervals.

      The Psychoacoustic Assessment will include:

      Tinnitus Matching (Pitch) - symptom severity Tinnitus Loudness Matching (TLM ) - symptom
      severity Minimum Masking Level (MML) - symptom severity

      Questionnaires to be utilised will include:

      Visual Analogue Scale (VAS) - symptom severity Tinnitus Handicap Inventory (THI) - symptom
      severity A primary endpoint at 16 weeks is to show a reduction in a THI, and psychoacoustic
      assessment will be established. Secondary endpoint will include reduction in MML, and
      psychoacoustic assessment will be established.
    

Intervention name(s): Mutebutton intervention
Intervention type(s): Device
Intervention description(s): Participants are asked to use the MuteButton daily for 30-40 minutes.They receive 'pink noise' through headphones and transcutaneous stimulation on the tongue using a 'lollypop' sensor that sits on the anterior section (tip) of the tongue.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be persons who are diagnosed as having tinitus by an audiologists
        that are at least 18 years of age. It is expected that the user age distribution will be
        skewed towards an older deomographic due to the increased prevalence of hearing
        loss-related tinnitus in the elderly.