Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06508060
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide and understand informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Initial Tinnitus Functional Index Score of 42 points or higher indicating mild, moderate, or severe tinnitus
* Subjective tinnitus that is described as tonal or white noise
* Age 22 and over at the time of consent
* Ability to read and understand English
* Tinnitus duration for greater than or equal to 3 months
* Able to provide an audiogram performed by a licensed audiologist within the past 12 months
Exclusion Criteria:
* Individuals who are non-English speaking
* Subjective tinnitus, where pulsatility is the dominant feature (participant reported)
* Objective tinnitus, where the tinnitus is also observed by the examiner
* Commenced usage of hearing aid within the last 90 days
* Meniere\'s disease
* Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
* TMJ Disorder
* Pregnancy
* Neurological condition that may lead to seizures or loss of consciousness (e.g. epilepsy)
* Severe cognitive impairment based on MMSE (score less than 20)
* Abnormal findings following otoscopy/tympanometry that may be contributing to or causing the tinnitus as assessed by an Audiologist/ENT (participant reported)
* Initiated new prescription medications or medical treatments in the previous 3 months
* Ceased prescription medications or medical treatments in the previous 3 months
* Participant previously diagnosed with psychosis or schizophrenia
* Previous use of Neosensory Duo
* Previous involvement in a clinical investigation for tinnitus or had an experimental/surgical treatment for tinnitus
* Hearing loss of greater than 80 dB HL in any test frequency in the set {2k,3k,4k,6k,8k} Hz or greater than 40 dB HL in the set {250,500,1k} Hz either unilaterally or bilaterally. This information will be obtained from an audiogram performed by a licensed audiologist, that is provided by the candidate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06508060
Study Brief:
Protocol Section:
NCT06508060