Hyperacusis, Tinnitus
Conditions
Keywords
tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant, discomfort
Brief summary
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).
Interventions
DEVICEOasis
Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
Sponsors
Neuromonics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age, * TRQ of at least 17 or above, * Able to pay for the treatment, * Not using any other treatment for tinnitus, * Access to computer and internet, * Compliant patient
Exclusion criteria
* Hearing PTA \> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale, * Not willing to follow the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre and post treatment scores on Tinnitus reaction questionnaire | 6, 12, 24, 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, | 6, 12, 24, 36 months |
Countries
United States
Outcome results
None listed