Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

Neuromonics, Inc.53 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tinnitus Hyperacusis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pre and post treatment scores on Tinnitus reaction questionnaire

Time frame: 6, 12, 24, 36 months

Secondary Outcomes

Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,