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

Neuromonics

Status and phase: Unknown; Phase 4

Conditions: Hyperacusis; Tinnitus

Treatments: Device: Oasis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730834

20071022

CALM Study

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)