Mahana Tinnitus Pilot

A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus

The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.

Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.

Inclusion Criteria:

• Participant scores ≥ 25 on the Tinnitus Functional Index.
• Participant has experienced symptoms of tinnitus for at least 3 months.
• Participant is at least 18 years of age at the time of consent.
• Participant resides in the United States.
• Participant is able to speak, read, and understand English.
• Participant has access to an iOS or Android smartphone with the ability to complete study tasks.
• Participant is able to commit the time required to complete therapy modules and study assessments.

Exclusion Criteria:

• Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI).
• Participant has been hospitalized for psychiatric reasons within 12 months of screening.
• Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.