Mahana Tinnitus Pilot

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.

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.