Mahana Tinnitus Pilot

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MHNA-003	MHNA-003	MHNA-003 is a self-guided digital program for people living with tinnitus

Primary Outcome Measures

Name	Time	Method
Mean Change in TFI Score From Baseline to Week 6	6 weeks	The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. An improvement of 13 or more points is considered a clinically meaningful change.
Tinnitus Functional Index Responder Rate	6 weeks	The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. A responder is defined as a participant who experienced an improvement of 13 or more points from baseline to Week 6. The responder rate is the percentage of participants considered responders at Week 6.

Secondary Outcome Measures