Mahana Tinnitus Pilot

Mahana Therapeutics

Status

Completed

Conditions

Tinnitus

Treatments

Device: MHNA-003

Study type

Interventional

Funder types

Industry

Identifiers

NCT05696158

MHNA-003-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.