ACEMg Hearing Preservation, Tinnitus and Hyperacusis Relief

NCT06477354 | Completed DMC

• 1 other identifier: ACEMg OTIS Study
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

ACEMg (Soundbites) is a neuroprotectant supplement designed to block the initiating biological events in the inner ear leading to inner ear hearing loss, sensorineural hearing loss, SNHL, which accounts for more than 90% of all hearing loss. SNHL is so common it is called hearing loss. There is no cure for SNHL. The 24-week OTIS Study aims to validate findings from the previous two-year real-world study demonstrating ACEMg (Soundbites) preserved or improved auditory function (hearing) for 75.3% of participants who used it daily, with most improvement occurring within six months. The study also aims to assess the potential of ACEMg to relieve tinnitus, hyperacusis, and hearing sensitivity symptoms. These symptoms are often correlated with SNHL; relief from tinnitus, hyperacusis and hearing sensitivity were were not measured in the previous two-year study. The OTIS study aims to answer two questions. First, does the real-world data demonstrate that hearing loss is stabilized or improved at the end of the test among participants with SNHL at the beginning? Second, do participants who self-report tinnitus, hyperacusis, or hearing sensitivity symptoms at the start of their test report reduced symptoms at the end? Participants must be eighteen years of age and older and self-report hearing loss and/or tinnitus. The study is conducted at home using a smartphone app and a web-based assessment and data reporting tool developed for this study. The study is conducted at home using an online hearing test and short surveys on tinnitus and hyperacusis. The tests are completed three times: Baseline tests are taken before participants begin to take ACEMg softgel capsules daily. The Test is repeated at about 11 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end. Participation in the study is free.

Conditions

Tinnitus; SNHL; Sensorineural Hearing Loss; Inner Ear Hearing Loss

Keywords

Phase IV open-label post-marketing surveillance; Hearing preservation; Tinnitus; SNHL; Hearing preventive care; ACEMg; Nutraceutical; Real-world data (RWD) analysis; Soundbites; Tinnitus symptom refief

Outcome Measures

Primary Outcomes (2)

• Subjective measure of preservation or improvement of inner ear auditory function

  Hearing assessments using the hearWHO digits-in-noise test

  Time point zero; 12 and 24 weeks.

• Tinnitus symptom relief

  Subjective assessment of tinnitus symptoms using the tinnitus survey

  Time point zero; 12 and 24 weeks.

Study Arms (1)

At-home

EXPERIMENTAL

Subjective auditory function assessments with the hearWHO app. Tinnitus survey. Participants take ACEMg softgel capsules daily, self-administered orally.

Dietary Supplement: ACEMg

Interventions

ACEMg DIETARY_SUPPLEMENT

Softgel capsules

Also known as: Soundbites

At-home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tinnitus self-reported at the baseline survey, or
• Hearing loss assessed at the baseline test

You may not qualify if:

• No tinnitus self-reported at the baseline survey, or
• No hearing loss assessed at the baseline test
• Previous use of ACEMg (Soundbites)

Sponsors & Collaborators

• Keep Hearing, Inc.: lead

Study Sites (1)

To enroll, visit the Participate in Public Health Research page on keephearing.org

Ann Arbor, Michigan, 48104, United States

Location

Related Links

• Impact of the ACEMg Biomedicine on Sensorineural Hearing Loss and Auditory Function: Analysis of Real-World Clinical Data

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Tinnitus

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Seifer, MFA

  Keep Hearing, Inc. 501c3

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, post-marketing surveillance

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 27, 2024
• Study Start: November 18, 2024
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)