ACEMg for Hearing Loss and Tinnitus

(OTISRWD Trial)

Not currently recruiting at 1 trial location

Overseen By Richard A Detweiler, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keep Hearing, Inc.

Disqualifiers: No tinnitus, No hearing loss, Previous ACEMg use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called ACEMg, which might help with hearing loss and symptoms like ringing in the ears (tinnitus) and sensitivity to sound. The goal is to determine if ACEMg can stabilize or improve hearing and reduce these bothersome symptoms. Participants will take the supplement daily, with progress tracked using an app and online surveys. It suits adults who notice hearing loss or tinnitus. Conducted entirely at home, the study offers convenience for participants. As an unphased trial, it provides a unique opportunity to contribute to early research and potentially benefit from a novel approach to managing hearing issues.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the study coordinators or your doctor for guidance.

What prior data suggests that ACEMg is safe for treating hearing loss and tinnitus?

Research has shown that ACEMg, also known as Soundbites, is generally safe for use. As a dietary supplement, it is regulated by the FDA, ensuring it meets safety standards. In a previous study, ACEMg maintained or even improved hearing in about 75.3% of participants who took it daily. Importantly, no major safety issues have been reported.

In lab studies, ACEMg protected inner ear cells, reducing damage from loud noise. This suggests it might also help with hearing problems like tinnitus (ringing in the ears) and hyperacusis (sensitivity to sound). While these findings are promising, more research is needed to fully understand the supplement's long-term effects. Overall, current evidence supports that ACEMg is well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hearing loss and tinnitus, which often involve hearing aids or sound therapy, ACEMg offers a novel approach by combining antioxidants and magnesium in a softgel capsule. Researchers are excited about ACEMg because it targets oxidative stress and inflammation, which are thought to contribute to auditory damage. This oral supplement could provide an easier and potentially more comprehensive solution by addressing the underlying cellular issues, rather than just managing symptoms.

What evidence suggests that ACEMg might be an effective treatment for hearing loss and tinnitus?

Research has shown that ACEMg, a supplement, may help maintain or improve hearing. In a previous two-year study, 75.3% of participants who took ACEMg daily either improved their hearing or maintained stability. This finding suggests that ACEMg might assist with sensorineural hearing loss, the most common type. In this trial, participants will take ACEMg softgel capsules daily to assess its effects on hearing and tinnitus. While the earlier study primarily focused on hearing, researchers are also examining the supplement's potential to ease tinnitus (ringing in the ears) and other issues like hyperacusis, which is increased sensitivity to sound. The supplement may protect inner ear cells from damage. ^{3 6 7 8 9}

Who Is on the Research Team?

Barry Seifer, MFA

Principal Investigator

Keep Hearing, Inc. 501c3

Are You a Good Fit for This Trial?

This trial is for adults with sensorineural hearing loss (SNHL) or tinnitus. Participants will take ACEMg softgel capsules daily and must be able to complete baseline assessments, as well as follow-up evaluations at approximately 12 and 24 weeks.

Inclusion Criteria

I have reported experiencing ringing in my ears.

Hearing loss assessed at the baseline test

Exclusion Criteria

I have used ACEMg (Soundbites) before.

No hearing loss assessed at the baseline test

I do not have tinnitus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a baseline hearing assessment and, if applicable, a tinnitus survey

1 week

1 visit (virtual)

Treatment

Participants take ACEMg softgel capsules daily and repeat hearing assessments and tinnitus surveys at 12 and 24 weeks

24 weeks

2 visits (virtual)

Follow-up

Participants' data is analyzed and shared with them after the 24-week study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACEMg

Trial Overview The study tests whether ACEMg (Soundbites) can preserve or improve hearing in individuals with SNHL and if it can reduce tinnitus symptoms. It's a secondary analysis of real-world data from a previous two-year study, now focusing on results within six months.

How Is the Trial Designed?

Group I: At-home Experimental Treatment 1 Intervention

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

ACEMg is already approved in United States for the following indications:

Approved in United States as Soundbites for:

• Sensorineural hearing loss (SNHL)
• Tinnitus relief

Who Is Running the Clinical Trial?

Keep Hearing, Inc.

Lead Sponsor

Trials

1

Recruited

200+

Published Research Related to This Trial

In a study involving 472 patients, tinnitus maskers were found to be more effective than hearing aids for managing tinnitus, although hearing aids are often the first choice for patients with significant hearing loss.

The study highlighted that thorough investigation and counseling significantly benefit patients, and there is no evidence that tinnitus masking negatively affects hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of tinnitus maskers. Hazell, JW., Wood, SM., Cooper, HR., et al.[2019]

In a study of 470 patients using the Neuromonics Tinnitus Treatment, 92% of the most suitable patients (tier 1) experienced a significant reduction in tinnitus disturbance, with an average improvement of 72%.

The effectiveness of the treatment varied by patient suitability, with lower success rates and higher discontinuance rates in less suitable categories, indicating that patient selection is crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice. Hanley, PJ., Davis, PB., Paki, B., et al.[2022]

In a study involving 10 patients with tinnitus and cochlear lesions, three reported a subjective reduction in tinnitus after taking amino-oxyacetic acid, suggesting some potential efficacy of the drug for this condition.

Additionally, improvements in speech discrimination scores were observed in three patients during treatment with amino-oxyacetic acid, indicating possible benefits beyond just tinnitus relief, although the overall response was limited and varied among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amino-oxyacetic acid as a palliative in tinnitus. Reed, HT., Meltzer, J., Crews, P., et al.[2019]

The Global Trigger Tool (GTT) has been modified since its introduction in 2003 and is used to identify and characterize adverse events (AEs) in healthcare settings, with studies showing AE rates ranging from 7% to 40% in inpatient settings.

Methodological differences among studies, including the number of reviewers and inclusion of 'acts of omission,' significantly affect reported AE rates, suggesting that comparisons between institutions or studies should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of the Global Trigger Tool: a systematic review. Hibbert, PD., Molloy, CJ., Hooper, TD., et al.[2022]

Currently, there are no FDA-approved drugs specifically for treating tinnitus, leading to the availability of many unproven over-the-counter remedies that may cause harm without providing real benefits.

Animal models have been essential in understanding tinnitus and testing potential treatments, highlighting the need for more research to identify effective pharmacological therapies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Drugs in Animal Models of Tinnitus. Zheng, Y., McTavish, J., Smith, PF.[2021]

In a Phase 2b study involving 410 patients with episodic migraine, galcanezumab was generally well-tolerated, with most treatment-emergent adverse events being mild to moderate, although some serious events were reported.

Injection-site reactions were more common with galcanezumab (13.9%) compared to placebo (5.8%), and the study supports further investigation in larger Phase 3 trials due to its safety profile and potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study. Oakes, TMM., Skljarevski, V., Zhang, Q., et al.[2022]

A systematic analysis of drug bioactivities and adverse events (AEs) revealed that examining multiple protein targets can improve the detection of drugs associated with AEs, highlighting the complexity of predicting ADRs.

Out of 45 protein targets linked to AEs, 30 are already part of safety panels, while 15 new targets, including specific carbonic anhydrases, were identified, suggesting that expanding safety profiling could enhance drug safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Analysis of Protein Targets Associated with Adverse Events of Drugs from Clinical Trials and Postmarketing Reports. Smit, IA., Afzal, AM., Allen, CHG., et al.[2021]

AM-101, an NMDA receptor antagonist delivered via intratympanic injection, has shown significant and dose-dependent improvement in acute tinnitus caused by glutamate excitotoxicity, based on results from a phase II clinical trial involving patients with tinnitus from acoustic trauma or otitis media.

The optimal treatment regimen for AM-101 was found to be three injections over three consecutive days, which provided the best outcomes for tinnitus improvement compared to a single dose or a three-dose regimen over two weeks, indicating that repeated inhibition of NMDA receptors is effective while minimizing patient burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus. Staecker, H., Maxwell, KS., Morris, JR., et al.[2015]

Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.

In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. Essex, MN., Zhang, RY., Berger, MF., et al.[2022]

In a review of 231 randomized placebo-controlled clinical trials, it was found that a staggering 96.8% of adverse events (AEs) reported in patients taking active drugs were nonspecific, meaning they were not directly related to the medication.

The study revealed strong correlations between AE rates in placebo and active-drug groups, indicating that many reported AEs may not be caused by the drug itself, which raises concerns about the reliability of clinical trial data in assessing drug tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Mahr, A., Golmard, C., Pham, E., et al.[2022]

Approximately 10% of adults experience clinically significant tinnitus, with 1% suffering severe impacts on their quality of life, highlighting a critical need for effective treatments.

Recent advancements in understanding tinnitus mechanisms, animal models, and clinical trial methods have led to increased pharmaceutical interest, with several new compounds targeting tinnitus currently in development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacotherapy of tinnitus. Langguth, B., Elgoyhen, AB.[2011]

In a study involving 248 patients with persistent tinnitus, intratympanic AM-101 (0.81 mg/ml) showed significant improvements in tinnitus loudness, annoyance, sleep difficulties, and overall impact, particularly in those with tinnitus from noise trauma or acute otitis media.

Although the primary endpoint of minimum masking level did not show a treatment benefit, the study suggests that patient-reported outcomes may be more effective measures for evaluating tinnitus treatments than traditional psychoacoustic tests, and AM-101 was well tolerated with no significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus--a double-blind, randomized, placebo-controlled phase II study. van de Heyning, P., Muehlmeier, G., Cox, T., et al.[2022]

A 3-day continuing education workshop on tinnitus management significantly improved audiologists' knowledge and confidence, with participants rating the workshop's usefulness very high both immediately after (mean 4.8) and three months later (mean 4.2).

Participants reported implementing changes in their practice based on the workshop content, indicating that the training effectively translated into practical application, although ongoing support was identified as necessary for continued improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of a Continuing Education Workshop for Audiologists on the Assessment and Management of Tinnitus. Searchfield, GD., Fok, C., Donaldson, T., et al.[2021]

In a study of 133 tinnitus patients, those whose tinnitus frequencies were related to Distortion Product Otoacoustic Emissions (DPOAEs) showed a significantly higher treatment efficacy rate of 75.3% compared to 36.7% in those without this relationship after 14 days of drug therapy.

The results suggest that personalized drug therapy, including injections of Lipo PGE1 and vitamins B1 and B12, can be particularly effective for patients with acute tinnitus linked to specific auditory characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study on relationship between distortion product otoacoustic emissions and therapeutic effects in tinnitus]. Zhang, J., Zhou, H., Xu, Y., et al.[2009]

Citations

1. soundbites.com soundbites.com/?srsltid=AfmBOopPfPaYQvJqY11NN5wGKWlvbl2pqxiU-WZ83mh8gHaqajUr3vgW

Soundbites PBC: Preventive Healthcare for Hearing ... A landmark 2005 lab study demonstrated the ACEMg formula protected inner ear cells from oxidative stress-related noise damage up to 30dB, reducing noise- ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06477354/acemg-hearing-preservation-tinnitus-and-hyperacusis-relief

ACEMg Hearing Preservation, Tinnitus and Hyperacusis ... Soundbites was clinically proven to preserve or improve hearing for 75.3% of those who took it daily. Among those who benefited, hearing loss ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11077254/

Investigation of the effectiveness of sound enrichment in the ... Sound enrichment treatment can be effective in tinnitus cases where RI is positive and the tinnitus pitch is matched with a hearing loss between 45 and 55 dB ...

4. soundbites.com soundbites.com/pages/tinnitus-and-hyperacusis?srsltid=AfmBOoogPqADVi76kRtHlomNiH71eIrdAfSmxOhuSq_ThiSNG1TAs-UC

Tinnitus & Hyperacusis Guide | Hidden Hearing Loss Outer hair cell hearing loss (HL)​​ A 2-year clinical study demonstrated that ACEMg preserved or improved OHC function for 75.3% of study participants who took ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1808869422000404

Hearing aid effectiveness on patients with chronic tinnitus ... Our study has provided evidence that HA fitting is a valuable treatment strategy for chronic tinnitus relief and associated hearing loss subtype of patient.

6. soundbites.com soundbites.com/pages/safety-and-ingredients?srsltid=AfmBOopnSLAg1xAj9lG6z1VMAyHzJevgj9gXrqMCW6mfYBRtqEaVyIMz

safety and ingredients ACEMg (Soundbites) is a safe, multi-patented inner ear neuroprotectant formulated as a dietary supplement and regulated as such by the FDA. It is available ...

7. soundbites.com soundbites.com/?srsltid=AfmBOorOhIcIg5n5GF-NjaaLseQsO26zUnjUsNHcxQTtha9715ONgeTx

Soundbites PBC: Preventive Healthcare for Hearing ... A landmark 2005 lab study demonstrated the ACEMg formula protected inner ear cells from oxidative stress-related noise damage up to 30dB, reducing noise-induced ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) The current supplement to add an indication for single sided deafness or unilateral hearing loss (SSD/UHL) in children and adults. II.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01445977

SoundBite Hearing System Long Term Multi Site Patient ... The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI ...