Personal Amplifier for Hearing Loss

(HearVA-ED Trial)

Recruiting at6 trial locations

Overseen by Joshua Chodosh, MD MSHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: High acuity, Cochlear implants, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if giving personal amplifiers to Veterans with hearing difficulties in emergency departments can help them hear better and understand medical instructions. The study aims to see if this can reduce their need to return to the emergency department shortly after their visit. If successful, this simple solution could be used widely in VA emergency departments across the country.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Personal Amplifier for Hearing Loss safe for humans?

The research on personal amplifiers for hearing loss does not specifically address safety concerns, but it does highlight variability in user experiences and preferences. No specific safety issues were reported in the studies reviewed. ^{1 2 3 4 5}

How is the Personal Amplifier treatment different from other treatments for hearing loss?

The Personal Amplifier is unique because it is not classified as a hearing aid by the FDA, meaning it is not subject to the same regulations. It offers sharply peaked frequency responses and is evaluated for its electroacoustic properties, providing a flexible option for those with sensorineural hearing loss who may prefer power and low-frequency amplification. ^{2 6 7 8 9}

Research Team

Joshua Chodosh, MD MSHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

This trial is for Veterans with hearing difficulties who can consent to research, speak English or Spanish, and have a medium to low emergency severity index. It's not for those with high acuity emergencies, cochlear implants, or minimal hearing issues as per the Hearing Handicap Inventory-Screen.

Inclusion Criteria

English speaking

I am able to understand and agree to participate in this study.

Emergency severity index criterion of 3 (medium), 4, or 5 (low acuity)

Exclusion Criteria

Inability to speak English

I am unable to give consent for research participation.

Emergency severity index criterion of 1-2 (high acuity)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Efficacy Study

Establish feasibility and acceptability of research and procedures in the ED environment

Completed

Definitive Efficacy and Implementation Study

Conduct a larger efficacy study and detailed implementation study across six VA Emergency Department Sites

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

Follow-up phone call 3-5 days and 30-35 days after ED discharge

Treatment Details

Interventions

• No Personal Amplifier (Behavioural Intervention)
• Personal Amplifier (Behavioural Intervention)

Trial Overview The study tests if personal amplifiers help Veteran patients in emergency departments hear better and understand discharge instructions more clearly, potentially reducing quick return visits. The program's feasibility when run by ED staff will also be assessed.

Participant Groups

Group I: Intervention: Personal Amplifier Experimental Treatment 1 Intervention

Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department

Group II: Control: No Personal Amplifier Experimental Treatment 1 Intervention

Consenting participants will be randomly assigned to the control group while receiving care in the emergency department

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

New York University Grossman School of Medicine

Collaborator

Trials

2

Recruited

1,300+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Findings from Research

In a study involving 25 older adults with mild-to-moderate hearing loss, audiologist-fitted hearing aids provided significantly better speech recognition and reduced listening effort compared to self-adjusted personal sound amplification products (PSAPs).

While hearing aids offered superior audibility and performance, all PSAPs still improved speech recognition and listening effort compared to no amplification, making them a potential budget-friendly alternative for those unable to afford traditional hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Brody, L., Wu, YH., Stangl, E.[2022]

Personal amplifiers, which are not regulated as hearing aids by the FDA, were evaluated for their effectiveness and issues in adults with sensorineural hearing loss.

The study found that while the amplifiers had sharply peaked frequency responses, user preferences varied widely, indicating that some individuals may benefit from specific amplification settings, particularly for low frequencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Hardwire Personal Assistive Listening Devices. Dempsey, JJ., Ross, M.[2015]

A review of adverse event reports indicated that hearing loss associated with otic medications primarily affects older dogs, particularly those over 10 years old, with no specific products linked to increased risk.

Hearing loss may result from various factors beyond ototoxicity, including the underlying ear conditions, age-related hearing decline, or other anatomical issues, highlighting the need for thorough evaluation and reporting of such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hearing loss following the use of topical otitis therapeutics in dogs]. Neubert, A., Tannert, S., Pirk, G.[2022]

A study involving 289 teenagers revealed that many young listeners use personal listening devices (PLDs) at high volume levels, with an average of 82 dBA in quiet and 89 dBA in background noise, indicating a potential risk for hearing loss.

Over 25% of participants listening in noisy environments were found to be at risk of hearing damage based on established occupational safety criteria, highlighting the need for increased awareness about safe listening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred listening levels of personal listening devices in young teenagers: self reports and physical measurements. Muchnik, C., Amir, N., Shabtai, E., et al.[2012]

The study introduces a new method for accurately calculating noise exposure from Personal Listening Devices (PLDs), achieving 98.8% accuracy in measuring sound-pressure levels, which is crucial for preventing hearing loss.

The developed Safe Listening Personal Listening Device (SL-PLD) and accompanying Safe Listening Application (SL-APP) provide real-time monitoring and control of listening doses, alerting users when they exceed safe listening levels, thereby promoting safer listening habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing Care: Safe Listening Method and System for Personal Listening Devices. Chen, F., Xue, H., Wang, M., et al.[2023]

Some personal sound amplification products (PSAPs) can provide adequate amplification for common types of hearing loss, with two high-end PSAPs meeting all necessary electroacoustic tolerances in a controlled study.

In clinical tests, a representative PSAP (RPSAP) improved hearing compared to no device but performed slightly worse than conventional hearing aids, suggesting it may be a useful alternative for individuals with moderate hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. Kim, GY., Kim, JS., Jo, M., et al.[2022]

The study found significant differences in the performance of personal FM systems when using teleloops compared to direct input, indicating that the method of connection can greatly affect sound quality.

Various factors, such as hearing aid orientation, distance from the loop, and clothing interference, were shown to significantly impact the effectiveness of FM systems, suggesting that these should be carefully considered in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacoustic characteristics of personal FM systems. Hawkins, DB., Van Tasell, DJ.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Hardwire Personal Assistive Listening Devices. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

[Hearing loss following the use of topical otitis therapeutics in dogs]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Preferred listening levels of personal listening devices in young teenagers: self reports and physical measurements. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Hearing Care: Safe Listening Method and System for Personal Listening Devices. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. [2018]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Mild-Gain Hearing Aids as a Treatment for Adults with Self-Reported Hearing Difficulties. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Electroacoustic characteristics of personal FM systems. [2019]