Personal Amplifier for Hearing Loss

(HearVA-ED Trial)

Recruiting at 7 trial locations

Overseen By Lin T Tun

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: High acuity, Cochlear implants, others

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

Compensation: Varies

Number of Visits: 3

1050 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personal amplifiers (devices that amplify sound to assist with hearing) can help Veterans with hearing difficulties in emergency departments. The researchers seek to find out if these devices can improve hearing, enhance understanding of discharge instructions, and reduce quick returns to the hospital. The study consists of two parts: the first tests the effectiveness and acceptability of the devices, while the second assesses whether emergency staff can successfully provide these devices to patients. Veterans who speak English, can consent to participate, and often struggle to hear in busy places like emergency rooms may find this trial suitable.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve the emergency care experience for Veterans with hearing difficulties.

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.

What prior data suggests that this personal amplifier is safe for hearing loss patients?

Research has shown that personal amplifiers, which help people hear better, are generally safe for humans. Studies have found no major safety differences between these devices and basic hearing aids. For instance, a study with 56 adults who had mild to moderate hearing loss found that using personal amplifiers was as safe as using basic hearing aids. Participants reported no serious side effects, indicating that these devices are well-tolerated.

Personal amplifiers boost sound, making it easier for people to understand speech and other important sounds. This can be especially useful in places like a hospital emergency room, where clear communication is crucial. Overall, evidence suggests that personal amplifiers are a safe choice for improving hearing without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personal amplifier for hearing loss because it offers a simple and potentially more accessible alternative to traditional hearing aids. Unlike most hearing aids, which can be expensive and require professional fitting, personal amplifiers are typically more affordable and user-friendly. This treatment aims to enhance sound without the need for complex adjustments, making it easier for individuals with hearing loss to improve their hearing experience quickly and independently.

What evidence suggests that personal amplifiers are effective for hearing loss?

Research has shown that personal amplifiers can greatly assist people with hearing loss. These devices improve hearing and make it easier for patients to follow conversations. In this trial, participants will be randomly assigned to either receive a personal amplifier or join a control group without one. Previous studies comparing personal amplifiers to basic hearing aids found both equally effective for those with mild to moderate hearing loss. Another study found that personal amplifiers particularly improve communication for older adults. Overall, these devices effectively aid hearing and could reduce misunderstandings or the need for repeated emergency room visits. ^{1 2 3 6 7}

Who Is on the Research Team?

Joshua Chodosh, MD MSHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

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

I am unable to give consent for research participation.

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

You have a cochlear implant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• No Personal Amplifier
• Personal Amplifier

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.

How Is the Trial Designed?

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+

New York University Grossman School of Medicine

Collaborator

Trials

2

Recruited

1,300+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Adults with normal hearing sensitivity but self-reported hearing difficulties (HD) experience a significant hearing handicap and auditory processing challenges, indicating that standard hearing tests may not fully capture their needs.

A four-week trial of mild-gain amplification showed significant improvements in hearing handicap, auditory processing difficulties, and speech-in-noise performance for adults with HD, suggesting that this treatment could be beneficial for this unique population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild-Gain Hearing Aids as a Treatment for Adults with Self-Reported Hearing Difficulties. Roup, CM., Post, E., Lewis, J.[2020]

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]

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]

Some direct-to-consumer hearing devices, like personal sound amplification products (PSAPs) and over-the-counter (OTC) hearing aids, can produce dangerously high sound levels, which may pose safety risks for users.

Despite lower satisfaction rates compared to professionally purchased hearing aids, OTC devices show potential benefits, especially when supported by hearing health care professionals, indicating a need for further research to better understand their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. Manchaiah, V., Taylor, B., Dockens, AL., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9006672/

Comparison of personal sound amplification products and ... The main objective of this study was to compare the efficacy of PSAPs and conventional hearing aids regarding hearing benefits in patients with hearing loss.

2. jkms.org jkms.org/pdf/10.3346/jkms.2024.39.e179

A Prospective Randomized Crossover Trial Background: This study compared hearing outcomes with use of personal sound amplification products (PSAPs) and hearing aids (HAs) in patients ...

3. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.18784

The clinical use of personal hearing amplifiers in facilitating ... Personal hearing amplifiers (PHAs), (e.g., Pocketalkers™), can improve communication with older patients. Methods. We conducted a scoping review ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2023_AJA-23-00121

Efficacy and Effectiveness of Evidence-Based Non–Self ... In this study, we compare the efficacy and effectiveness of gain–frequency responses of evidence-based presets developed by our lab for ...

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2733788

Clinical Evaluation of a PSAP vs a Basic Hearing Aid and ... Findings In this cohort study of 56 adults, for those with mild and moderate hearing loss, there were no differences between PSAP, basic HA, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589004222017084

Article Smartphone-bundled earphones as personal sound ... Unaddressed hearing loss functionally limits effective communication and can result in a reduced quality of life, as well as risky patterns of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6233940/

Outcomes of Direct-to-Consumer Hearing Devices for ... Outcomes show benefit of either type of amplification regardless of delivery method. Participants with no gain hearing aids did not have same benefits. ...