What is the mechanism of action of this treatment?

Personal amplifiers work by increasing the volume of sound, making it easier for individuals with hearing loss to hear and understand speech and environmental noises. This is particularly beneficial in settings where clear communication is essential, such as in emergency departments, to ensure patients understand discharge instructions and reduce the risk of readmission. Other common treatments for hearing loss include hearing aids, which amplify sound and improve speech clarity, and cochlear implants, which bypass damaged parts of the ear and directly stimulate the auditory nerve. These treatments are crucial for improving the quality of life and daily functioning of individuals with hearing loss.

What side effects are associated with this type of intervention?

The most common treatments for hearing loss, such as hearing aids and personal amplifiers, generally have minimal side effects. Users may experience initial discomfort or irritation in the ear canal, feedback noise, and occasional headaches. Some individuals might find the amplification of background noise bothersome. Proper fitting and adjustment by an audiologist can mitigate many of these issues. Overall, these devices are considered safe and effective for improving hearing and understanding in individuals with hearing loss.

What prior FDA approvals exist?

The FDA has approved various treatments for hearing loss, primarily focusing on assistive listening devices such as hearing aids and cochlear implants. Hearing aids amplify sound and are commonly used to improve hearing in individuals with presbycusis or other forms of hearing impairment. Cochlear implants are another FDA-approved option for severe hearing loss, providing direct electrical stimulation to the auditory nerve. While there are ongoing studies on pharmacological treatments and personal amplifiers to enhance hearing and understanding, no specific drugs have been FDA-approved solely for the treatment of hearing loss.

What other types of research exist?

Promising novel alternatives to personal amplifiers for hearing loss patients in 2024 include cochlear implants with hybrid hearing capabilities and optogenetic stimulation for cochlear implants. These technologies have the potential to significantly improve hearing and understanding of discharge instructions.

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Personal Amplifier for Hearing Loss (HearVA-ED Trial)

N/A

Recruiting

Led By Joshua Chodosh, MD MSHS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Inability to consent to participate in research

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 days after initial ed stay

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive interventions like personal amplifiers rather than medications or surgeries, significant side effects are not anticipated.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to give consent for research participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-5 days after initial ed stay

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-5 days after initial ed stay

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 days after initial ed stay for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ED 3-day Readmissions

Secondary study objectives

ED 30-day Readmissions

Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay

Patient-Rated Quality of Post-Discharge Care

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention: Personal AmplifierExperimental Treatment1 Intervention

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

Group II: Control: No Personal AmplifierExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Personal amplifiers work by increasing the volume of sound, making it easier for individuals with hearing loss to hear and understand speech and environmental noises. This is particularly beneficial in settings where clear communication is essential, such as in emergency departments, to ensure patients understand discharge instructions and reduce the risk of readmission. Other common treatments for hearing loss include hearing aids, which amplify sound and improve speech clarity, and cochlear implants, which bypass damaged parts of the ear and directly stimulate the auditory nerve. These treatments are crucial for improving the quality of life and daily functioning of individuals with hearing loss.

[Biological therapies in otology. German version].The CD2 isoform of protocadherin-15 is an essential component of the tip-link complex in mature auditory hair cells.Technologic advances in aural rehabilitation: applications and innovative methods of service delivery.