Hearing Aids for Hearing Loss (IHAT Trial)

N/A

Recruiting

Led By Anu Sharma, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation

Aged 40 years or older

Must not have

Asymmetrical hearing loss

Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the Montreal Cognitive Assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1= 6 months post intervention, t2= 12 months post intervention

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare over-the-counter (OTC) hearing aids to prescription hearing aids fitted by specialists in people with mild to moderate hearing loss. The study will look at how each type of hearing aid

Who is the study for?

The IHAT study is for individuals with mild to moderate hearing loss. It's designed to compare different ways of getting hearing aids, including over-the-counter options and those fitted by specialists.

What is being tested?

This trial tests four service models for providing hearing aids: HA-HCP (prescription), OTC-R (regular over-the-counter), OTC-HCP (over-the-counter with healthcare professional advice), and OTC-SF (self-fitting). The impact on user experience, behavior, cognition, and brain activity will be evaluated.

What are the potential side effects?

While traditional side effects are not applicable in this context as it involves non-invasive devices rather than drugs or surgery, users may experience discomfort or dissatisfaction with the device fit or function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have adult-onset hearing loss in both ears, confirmed by a hearing test.

Select...

I am 40 years old or older.

Exclusion Criteria

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

Select...

I have hearing loss that is worse in one ear.

Select...

I have a neurological condition like dementia or Parkinson's, or scored below 25 on a cognitive test.

Select...

My hearing loss is too severe for regular hearing aids.

Select...

I have a middle ear disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1= 6 months post intervention, t2= 12 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1= 6 months post intervention, t2= 12 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1= 6 months post intervention, t2= 12 months post intervention for reporting.