Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06689865

Effectiveness Trial to Examine Service Delivery Models for Over-the-Counter and Prescription Hearing Aids

Led by University of Colorado, Denver · Updated on 2024-11-19

280

Participants Needed

2

Research Sites

12 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying different ways to provide over-the-counter (OTC) hearing aids compared to traditional prescription hearing aids fitted by specialists for adults with mild to moderate hearing loss. The goal is to understand how each hearing aid option affects users' hearing experiences, behavior, thinking skills, and brain activity. The study also looks at which people prefer each type, what helps or hinders their choices, and compares the costs of four service delivery models. This information aims to help healthcare providers and policymakers apply research findings in real-world settings. The study compares four groups: prescription hearing aids fitted by hearing care professionals using best audiology practices, OTC hearing aids fitted by professionals in person, OTC hearing aids fitted via remote consultation, and self-fit OTC hearing aids without clinical support. This is a randomized controlled trial with repeated measures over time to assess the different service models. Participants aged 40 and older with mild to moderate hearing loss will join the study and be randomly assigned to one of the four groups. They will be evaluated at the start, then again at 6 months and 12 months after intervention using questionnaires and hearing tests. Researchers will measure hearing aid benefits, satisfaction, hearing difficulties, speech comprehension, and overall impression of change. The study will last at least one year, with ongoing monitoring of participants' hearing outcomes and experiences.

CONDITIONS

Brief Title

Innovations in Hearing Accessibility and Technology (IHAT) Study

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
  • Aged 40 years or older
  • No previous hearing aid experience greater than 3 months
  • Able to read and understand patient education materials
  • Willing to be randomized to one of the four groups
  • Owns a smartphone
Not Eligible

You will not qualify if you...

  • Hearing loss too severe for over-the-counter hearing aids
  • Middle ear disorders or conductive hearing issues present
  • Asymmetrical hearing loss
  • Diagnosed neurological conditions such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
  • Non-English speaking which may affect completing study tests

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Initial fitting and adjustment period at baseline

Participants receive hearing aids fitted according to their randomization group, including prescription hearing aids by professionals or over-the-counter models with varying levels of clinical support.

1 baseline visit (in-person or remote depending on group)

Long-term Monitoring

Duration - 12 months

Participants are monitored to evaluate the effectiveness and satisfaction with the assigned hearing aids over time.

Follow-up visits at 6 months and 12 months post intervention

Trial Site Locations

Total: 2 locations

1

University of Colorado School of Medicine

Aurora, Colorado, United States, 80045

Actively Recruiting

2

University of Colorado Boulder

Boulder, Colorado, United States, 80305

Actively Recruiting

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Research Team

R

Research Service Professional

P

Preeti Pandey, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.

Karina C De Sousa, Vinaya Manchaiah, David R Moore...

https://pubmed.ncbi.nlm.nih.gov/37052929