Print

Purpose

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation - Aged 40 years or older - No previous HA experience greater than 3 months - Able to read and understand patient education materials - Willing to be randomized to one of the four groups, and - Owns a smartphone

Exclusion Criteria

  • Hearing loss that is too severe for OTC HAs - Middle ear disorders or conductive pathology present - Asymmetrical hearing loss - Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA - Non-English speaking as it may impact the ability to complete our test battery

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
HA-HCP
  • Device: HA-HCP
    Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
Experimental
OTC-HCP
  • Device: OTC-HCP
    Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
Experimental
OTC-R
  • Device: OTC-R
    OTC fit to an individual using some best practices via remote consultation.
Active Comparator
OTC-SF
  • Device: OTC-SF
    Self-fit OTC hearing aids without any clinical support from HCPs.

Recruiting Locations

University of Colorado School of Medicine
Aurora, Colorado 80045
Contact:
Research Service Professional
303-724-8465
ihat@cuanschutz.edu

University of Colorado Boulder
Boulder, Colorado 80305
Contact:
Research Service Professional
303-724-8465
ihat@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Research Service Professional
303-724-8465
ihat@cuanschutz.edu

Detailed Description

The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.