Recruiting

Hearing Accessibility

Sponsor:

University of Colorado, Denver

Code:

NCT06689865

Conditions

Hearing Loss

Hearing Aids

OTC Hearing Aids

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

HA-HCP

OTC-HCP

OTC-R

OTC-SF

Study Details

Brief summary:

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

Hearing Loss

Hearing Aids

OTC Hearing Aids

Study ID

NCT06689865

Start date

Nov 13, 2024

Status verified date

Nov, 2024

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: HA-HCP

experimental: OTC-HCP

experimental: OTC-R

active comparator: OTC-SF

Interventions

HA-HCP

Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.

OTC-HCP

Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.

OTC-R

OTC fit to an individual using some best practices via remote consultation.

OTC-SF

Self-fit OTC hearing aids without any clinical support from HCPs.

Primary outcome measure

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention ]

Central Contacts and Locations

Central contacts

Research Service Professional

303-724-8465ihat@cuanschutz.edu

Preeti Pandey, PhD

preeti.pandey@cuanschutz.edu

Locations

University of Colorado School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Research Service Professional

303-724-8465ihat@cuanschutz.edu

Principal Investigator:

Vinaya Manchaiah, AuD, MBA, PhD

University of Colorado Boulder

Recruiting

Boulder, Colorado, United States, 80305

Contacts

Research Service Professional

303-724-8465ihat@cuanschutz.edu

Principal Investigator:

Anu Sharma, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 19, 2024

Last verified

Nov, 2024

Keywords

  • hearing loss
  • hearing aids
  • OTC hearing aids
  • service delivery models
  • effectiveness trial
  • Over-the-counter hearing aids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-11-19.