Innovations in Hearing Accessibility and Technology (IHAT) Study

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: OTC Hearing Aids; Hearing Loss; Hearing Aids

Treatments: Device: OTC-R; Device: OTC-HCP; Device: OTC-SF; Device: HA-HCP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06689865

23-2351

R01DC021653 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

HA-HCP

Active Comparator group

Treatment:

Device: HA-HCP

OTC-HCP

Experimental group

Treatment:

Device: OTC-HCP

OTC-R

Experimental group

Treatment:

Device: OTC-R

OTC-SF

Active Comparator group

Treatment:

Device: OTC-SF