Innovations in Hearing Accessibility and Technology (IHAT) Study (IHAT)

November 15, 2024 updated by: University of Colorado, Denver

Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medicine
        • Contact:
        • Principal Investigator:
          • Vinaya Manchaiah, AuD, MBA, PhD
      • Boulder, Colorado, United States, 80305
        • Recruiting
        • University of Colorado Boulder
        • Contact:
        • Principal Investigator:
          • Anu Sharma, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time Frame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention
It is a 24-item self-reported measure of hearing disability and hearing aid benefit. It includes four subscales that address different listening challenges: ease of communication, reverberation, background noise, and aversiveness of sounds, with each subscales comprising six items. The ease of communication, reverberation, and background noise primarily measure challenges related to speech communication. The global score on the APHAB is the average of these three subscale scores. The hearing aid benefit is calculated by comparing the difficulty level reported without amplification (unaided) to the difficulty level with amplification (aided). Scores range from 1% to 99%, with higher scores indicating greater perceived hearing difficulty.
T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Amplification in Daily Living (SADL)
Time Frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
SADL is a 15-item self-reported outcome measure that evaluates an individual's satisfaction with their hearing aids on a 7-point rating scale. The questionnaire is divided into four subscales. The positive effect subscale quantifies improved performance with hearing aids. The personal image subscale quantifies self-image and stigma. The negative feature subscale evaluates undesirable aspects of using hearing aids. The service and cost subscale assesses the adequacy of the professional's service and the device's cost. Higher scores indicate greater satisfaction with hearing aids.
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Revised Hearing Handicap Inventory -Screening (RHHI-S)
Time Frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
It is a 10-item self-perceived hearing handicap measure that can be used for adults of all ages. The response options on this scale are yes (4), sometimes (2), and no (0), and ranges from 0 to 40. The total score is the sum of all the responses, with higher scales indicating greater perceived difficulties.
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Patient Global Impression of Change (PGI-C)
Time Frame: T1= 6 months post intervention, T2= 12 months post intervention
PGI-C assesses the patient's belief about the efficacy of treatment with a single-item questionnaire on a 7-point rating scale. Lower scores indicate improved outcomes.
T1= 6 months post intervention, T2= 12 months post intervention
Connected Speech Test (CST)
Time Frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
The connected speech test is a sentence intelligibility test consisting of 48 passages with 8-10 sentences of a connected discourse spoken by a female speaker. A pair of passages will be presented to the participant, and the 25 keywords in each passage will be scored for percentage correct score. A higher percentage correct score indicates higher sentence intelligibility.
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Quick Speech in Noise (QuickSIN)
Time Frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
It assesses the patient's ability to hear in background noise. The patient repeats sentences that are embedded in different noisy environments and the result is a signal-to-noise ratio loss. The test stimuli are pre-recorded sentences embedded in speech babble at varying signal-to-noise ratios from easy to very difficult.
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Vinaya Manchaiah, AuD, MBA, PhD, University of Colorado, Denver
  • Principal Investigator: Anu Sharma, PhD, University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2351
  • R01DC021653 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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