Innovations in Hearing Accessibility and Technology (IHAT) Study

Not Applicable

Recruiting

• Conditions: Hearing Loss; Hearing Aids; OTC Hearing Aids

• Registration Number: NCT06689865
• Lead Sponsor: University of Colorado, Denver

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-13
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Abbreviated Profile of Hearing Aid Benefit (APHAB)	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with Amplification in Daily Living (SADL)	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.
Revised Hearing Handicap Inventory -Screening (RHHI-S)	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.
Patient Global Impression of Change (PGI-C)	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.
Connected Speech Test (CST)	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.
Quick Speech in Noise (QuickSIN)	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.

Trial Locations

Locations (2)

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States