Innovations in Hearing Accessibility and Technology (IHAT) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HA-HCP
DevicePrescription hearing aid fit by a hearing healthcare professional using audiology best practices.
OTC-HCP
DeviceOver-the-counter hearing aids fit by a hearing care professional using audiology best practices.
OTC-R
DeviceOTC fit to an individual using some best practices via remote consultation.
OTC-SF
DeviceSelf-fit OTC hearing aids without any clinical support from HCPs.
Treatment groups
280 Participants
are divided into 4 treatment groupsGroup A: HA-HCPActive comparator 1 intervention
Group B: OTC-HCPExperimental treatment 1 intervention
Group C: OTC-RExperimental treatment 1 intervention
Group D: OTC-SFActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Abbreviated Profile of Hearing Aid Benefit (APHAB)
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.
Time frame
T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post interventionSecondary outcomes
1
Satisfaction with Amplification in Daily Living (SADL)
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.
Time frame
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention2
Revised Hearing Handicap Inventory -Screening (RHHI-S)
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.
Time frame
T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention3
Patient Global Impression of Change (PGI-C)
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.
Time frame
T1= 6 months post intervention, T2= 12 months post intervention4
Connected Speech Test (CST)
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.
Time frame
T0= Baseline, T1= 6 months post intervention, T2= 12 months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov