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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC021653 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA-HCP | Active Comparator |
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| OTC-HCP | Experimental |
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| OTC-R | Experimental |
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| OTC-SF | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HA-HCP | Device | Prescription hearing aid fit by a hearing healthcare professional using audiology best practices. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Service Professional | Contact | 303-724-8465 | ihat@cuanschutz.edu | |
| Preeti Pandey, PhD | Contact | preeti.pandey@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vinaya Manchaiah, AuD, MBA, PhD | University of Colorado, Denver | Principal Investigator |
| Anu Sharma, PhD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37052929 | Background | De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376. | |
| 38990557 | Background | De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):765-771. doi: 10.1001/jamaoto.2024.1825. |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| OTC-HCP | Device | Over-the-counter hearing aids fit by a hearing care professional using audiology best practices. |
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| OTC-R | Device | OTC fit to an individual using some best practices via remote consultation. |
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| OTC-SF | Device | Self-fit OTC hearing aids without any clinical support from HCPs. |
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| T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention |
| 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. | T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention |
| 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. | T1= 6 months post intervention, T2= 12 months post intervention |
| 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. | T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention |
| Quick Speech in Noise (QuickSIN) | 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 |
| University of Colorado Boulder | Recruiting | Boulder | Colorado | 80305 | United States |
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| 39052241 | Background | Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |