Hearing LossIHATNCT06689865
Innovations in Hearing Accessibility and Technology (IHAT) Study
A study testing HA-HCP, OTC-HCP and OTC-R in people with Hearing Loss and Hearing Aids, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hearing Loss, Hearing Aids, OTC Hearing Aids
- What is being tested?
- HA-HCP, OTC-HCP and OTC-R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Preeti Pandey, PhD contact
United States2 sites, 2 recruiting
- Recruiting
University of Colorado School of Medicine
Aurora, Colorado, 80045
Research Service Professional, 303-724-8465, ihat@cuanschutz.edu
Vinaya Manchaiah, AuD, MBA, PhD
- Recruiting
University of Colorado Boulder
Boulder, Colorado, 80305
Research Service Professional, 303-724-8465, ihat@cuanschutz.edu
Anu Sharma, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Hearing Aids, OTC Hearing Aids
- Being tested
- HA-HCP, OTC-HCP, OTC-R, OTC-SF
- Keywords
- hearing loss, hearing aids, OTC hearing aids, service delivery models, effectiveness trial, Over-the-counter hearing aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA-HCPDevice
Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
OTC-HCPDevice
Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
OTC-RDevice
OTC fit to an individual using some best practices via remote consultation.
OTC-SFDevice
Self-fit OTC hearing aids without any clinical support from HCPs.
| Study group | Role | What they receive |
|---|---|---|
| HA-HCP | Active comparator | Not described Receives: Device: HA-HCP |
| OTC-HCP | Experimental | Not described Receives: Device: OTC-HCP |
| OTC-R | Experimental | Not described Receives: Device: OTC-R |
| OTC-SF | Active comparator | Not described Receives: Device: OTC-SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start13 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Vinaya Manchaiah, AuD, MBA, PhD, Principal investigator, University of Colorado, DenverAnu Sharma, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689865
- Sponsor's protocol ID
- 23-2351
- Other IDs
- R01DC021653
- Acronym
- IHAT
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 37052929De 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.
PubMed 38990557Knoetze 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.
PubMed 39052241
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
- ClinicalTrials.gov ID
- NCT06689865
- Acronym / sponsor ID
- IHAT / 23-2351
- Conditions
- Hearing Loss, Hearing Aids, OTC Hearing Aids
- Keywords
- hearing loss, hearing aids, OTC hearing aids, service delivery models, effectiveness trial, Over-the-counter hearing aids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HA-HCP | Active comparator | Device: HA-HCP |
| OTC-HCP | Experimental | Device: OTC-HCP |
| OTC-R | Experimental | Device: OTC-R |
| OTC-SF | Active comparator | Device: OTC-SF |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA-HCPPrescription hearing aid fit by a hearing healthcare professional using audiology best practices. | Device | HA-HCP |
| OTC-HCPOver-the-counter hearing aids fit by a hearing care professional using audiology best practices. | Device | OTC-HCP |
| OTC-ROTC fit to an individual using some best practices via remote consultation. | Device | OTC-R |
| OTC-SFSelf-fit OTC hearing aids without any clinical support from HCPs. | Device | OTC-SF |
Primary outcome
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.
5 secondary outcomes
Satisfaction with Amplification in Daily Living (SADL)
Time frame: 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
Patient Global Impression of Change (PGI-C)
Time frame: 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
Quick Speech in Noise (QuickSIN)
Time frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 37052929De 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.
- Background: PubMed 38990557De 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.
- Background: PubMed 39052241Knoetze 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Preeti Pandey, PhD contact
Vinaya Manchaiah, AuD, MBA, PhD principal investigator
University of Colorado, Denver
Anu Sharma, PhD principal investigator
University of Colorado, Boulder
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA-HCP, OTC-HCP and OTC-R in people with Hearing Loss and Hearing Aids, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Service Professional (303-724-8465, ihat@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689865, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.