Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids.
Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/38990557/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2024-11-19
280
Participants Needed
2
Research Sites
12 weeks
Total Duration
Researchers are studying different ways to provide over-the-counter OTC hearing aids compared to traditional prescription hearing aids fitted by specialists for adults with mild to moderate hearing loss. The goal is to understand how each hearing aid option affects users hearing experiences, behavior, thinking skills, and brain activity. The study also looks at which people prefer each type, what helps or hinders their choices, and compares the costs of four service delivery models. This information aims to help healthcare providers and policymakers apply research findings in real-world settings. The study compares four groups prescription hearing aids fitted by hearing care professionals using best audiology practices, OTC hearing aids fitted by professionals in person, OTC hearing aids fitted via remote consultation, and self-fit OTC hearing aids without clinical support. This is a randomized controlled trial with repeated measures over time to assess the different service models. Participants aged 40 and older with mild to moderate hearing loss will join the study and be randomly assigned to one of the four groups. They will be evaluated at the start, then again at 6 months and 12 months after intervention using questionnaires and hearing tests. Researchers will measure hearing aid benefits, satisfaction, hearing difficulties, speech comprehension, and overall impression of change. The study will last at least one year, with ongoing monitoring of participants hearing outcomes and experiences.
CONDITIONS
Innovations in Hearing Accessibility and Technology (IHAT) Study
R
Research Service Professional
P
Preeti Pandey, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Colorado, Denver
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Prescription HA (Audiologist Fit) | OTC HA (Audiologist Fit) | OTC HA (Remote Fitting) | OTC HA (Self-Fit) |
|---|---|---|---|---|
| What is it? | Prescription hearing aids are individually programmed and professionally fit by a licensed audiologist, using gold-standard audiology best practices. | Over-the-counter hearing aids fit by an audiologist or hearing care professional, using audiology best practices to guide and optimize device settings. | OTC hearing aids fit to an individual through remote consultation with a hearing care professional applying best practices, typically through telehealth. | OTC hearing aids that are self-fit by the user, without any clinical support or adjustments from a hearing care professional. |
| Role in study | Serves as the gold-standard, prescription-based comparator for device fitting. | Tests if OTC devices, when fit by a professional, can provide similar outcomes to prescription hearing aids. | Assesses the effectiveness of remote professional fitting for OTC hearing aids compared to in-person fitting. | Examines outcomes for self-fit OTC hearing aids without professional involvement, reflecting fully independent use. |
| Primary use | Providing individualized amplification for hearing loss via a prescription hearing aid programmed by an audiologist. | Making OTC hearing aids available with audiologist guidance for adults seeking clinical-level support. | Offering OTC hearing amplification with some professional guidance provided remotely, enabling access to expert adjustment without a clinic visit. | Self-guided hearing aid fitting and amplification for mild-to-moderate hearing loss using OTC devices purchased and fit without any clinical support. |
| How is it given or performed? | A licensed hearing care professional conducts a full evaluation, programs the hearing aid, and provides in-person device fitting and adjustment. | The user selects an OTC device but has it fit and adjusted in-person by an audiologist. | After purchase, the OTC device is fit with support from a professional via remote consultation (e.g., videoconference, phone). | The user independently configures and fits the OTC hearing aids using available instructions and self-guided setup, without professional input. |
| Evidence status | Prescription hearing aids programmed and fit by audiologists are supported by long-term evidence, with clinical trials demonstrating significant improvement in hearing-related outcomes compared to unaided states. Outcomes may be similar to best-practice OTC strategies in selected populations. | Evidence suggests that OTC hearing aids fit by hearing professionals may offer similar hearing benefits to prescription devices for adults with mild-to-moderate hearing loss, when professional fitting follows best practices. | The clinical evidence for remote professional fitting of OTC hearing aids is still emerging but current research supports comparable short- and medium-term outcomes to traditional in-person fittings when best practices are followed remotely. | Well-conducted randomized clinical trials demonstrate that self-fitted OTC hearing aids can yield similar hearing benefit to professional fitting for many adults with mild-to-moderate hearing loss, particularly when devices are selected and set up according to best available instructions. |
| Important limitations | Professional fitting requires multiple in-person clinic visits, specialized equipment, and greater cost, potentially limiting access for some adults. Outcomes depend on device programming quality and follow-up. | Professional clinical support may reduce potential fit errors with OTC devices, but in-person visits may still limit access and costs are not always covered by insurance. Device limitations are similar to OTC self-fit, and real-world access to skilled support varies. | Remote fitting can broaden access but may be challenging for adults without digital skills or reliable internet connection. The effectiveness may be lower in people needing more hands-on support, and evidence is less mature. | Self-fit OTC hearing aids require the user to independently manage all setup and troubleshooting, which works best for individuals who are comfortable with technology. Limited support may hinder outcomes for those with complex loss or limited tech literacy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial fitting and adjustment period at baseline
Participants receive hearing aids fitted according to their randomization group, including prescription hearing aids by professionals or over-the-counter models with varying levels of clinical support.
1 baseline visit (in-person or remote depending on group)
Duration - 12 months
Participants are monitored to evaluate the effectiveness and satisfaction with the assigned hearing aids over time.
Follow-up visits at 6 months and 12 months post intervention
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Have more questions? Get in touch with our team for quick support
Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/38990557/Megan Knoetze, Vinaya Manchaiah, Karina De Sousa...
https://pubmed.ncbi.nlm.nih.gov/39052241/Karina C De Sousa, Vinaya Manchaiah, David R Moore...
https://pubmed.ncbi.nlm.nih.gov/37052929/University of Colorado, Denver
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor