Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Barriers and Facilitators to OTC Hearing Aids Success
Sponsor:
Yu-Hsiang Wu
Organization:
University of Iowa
Study Overview
Official Title:
Barriers and Facilitators to OTC Hearing Aids Success
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hearing aids can improve hearing communication and overall quality of life for people with hearing loss However not many people use hearing aids A common reason is that hearing aids are expensive and hard to get The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss customizing the aids and ongoing maintenance This traditional method is called the AUD pathway
Over-the-counter OTC hearing aids offer a different approach They aim to make hearing aids more affordable and accessible encouraging earlier use In the OTC pathway users diagnose their own hearing loss and fit and program the hearing aids themselves Little is known about long-term effects of OTC hearing aids on users
This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway It takes place in two locations Iowa City IA and Nashville TN Participants who have mild-to-moderate hearing loss choose their preferred pathway and are followed for 12 months In the OTC pathway participants buy their hearing aids directly from OTC companies or retailers In the AUD pathway prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center
Participants are contacted 1 6 and 12 months after starting to use their hearing aids Researchers measure their satisfaction about hearing aids and other outcomes If participants stop using their hearing aids researchers assess their engagement with post-amplification hearing care The results from both pathways are then compared
Over-the-counter OTC hearing aids offer a different approach They aim to make hearing aids more affordable and accessible encouraging earlier use In the OTC pathway users diagnose their own hearing loss and fit and program the hearing aids themselves Little is known about long-term effects of OTC hearing aids on users
This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway It takes place in two locations Iowa City IA and Nashville TN Participants who have mild-to-moderate hearing loss choose their preferred pathway and are followed for 12 months In the OTC pathway participants buy their hearing aids directly from OTC companies or retailers In the AUD pathway prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center
Participants are contacted 1 6 and 12 months after starting to use their hearing aids Researchers measure their satisfaction about hearing aids and other outcomes If participants stop using their hearing aids researchers assess their engagement with post-amplification hearing care The results from both pathways are then compared
Detailed Description:
Although hearing aids HAs can improve hearing ability communication social and emotional function and quality of life for people with hearing loss the adoption rate of HAs is low A commonly reported barrier to HA uptake is that HAs are not affordable or accessible under the traditional service delivery model which requires multiple visits to licensed audiologists for identification of hearing loss customization of the HAs and continual maintenance and fine-tuning This hearing healthcare pathway is referred to as the AUD pathway As an alternative over-the-counter OTC HAs aim to promote earlier HA adoption and improve HA affordability and accessibility In this healthcare pathway referred to as the OTC pathway users self-diagnose hearing loss and fit and program their OTC HAs Although prior research has supported the feasibility of HA self-fitting and the OTC service-delivery model little is known about how the OTC pathway impacts users long-term well-being
The goal of this study is to characterize the patient journey of individuals who opt for the OTC pathway in comparison to those who select the AUD pathway The study is a two-site Iowa City IA and Nashville TN longitudinal study in which participants choose their preferred healthcare pathways OTC vs AUD and their HA outcomes are tracked for 12 months Adults with bilateral mild-to-moderate hearing loss are recruited from the community Upon entering the study participants choose their preferred pathway and then proceed with the purchase of HAs In the OTC pathway participants purchase their chosen OTC HAs directly from OTC companies or retailers In the AUD pathway prescription HAs and fitting services are offered by the audiology clinics at the University of Iowa and Vanderbilt University Medical Center Participants are contacted 1 6 and 12 months after they begin using their HAs During each contact HA outcomes eg HA satisfaction are measured if participants continue using HAs If participants have abandoned or under-utilized their HAs their engagement with post-amplification hearing healthcare behaviors eg seeking HAs again is assessed The data from the OTC and AUD pathways are then compared
The goal of this study is to characterize the patient journey of individuals who opt for the OTC pathway in comparison to those who select the AUD pathway The study is a two-site Iowa City IA and Nashville TN longitudinal study in which participants choose their preferred healthcare pathways OTC vs AUD and their HA outcomes are tracked for 12 months Adults with bilateral mild-to-moderate hearing loss are recruited from the community Upon entering the study participants choose their preferred pathway and then proceed with the purchase of HAs In the OTC pathway participants purchase their chosen OTC HAs directly from OTC companies or retailers In the AUD pathway prescription HAs and fitting services are offered by the audiology clinics at the University of Iowa and Vanderbilt University Medical Center Participants are contacted 1 6 and 12 months after they begin using their HAs During each contact HA outcomes eg HA satisfaction are measured if participants continue using HAs If participants have abandoned or under-utilized their HAs their engagement with post-amplification hearing healthcare behaviors eg seeking HAs again is assessed The data from the OTC and AUD pathways are then compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DC015997 | NIH | None | None |