Last reviewed · How we verify
NCT06499805
Barriers and Facilitators to OTC Hearing Aids Success
NA trial testing Audiologist-based fitting in Hearing Loss, Sensorineural in 360 participants. Currently enrolling.
1 April 2029
Quick facts
| Lead sponsor | Yu-Hsiang Wu |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 15 March 2025 |
| Primary completion | 1 April 2029 |
| Estimated completion | 1 April 2029 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Audiologist-based fitting
- Over-the-counter fitting
Conditions studied
- Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →
- Presbycusis — all drugs for Presbycusis →
Sponsor
Yu-Hsiang Wu
Who can join
Adults 18 to 89, any sex, with Hearing Loss, Sensorineural or Presbycusis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06499805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Audiologist-based fitting
Trials testing the same drug.
- NCT04049643 — Hearing Aid and Individuals With Cognitive Disorders · NA · completed
Other recruiting trials for Hearing Loss, Sensorineural
Currently open trials in the same condition.
- NCT06560918 — Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids · NA · recruiting
- NCT06882889 — Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL · NA · recruiting
- NCT06664697 — Post-Market Clinical Investigation of the IotaSOFT Insertion System · recruiting
- NCT06268340 — Hearing and Structure Preservation Via ECochG · NA · recruiting
- NCT06664710 — Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery · NA · recruiting
Other Yu-Hsiang Wu trials
Trials by the same sponsor.
- NCT04049643 — Hearing Aid and Individuals With Cognitive Disorders · NA · completed
- NCT04030299 — Longitudinal Outcomes of Hearing Aids · NA · completed
- NCT03579563 — Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06499805 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yu-Hsiang Wu
- Last refreshed: 21 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06499805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing