Trials / Not Yet Recruiting
Not Yet RecruitingNCT07228845
Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin) | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group. |
| DEVICE | BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin) | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group |
| DEVICE | BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes) | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group |
Timeline
- Start date
- 2026-01-15
- Primary completion
- 2027-01-15
- Completion
- 2027-04-15
- First posted
- 2025-11-14
- Last updated
- 2025-11-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07228845. Inclusion in this directory is not an endorsement.