NCT07228845 · University of Arizona
Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Outer EAR comfort questionnaire
Time frame: through study completion, an average of 1 week
A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function/rating.
Real Ear Measures
Time frame: through study completion, an average of 1 week
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house\_Resin, in-house\_FlexResin). A thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss
- Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
- English speaking.
Exclusion criteria
- Self reported history of extensive or current outer or middle ear pathology.
- Self reported history of extensive outer or middle ear surgery.
- Self reported history of neurological or cognitive disorder.
- Active ear infection
Where
- Tucson, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations