Hearing AidsNCT07216937
Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
A study testing BTE hearing aid with compatible earmolds in people with Hearing Aids and 3D Printing, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Aids, 3D Printing
- What is being tested?
- BTE hearing aid with compatible earmolds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 14 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.
- Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
- English speaking.
Who cannot join
- history of extensive or current outer or middle ear pathology.
- history of extensive outer or middle ear surgery.
- history of neurological or cognitive disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Arizona Hearing Clinic
Tucson, Arizona, 85719
Bryan Wong, AuD, PhD, 5206268549, bryanwong@arizona.edu
About this study
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. It will also compare how long each method takes to make and how much each costs.
- Conditions
- Hearing Aids, 3D Printing
- Being tested
- BTE hearing aid with compatible earmolds
- Keywords
- hearing aids, 3D printing, hearing healthcare accessibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTE hearing aid with compatible earmoldsDevice
Hearing aids will be fit with three different types of customized ear tips. They will only wear each ear tip group for the duration of the test (total = 20 minutes). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 40 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear ear tip group.
| Study group | Role | What they receive |
|---|---|---|
| In-house Study group_Resin | Experimental | ear tips fabricated using biocompatible resin Receives: Device: BTE hearing aid with compatible earmolds |
| Third-party control | Active comparator | ear tips fabricated by third party manufacturer using biocompatible resin Receives: Device: BTE hearing aid with compatible earmolds |
| In-house Study group_FlexibleResin | Experimental | ear tips fabricated using biocompatible flexible resin Receives: Device: BTE hearing aid with compatible earmolds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real Ear Measures
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house_Resin, in-house_FlexResin). Then, 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. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.
Measured: 2nd listening session appointment (15 minutes)
Outer EAR comfort questionnaire
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.
Measured: 2nd listening session appointment (10 minutes)
Secondary outcomes (2)
Cost
The total raw cost ($, dollars US)
Measured: Prior to second listening session appointment (15 minutes)
Time
time-to-subject for each eartip type
Measured: Prior to second listening appointment (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start7 Nov 2025
- Primary completion20 May 2026 (estimated)
- Study completion14 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing AidsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Wong, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216937
- Sponsor's protocol ID
- 00005737
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
- ClinicalTrials.gov ID
- NCT07216937
- Acronym / sponsor ID
- 00005737
- Conditions
- Hearing Aids, 3D Printing
- Keywords
- hearing aids, 3D printing, hearing healthcare accessibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 14 Jun 2026 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It will also compare how long each method takes to make and how much each costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-house Study group_Resin | Experimental | Device: BTE hearing aid with compatible earmoldsear tips fabricated using biocompatible resin |
| Third-party control | Active comparator | Device: BTE hearing aid with compatible earmoldsear tips fabricated by third party manufacturer using biocompatible resin |
| In-house Study group_FlexibleResin | Experimental | Device: BTE hearing aid with compatible earmoldsear tips fabricated using biocompatible flexible resin |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.
- Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
- English speaking.
Key exclusion criteria (3 listed)
- history of extensive or current outer or middle ear pathology.
- history of extensive outer or middle ear surgery.
- history of neurological or cognitive disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTE hearing aid with compatible earmoldsHearing aids will be fit with three different types of customized ear tips. They will only wear each ear tip group for the duration of the test (total = 20 minutes). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 40 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear ear tip group. | Device | In-house Study group_FlexibleResin, In-house Study group_Resin, Third-party control |
Primary outcome
Real Ear Measures
Time frame: 2nd listening session appointment (15 minutes)
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house_Resin, in-house_FlexResin). Then, 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. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.
Outer EAR comfort questionnaire
Time frame: 2nd listening session appointment (10 minutes)
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.
2 secondary outcomes
Cost
Time frame: Prior to second listening session appointment (15 minutes)
Time
Time frame: Prior to second listening appointment (15 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Aids
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Not yet recruitingObservational study
New Hearing Aid Users and Their Social Participation
Hearing Loss, Hearing Aids
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTE hearing aid with compatible earmolds in people with Hearing Aids and 3D Printing, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Wong, AuD, PhD (520-626-8549, bryanwong@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real Ear Measures (time frame: 2nd listening session appointment (15 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.