3D-Printed Ear Tips for Hearing Loss

Overseen By Bryan Wong, AuD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Ear pathology, Ear surgery, Neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests 3D-printed ear tips to determine if they improve sound quality, comfort, and fit for people with hearing loss. Researchers compare these new ear tips to standard ones to identify which is better and more affordable. The trial includes different groups, each testing various types of 3D-printed ear tips made from special materials. Individuals with hearing loss in both ears and healthy ear structures may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for hearing loss.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to check with the trial organizers for more details.

What prior data suggests that 3D-printed ear tips are safe for individuals with hearing loss?

Research has shown that 3D-printed ear tips are generally safe and comfortable. Studies on 3D-printed hearing aids have not identified any major safety issues. The materials used, such as special resins, are designed to be body-safe.

This technology customizes ear tips to fit each person's ear perfectly, preventing discomfort or irritation. The use of 3D printing for hearing aids is becoming more common in healthcare, proving it to be a reliable method for making these devices.

In summary, based on past research, 3D-printed ear tips appear safe. They are made from body-friendly materials and designed for comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D-printed ear tips for hearing loss because they offer a customizable fit that traditional hearing aids can't match. These ear tips are made using biocompatible resin and flexible resin, allowing for a more comfortable and personalized experience. Unlike standard hearing aids, which often require multiple fittings and adjustments, 3D printing technology can produce ear tips that perfectly match the unique contours of each user's ear. This innovation could lead to improved sound quality and user satisfaction, making hearing assistance more effective and accessible.

What evidence suggests that 3D-printed ear tips are effective for hearing loss?

Research has shown that 3D-printed ear tips match regular ear tips in sound quality, comfort, and fit. Studies have found that digital scans can customize these 3D-printed ear tips to fit a person's ear perfectly. This precise fit can enhance comfort and the overall hearing experience. Evidence also suggests that 3D printing can speed up and reduce the cost of production, potentially making hearing aids more affordable. In this trial, participants will receive various types of 3D-printed ear tips, including those made in-house with biocompatible or flexible resin, and those produced by a third party. Overall, 3D-printed ear tips hold significant potential to improve hearing aid technology. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with bilateral hearing loss who are interested in testing the comfort and fit of ear tips used with BTE (behind-the-ear) hearing aids. The study will compare standard ear tips to those made using 3D printing technology.

Inclusion Criteria

I have hearing loss in both ears that is not too mild or too severe.

Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally

English speaking

Exclusion Criteria

I currently have an ear infection.

I have a history of serious ear problems.

I have had major surgery on my outer or middle ear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 3D-printed or conventional ear tips and are evaluated for sound quality, comfort, and fit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Printed Ear Tips

Trial Overview The study is examining if 3D-printed ear tips can match or surpass the performance of conventional ones in terms of sound quality, comfort, and fit. Participants will try different types of ear tips over a period to assess these factors.

How Is the Trial Designed?

Group I: In-house Study group_Resin Experimental Treatment 1 Intervention

participants will initially receive ear tips fabricated using biocompatible resin

Group II: In-house Study group_FlexibleResin Experimental Treatment 1 Intervention

Participants will initially receive ear tips fabricated using biocompatible flexible resin

Group III: Third-party Manufactured Active Control 1 Intervention

participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216937

Effectiveness Comparison of 3D-Printed and Conventional Ear ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07228845?term=Nervous+System+Diseases

Effectiveness Comparison of 3D-Printed and Conventional ... 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 ...

3. trial.medpath.com trial.medpath.com/clinical-trial/70a4d473e5bab0d9/nct07216937-3d-printed-vs-conventional-ear-tip-comfort

Effectiveness Comparison of 3D-Printed and Conventional ... Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range. Not Applicable. Not ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950174/

A 3D Printed Human Ear Model for Standardized Testing of ... A 3D printed TB that can model the mechanical response of the ear from blast and acoustic stimuli would be greatly beneficial to the development of HPDs.

5. salyerhearingcenter.com salyerhearingcenter.com/the-impact-of-3d-printing-on-hearing-aid-manufacturing/

The Impact of 3D Printing on Hearing Aid Manufacturing With 3D printing, audiologists can now create shells and earmolds that are shaped precisely for your ear using digital scans. This custom-fit ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0928493120335244

Anti-biofilm multi drug-loaded 3D printed hearing aids We describe for the first time, the use of 3D printing to fabricate hearing aids loaded with two antibiotics, ciprofloxacin and fluocinolone acetonide.

7. drteeleinnovativehearing.com drteeleinnovativehearing.com/3d-printed-hearing-aids-a-game-changer-in-customization/

3D-Printed Hearing Aids: A Game-Changer in Customization This technology is a game-changer in the world of hearing care, offering a level of customization that surpasses what traditional methods can achieve.

8. amfg.ai amfg.ai/2025/02/19/application-spotlight-3d-printed-hearing-aids/

Application Spotlight: 3D Printed Hearing Aids 3D printing has revolutionised hearing aid production. Healthcare applications have paved the way for AM technology being used in high volume production lines.