3D-Printed vs Conventional Ear Tips for Comfort

Overseen By Bryan Wong, AuD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Ear pathology, Ear surgery, Neurological, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether 3D-printed ear tips match or surpass regular ear tips in sound quality, comfort, and fit. It also evaluates the production speed and cost of each type. Participants will test various ear tips, including those made from flexible materials. Eligible participants should have normal hearing and healthy ears. As an unphased trial, this study allows participants to contribute to innovative research that could enhance ear tip technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these ear tips are safe for use?

Research has shown that 3D-printed ear tips are generally safe and comfortable. Made from body-safe materials, they are designed to fit well and feel good. Their use in various hearing products for over 20 years suggests a strong safety record.

Known for precision and efficiency, 3D-printed ear devices can enhance the user's experience without significant risks. Although specific reports of problems with 3D-printed ear tips are not detailed in the sources, their long-term use in similar products provides reassurance about their safety.

Traditional ear tips, also compared in this study, have been widely used and are generally considered safe. Both types of ear tips aim to provide a comfortable and effective solution for hearing needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of using 3D-printed ear tips over conventional ones for enhanced comfort. Unlike standard ear tips, which are mass-produced, these 3D-printed versions are crafted using biocompatible resins that can be tailored for a more personalized fit. This approach could lead to increased comfort and reduced irritation for users. By investigating both standard and flexible resin options, this trial aims to discover which material provides the best combination of comfort and adaptability, potentially setting a new standard for ear tip design.

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

This trial will compare 3D-printed ear tips with conventional ones for comfort. Research has shown that 3D-printed ear tips can be more comfortable and accurate than regular ear tips. One study found that these 3D-printed ear tips fit the ear better, enhancing sound quality and comfort. The process involves scanning the ear to create a custom fit, saving time and effort compared to traditional methods. Additionally, 3D printing uses flexible materials, making the ear tips more comfortable to wear. Overall, this technology shows promise for creating hearing devices that are both effective and personalized. Participants in this trial will receive either 3D-printed ear tips made with biocompatible or flexible resin, or conventional ear tips fabricated by a third-party manufacturer. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with normal hearing who are willing to try out different types of ear tips on behind-the-ear (BTE) hearing aids. Specific eligibility criteria were not provided, so it's assumed that participants should be in good general health and have no known allergies or conditions related to the ear.

Inclusion Criteria

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

Exclusion Criteria

History of neurological or cognitive disorder

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

2-4 weeks

Treatment

Participants are fitted with different types of ear tips (3D-printed and conventional) and evaluated for comfort and acoustic performance

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for satisfaction and effectiveness of ear tips after the treatment sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Printed Ear Tips
• Conventional Ear Tips

Trial Overview The study is testing if 3D-printed ear tips can provide better sound quality, comfort, and fit compared to conventional ones. It will also assess the production time and cost differences between these two types of earmolds used with BTE hearing aids.

How Is the Trial Designed?

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

ear tips fabricated using biocompatible resin

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

ear tips fabricated using biocompatible flexible resin

Group III: Third-party control Active Control 1 Intervention

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 ... 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 ...

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

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8743309/

Current Application and Future Prospects of 3D Printing in ... 3D printing technology saves time and manual labour in creating individualized outer shells. Instead of creating an ear mould, the ear can be scanned and ...

4. piocreat3d.com piocreat3d.com/3d-printing-custom-ear-molds-benefits-in-hearing-healthcare/

3D Printing Custom Ear Molds: Benefits in Hearing ... 3D printing has transformed the production of custom ear molds, allowing for unparalleled accuracy, comfort, and efficiency in hearing healthcare.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352940724003482

3D printed personalized assistive devices: A material, ... This review thoroughly examines 3D-printed P&Os from various perspectives: material composition, printing techniques, and specific medical conditions.

6. safetyandhealthmagazine.com safetyandhealthmagazine.com/articles/24620-custom-earbud-and-communication-sleeves

Custom earbud and communication sleeves Chameleon Ears PRO Custom Earbud Sleeves are supersoft hydrophobic silicone sleeves that improve comfort and sound while eliminating the danger of losing an ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9023952/

Assessing the efficacy of 3D-printed ear protectors on mask ... Our results suggest that simple cost-effective 3D-printed ear protectors may improve fit, comfort, and overall mask compliance. The results of this study ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070920301988

3d printed custom made pressure clips for ear keloid ... The aim of this study is to introduce the efficacy of our 3D printer custom made pressure adjustable clips for preventing keloid recurrence after ear keloid ...

9. reddit.com reddit.com/r/3Dprinting/comments/n4jbl1/just_noticed_that_my_customized_hearing/

Just noticed that my customized hearing protection seems ... Any custom hearing aid is more then likely 3d printed and have been doing this for 20+ years. If it is hard plastic it's straight off the print.