Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range

University of Arizona

Status: Enrolling

Conditions: 3D Printing; Hearing Aids

Treatments: Device: BTE hearing aid with compatible earmolds

Study type: Interventional

Funder types: Other

Identifiers

NCT07216937

00005737

Details and patient eligibility

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. It will also compare how long each method takes to make and how much each costs.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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 extensive or current outer or middle ear pathology.
• history of extensive outer or middle ear surgery.
• history of neurological or cognitive disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

In-house Study group_Resin

Experimental group

Description:

ear tips fabricated using biocompatible resin

Treatment:

Device: BTE hearing aid with compatible earmolds

Third-party control

Active Comparator group

Description:

ear tips fabricated by third party manufacturer using biocompatible resin

Treatment:

Device: BTE hearing aid with compatible earmolds

In-house Study group_FlexibleResin

Experimental group

Description:

ear tips fabricated using biocompatible flexible resin

Treatment:

Device: BTE hearing aid with compatible earmolds