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

University of Arizona

Status: Not yet enrolling

Conditions: 3D Printing; Hearing Loss, Bilateral Sensorineural; Hearing Aids

Treatments: Device: BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin); Device: BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin); Device: BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)

Study type: Interventional

Funder types: Other

Identifiers

NCT07228845

5737

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 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

In-house Study group_Resin

Experimental group

Description:

participants will initially receive ear tips fabricated using biocompatible resin

Treatment:

Device: BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)

Third-party Manufactured

Active Comparator group

Description:

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

Treatment:

Device: BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)

In-house Study group_FlexibleResin

Experimental group

Description:

Participants will initially receive ear tips fabricated using biocompatible flexible resin

Treatment:

Device: BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)