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

University of Arizona30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Aids 3D Printing

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The University of Arizona Hearing Clinic

Tucson, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2nd listening session appointment (10 minutes)

Secondary Outcomes

Cost

The total raw cost ($, dollars US)

Time frame: Prior to second listening session appointment (15 minutes)

Time

time-to-subject for each eartip type

Time frame: Prior to second listening appointment (15 minutes)

Central Contacts

Bryan Wong, AuD, PhD

CONTACT

520-626-8549 bryanwong@arizona.edu

Data from ClinicalTrials.gov

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