Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
BTE hearing aid with compatible earmolds
DeviceHearing 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: In-house Study group_ResinExperimental treatment 1 intervention
Group B: Third-party controlActive comparator 1 intervention
Group C: In-house Study group_FlexibleResinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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
1
Cost
The total raw cost ($, dollars US)
Time frame
Prior to second listening session appointment (15 minutes)2
Time
time-to-subject for each eartip type
Time frame
Prior to second listening appointment (15 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov